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Amiodarone Safety Reports submitted to FDA

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Total Amiodarone reports: 336.
Amiodarone FDA safety alerts: 2001 2005 .
Reported deaths: 49    Reported hospitalizations: 143.
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FDA Reported Amiodarone Side Effects: hyperthyroidism, hypothyroidism, atrial fibrillation, dyspnoea, asthenia, condition aggravated, pulmonary fibrosis, hyperglobulinaemia, bradycardia, hypotension, cardiac failure congestive.
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Amiodarone Side Effects Report #5327847-1
Health Professional from JAPAN reported AMIODARONE problem on May 07, 2007. Female patient, 90 years of age, was diagnosed with arrhythmia, hypothyroidism and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: coma, condition aggravated, hypothyroidism. AMIODARONE dosage: unknown. During the same period patient was treated with THYRADIN. Patient recovered.

Amiodarone Side Effects Report #5328151-8
AMIODARONE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on May 01, 2007. Male patient, 61 years of age, was diagnosed with ventricular fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: application site discolouration, blister, infusion site extravasation, oedema peripheral, skin necrosis. AMIODARONE dosage: 900 MG IV. Patient recovered.

Amiodarone Side Effects Report #5330661-4
Health Professional from FRANCE reported AMIODARONE problem on May 16, 2007. Female patient, 81 years of age, was diagnosed with atrial fibrillation, cellulitis, hypothyroidism and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, dyspnoea, erythema, heart rate increased, hyperhidrosis. AMIODARONE dosage: unknown. During the same period patient was treated with TEICOPLANIN, PREDNISOLONE, CLINDAMYCIN, THYROXINE. Patient recovered.

Amiodarone Side Effects Report #5333137-3
AMIODARONE problem was reported by a Consumer or non-health professional from UNITED STATES on May 09, 2007. Female patient, 85 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, coma, haemorrhage intracranial. AMIODARONE dosage: 200MG, QD, ORAL. During the same period patient was treated with WARFARIN. Patient was hospitalized. Patient died.

Amiodarone Side Effects Report #5333302-5
Health Professional from FRANCE reported AMIODARONE problem on Jan 26, 2007. Male patient, 54 years of age, weighting 155.2 lb, was diagnosed with ventricular tachycardia and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: bradycardia, cardiac failure, condition aggravated, defibrillation threshold increased. AMIODARONE dosage: unknown. During the same period patient was treated with DIGOXIN. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5339681-7
AMIODARONE problem was reported by a Physician from UNITED STATES on May 14, 2007. Male patient, 72 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: hyperglobulinaemia. AMIODARONE dosage: unknown. During the same period patient was treated with HYPERGLOBULINEMIA IN AMIODARONE. Patient recovered.

Amiodarone Side Effects Report #5339684-2
Physician from UNITED STATES reported AMIODARONE problem on May 14, 2007. Male patient, 60 years of age, was diagnosed with ventricular tachycardia and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: hyperglobulinaemia. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5339686-6
AMIODARONE problem was reported by a Physician from UNITED STATES on May 14, 2007. Male patient, 68 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: hyperglobulinaemia. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5339687-8
Physician from UNITED STATES reported AMIODARONE problem on May 14, 2007. Female patient, 84 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: hyperglobulinaemia. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5339695-7
AMIODARONE problem was reported by a Physician from ISRAEL on May 14, 2007. Male patient, 80 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: hyperglobulinaemia, pneumonitis. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5339696-9
Physician from ISRAEL reported AMIODARONE problem on May 14, 2007. Male patient, 84 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: hyperglobulinaemia, pneumonitis. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5339697-0
AMIODARONE problem was reported by a Physician from ISRAEL on May 14, 2007. Female patient, 90 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: hyperglobulinaemia. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5339698-2
Physician from ISRAEL reported AMIODARONE problem on May 14, 2007. Male patient, 83 years of age, was diagnosed with supraventricular tachycardia and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: hyperglobulinaemia, hypothyroidism. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5339701-X
AMIODARONE problem was reported by a Physician from ISRAEL on May 14, 2007. Male patient, 75 years of age, was diagnosed with ventricular tachycardia and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: hyperglobulinaemia, pneumonitis. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5339776-8
Consumer or non-health professional from UNITED STATES reported AMIODARONE problem on May 14, 2007. Female patient, 81 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: hyperglobulinaemia, pneumonitis. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5339777-X
AMIODARONE problem was reported by a Physician from UNITED STATES on May 14, 2007. Male patient, 72 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: hypothyroidism. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5339779-3
Physician from UNITED STATES reported AMIODARONE problem on May 14, 2007. Female patient, 68 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: hyperglobulinaemia, pneumonitis. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5339780-X
AMIODARONE problem was reported by a Physician from UNITED STATES on May 14, 2007. Female patient, 72 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: hyperglobulinaemia, pneumonitis. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5339782-3
Physician from UNITED STATES reported AMIODARONE problem on May 14, 2007. Female patient, 83 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: hyperglobulinaemia. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5339783-5
AMIODARONE problem was reported by a Physician from UNITED STATES on May 14, 2007. Male patient, 87 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: hyperglobulinaemia, pneumonitis. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5340109-1
Pharmacist from UNITED STATES reported AMIODARONE problem on May 25, 2007. Male patient, 81 years of age, weighting 129.4 lb, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: chills, chronic obstructive pulmonary disease, dyspnoea, oxygen saturation decreased, pneumonia, pulmonary fibrosis, pulmonary mass, pulmonary toxicity, pyrexia. AMIODARONE dosage: 200MG DAY PO. During the same period patient was treated with LEVAQUIN, ZANTAC, LIPITOR, ASPIRIN, ZETIA, ARICEPT, NORVASC. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5341578-3
AMIODARONE problem was reported by a Health Professional from FRANCE on May 22, 2007. Male patient, 65 years of age, was diagnosed with atrial fibrillation, septic shock and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: condition aggravated, hypoproteinaemia, hypothyroidism, pleural effusion, wound secretion. AMIODARONE dosage: unknown. During the same period patient was treated with LANOXIN, DOPAMINE. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5345867-8
Health Professional from JAPAN reported AMIODARONE problem on May 25, 2007. Female patient, 90 years of age, was diagnosed with arrhythmia, hypothyroidism and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: blood glucose decreased, coma, condition aggravated, hypothyroidism. AMIODARONE dosage: unknown. During the same period patient was treated with THYRADIN. Patient died on 01/01/2007.

Amiodarone Side Effects Report #5350937-4
AMIODARONE problem was reported by a Health Professional from JAPAN on May 31, 2007. Male patient, 58 years of age, was diagnosed with ventricular tachycardia and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: chest x-ray abnormal. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5353550-8
Health Professional from JAPAN reported AMIODARONE problem on June 05, 2007. Male patient, 63 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: anorexia, pleural effusion, pulmonary oedema. AMIODARONE dosage: unknown. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5357419-4
AMIODARONE problem was reported by a Health Professional from FRANCE on June 04, 2007. Male patient, 82 years of age, was diagnosed with atrial flutter, acute coronary syndrome and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: hypotension, interstitial lung disease, lethargy. AMIODARONE dosage: unknown. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5360438-5
Health Professional from FRANCE reported AMIODARONE problem on June 12, 2007. Female patient, 75 years of age, was diagnosed with pulmonary hypertension and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, respiratory depression. AMIODARONE dosage: unknown. During the same period patient was treated with ALLOPURINOL, VIAGRA. Patient was hospitalized. Patient died on 03/24/2006.

Amiodarone Side Effects Report #5361743-9
AMIODARONE problem was reported by a Health Professional from UNITED STATES on May 30, 2007. Male patient, 76 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: gastrointestinal disorder, gastrointestinal hypomotility, ileus, intestinal obstruction, small intestinal obstruction. AMIODARONE dosage: 200 MG (1 IN 1 D). Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5362234-1
Health Professional from ROMANIA reported AMIODARONE problem on June 14, 2007. Female patient, 23 years of age, was diagnosed with tachycardia and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: cardiopulmonary failure, pyelonephritis acute. AMIODARONE dosage: 300 MG ONCE. Patient died on 06/01/2007.

Amiodarone Side Effects Report #5366256-6
AMIODARONE problem was reported by a Consumer or non-health professional from UNITED STATES on June 19, 2007. Male patient, 63 years of age, weighting 161.4 lb, was diagnosed with atrial fibrillation, cardiac failure, hypertension and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: bradycardia, dizziness, electrocardiogram qt prolonged, hypotension, urine output decreased, ventricular tachycardia. AMIODARONE dosage: 400 MG EVERY 8 HOURS PO. During the same period patient was treated with METOPROLOL SUCCINATE, METOPROLOL SUCCINATE. Patient recovered.

Amiodarone Side Effects Report #5370419-3
Pharmacist from UNITED STATES reported AMIODARONE problem on June 25, 2007. Male patient, weighting 211.6 lb, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: hyperthyroidism, pyrexia, tremor, weight decreased. AMIODARONE dosage: 200MG QAM (PO). Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5373209-0
AMIODARONE problem was reported by a Health Professional from JAPAN on June 20, 2007. Male patient, 82 years of age, was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: hypothyroidism, pulmonary fibrosis. AMIODARONE dosage: unknown. Patient died on 06/01/2007.

Amiodarone Side Effects Report #5375659-5
Consumer or non-health professional from UNITED STATES reported AMIODARONE problem on June 15, 2007. Male patient, 76 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: ileus, small intestinal obstruction. AMIODARONE dosage: 200 MG (1 IN 1 D);. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5046719-3
AMIODARONE problem was reported by a Physician from UNITED STATES on July 05, 2006. Male patient, 73 years of age, weighting 176.0 lb, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: chromaturia, hepatic enzyme increased, hepatic pain, malaise, no therapeutic response. AMIODARONE dosage: ORAL 150 MG BID. During the same period patient was treated with INDOPAMIDE, NORVASC, LISINOPRIL. Patient recovered.

Amiodarone Side Effects Report #5046845-9
Consumer or non-health professional from UNITED STATES reported AMIODARONE problem on July 05, 2006. Male patient, 68 years of age, weighting 350.0 lb, was diagnosed with heart rate irregular and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: cardiac failure congestive, ill-defined disorder, lung disorder. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5047751-6
AMIODARONE problem was reported by a Pharmacist from UNITED STATES on July 10, 2006. Male patient, 84 years of age, weighting 145.5 lb, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: atrial tachycardia, lung disorder, pulmonary function test abnormal, restrictive pulmonary disease. AMIODARONE dosage: 200 MG QDAY PO. During the same period patient was treated with ASPIRIN, DOCUSATE NA, FUROSEMIDE, ISOSORBIDE DINITRATE, KETOCONAZOLE, SYNTHROID, LISINOPRIL. Patient recovered.

Amiodarone Side Effects Report #5047794-2
Consumer or non-health professional from UNITED STATES reported AMIODARONE problem on May 16, 2006. Male patient, 72 years of age, was diagnosed with coronary artery bypass and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, asthenia, blood creatine phosphokinase increased, blood urea increased, chromaturia, myoglobin blood increased, myoglobin urine present, pain. AMIODARONE dosage: 200MG, QD, ORAL. During the same period patient was treated with SIMVASTATIN, METFORMIN, ENALAPRIL MALEATE, GLIMEPIRIDE, HYDROCHLOROTHIAZIDE, ASPIRIN. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5047798-X
AMIODARONE problem was reported by a Physician from UNITED STATES on May 16, 2006. Male patient, 69 years of age, was diagnosed with arrhythmia and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: asthenia, cough, dyspnoea, pulmonary alveolar haemorrhage, weight decreased. AMIODARONE dosage: 200MG, QD, ORAL. During the same period patient was treated with ASPIRIN, LANSOPRAZOLE, LEVOTHYROXINE, METHOCARBAMOL, METOPROLOL TARTRATE, OXYCODONE, RISPERIDONE. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5047832-7
Pharmacist from UNITED STATES reported AMIODARONE problem on July 10, 2006. Male patient, 84 years of age, weighting 145.5 lb, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, atrial tachycardia, pulmonary function test decreased, restrictive pulmonary disease. AMIODARONE dosage: 200 MG QDAY PO. During the same period patient was treated with PACERONE, ASPIRIN, DOCUSATE, FUROSEMIDE, ISOSORBIDE DINITRATE, KETOCONAZOLE, SYNTHROID, LISINOPRIL. Patient recovered.

Amiodarone Side Effects Report #5048715-9
AMIODARONE problem was reported by a Health Professional from UNITED KINGDOM on June 29, 2006. Male patient was diagnosed with ventricular tachycardia and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: lower respiratory tract infection, shock, ventricular tachycardia. AMIODARONE dosage: 400 MG 1X PER 1 DAY; SEE IMAGE; (FOR 7 YEARS AT A DOSE OF 200 MG DAILY FOR MOST OF THE TIME). Patient was hospitalized. Patient died.

Amiodarone Side Effects Report #5049238-3
Physician from UNITED STATES reported AMIODARONE problem on June 26, 2006. Male patient, 74 years of age, was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, granuloma, pancytopenia. AMIODARONE dosage: unknown. During the same period patient was treated with BUMETANIDE, LEUPROLIDE ACETATE, LOSARTAN POTASSIUM, SPIRONOLACTONE, TAMSULOSIN, WARFARIN, VITAMIN. Patient recovered.

Amiodarone Side Effects Report #5050800-2
AMIODARONE problem was reported by a Health Professional from ISRAEL on June 27, 2006. Female patient, 38 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: activated partial thromboplastin time prolonged, ascites, cardiac arrest, dilatation ventricular, hepatomegaly, hyperthyroidism, jugular vein distension, leukocytosis, neutrophilia. AMIODARONE dosage: unknown. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5051960-X
Consumer or non-health professional from UNITED STATES reported AMIODARONE problem on June 22, 2006. Female patient, 85 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: dyspnoea, weight decreased. AMIODARONE dosage: 200MG, QD, ORAL. During the same period patient was treated with TOPROL, WARFARIN, DIGITEK. Patient recovered.

Amiodarone Side Effects Report #5053291-0
AMIODARONE problem was reported by a Health Professional from TURKEY on July 04, 2006. Male patient, weighting 8.16 lb, was diagnosed with supraventricular tachycardia and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: blood aldosterone increased, bradycardia, hyperkalaemia, neonatal disorder, renin increased, supraventricular tachycardia. AMIODARONE dosage: unknown. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5053596-3
Consumer or non-health professional from ITALY reported AMIODARONE problem on June 29, 2006. Male patient, 55 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: anxiety, burning sensation, feeling hot, hyperhidrosis, hypotension, infusion related reaction, musculoskeletal pain, rash. AMIODARONE dosage: 150 MG ONCE INTRAVENOUS. During the same period patient was treated with ENOXAPARIN, VALSARTAN, LAROXYL, TACHIPIRINA. Patient recovered.

Amiodarone Side Effects Report #5060978-2
AMIODARONE problem was reported by a Pharmacist from UNITED STATES on July 20, 2006. Female patient, 88 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: cardiac failure congestive, condition aggravated, pulmonary congestion, pulmonary fibrosis, pulmonary function test abnormal, pulmonary hypertension, rales, sinus bradycardia. AMIODARONE dosage: 200 MG BID PO. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5061086-7
Pharmacist from UNITED STATES reported AMIODARONE problem on July 19, 2006. Male patient, 75 years of age, weighting 268.0 lb, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: hypothyroidism, muscular weakness. AMIODARONE dosage: 200 MG DAILY PO. During the same period patient was treated with CLONAZEPAM, FLUNISOLIDE, FELODIPINE, LISINOPRIL, TAMSULOSIN, LEVOTHYROXINE, SIMVASTATIN, WARFARIN. Patient recovered.

Amiodarone Side Effects Report #5062460-5
AMIODARONE problem was reported by a Consumer or non-health professional from AUSTRALIA on July 13, 2006. Female patient, 87 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: cataract nuclear, corneal lesion, disease recurrence, keratopathy, post procedural complication. AMIODARONE dosage: 200 MG QD. Patient recovered.

Amiodarone Side Effects Report #5066019-5
Pharmacist from UNITED STATES reported AMIODARONE problem on July 31, 2006. Male patient, 73 years of age, weighting 266.8 lb, was diagnosed with arrhythmia and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: hypothyroidism. AMIODARONE dosage: 200 MG DAILY PO. Patient recovered.

Amiodarone Side Effects Report #5066267-4
AMIODARONE problem was reported by a Pharmacist from UNITED STATES on July 31, 2006. Male patient, 21 years of age, weighting 89.99 lb, was diagnosed with ventricular arrhythmia and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, defibrillation threshold increased, white blood cell count decreased. AMIODARONE dosage: 200 MG DAILY PO. During the same period patient was treated with LASIX, FERROUS SULPHATE, FOLIC ACID, BIDIL, COUMADIN. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5067403-6
Health Professional from POLAND reported AMIODARONE problem on July 12, 2006. Male patient, 74 years of age, was diagnosed with ventricular fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: chest x-ray abnormal, haemoptysis, ill-defined disorder, pulmonary haemorrhage. AMIODARONE dosage: unknown. During the same period patient was treated with TICLOPIDINE, CLOPIDOGREL. Patient recovered.

Amiodarone Side Effects Report #5069038-8
AMIODARONE problem was reported by a Consumer or non-health professional from ICELAND on July 20, 2006. Female patient, 74 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: cryptogenic organising pneumonia, dyspnoea exertional, respiratory failure. AMIODARONE dosage: unknown. Patient died.

Amiodarone Side Effects Report #5069039-X
Consumer or non-health professional from ICELAND reported AMIODARONE problem on July 20, 2006. Male patient, 80 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: cryptogenic organising pneumonia. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5069976-6
AMIODARONE problem was reported by a Consumer or non-health professional from FRANCE on July 12, 2006. Male patient, 62 years of age, was diagnosed with atrial fibrillation, dysthymic disorder and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: cerebral haemorrhage, coagulation time prolonged, coma, international normalised ratio increased. AMIODARONE dosage: 400 MG (200 MG, 2 IN 1 D). During the same period patient was treated with PREVISCAN, PAROXETINE, EQUANIL, FUROSEMIDE, EBIXA. Patient was hospitalized. Patient died.

Amiodarone Side Effects Report #5070103-X
Health Professional from POLAND reported AMIODARONE problem on July 12, 2006. Male patient, 74 years of age, was diagnosed with ventricular fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: chest x-ray abnormal, haemoptysis, pulmonary haemorrhage, ventricular fibrillation. AMIODARONE dosage: unknown. During the same period patient was treated with TICLODIPINE, CLOPIDOGREL. Patient recovered.

Amiodarone Side Effects Report #5078698-7
AMIODARONE problem was reported by a Pharmacist from UNITED STATES on June 30, 2006. Female patient, 79 years of age, weighting 180.8 lb, was diagnosed with arrhythmia and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: extravasation. AMIODARONE dosage: 900MG/500MG/IV. Patient recovered.

Amiodarone Side Effects Report #5069419-2
Pharmacist from UNITED STATES reported AMIODARONE problem on Aug 02, 2006. Male patient, 56 years of age, weighting 231.5 lb, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, condition aggravated, hyperthyroidism. AMIODARONE dosage: 200 MG PO Q DAY. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5070088-6
AMIODARONE problem was reported by a Pharmacist from UNITED STATES on Aug 01, 2006. Male patient, 69 years of age, weighting 154.3 lb, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, atrophy, bone disorder, cholelithiasis, dysphagia, dysphonia, inflammation, lung injury. AMIODARONE dosage: 200 MG DAILY PO. During the same period patient was treated with ATENOLOL, AZITHROMYCIN, DOXCYCLINE HYCLATE, FELODIPINE, LANCET, LISINOPRIL, NYSTATIN. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5072857-5
Health Professional from JAPAN reported AMIODARONE problem on July 28, 2006. Male patient, 56 years of age, was diagnosed with dilatation ventricular, ventricular arrhythmia and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: cardiac failure, cerebral artery embolism, cerebral infarction, condition aggravated, interstitial lung disease, paralysis, pulmonary congestion, respiratory disorder. AMIODARONE dosage: 100 MG 1X PER 1 DAY ORAL; 2 TABLET 1X PER 1 DAY ORAL. During the same period patient was treated with BLOPRESS, LASIX, CARVEDILOL, MUCOSTA. Patient was hospitalized. Patient died.

Amiodarone Side Effects Report #5075705-2
AMIODARONE problem was reported by a Health Professional from JAPAN on July 31, 2006. Male patient was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: melaena, pancytopenia. AMIODARONE dosage: 200 MG 1X PER 1 DAY ORAL. During the same period patient was treated with WARFARIN, DIGOXIN, LASIX, ALDACTONE, PANALDINE, FAMOTIDINE, ISOSORBIDE MONONITRATE, SENNA. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5076946-0
Physician from UNITED STATES reported AMIODARONE problem on June 02, 2006. Female patient, weighting 185.0 lb, was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: catheterisation cardiac, coma. AMIODARONE dosage: unknown. During the same period patient was treated with COREG, NEURONTIN, HYDROCHLOROTHIAZIDE, AMBIEN, LANTUS, NORVASC, TOPROL, LISINOPRIL. Patient was hospitalized. Patient died on 05/16/2006.

Amiodarone Side Effects Report #5079107-4
AMIODARONE problem was reported by a Health Professional from POLAND on July 27, 2006. Male patient, 74 years of age, was diagnosed with ventricular fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: chest x-ray abnormal, haemoglobin decreased, haemoptysis, pulmonary haemorrhage, pyrexia. AMIODARONE dosage: unknown. During the same period patient was treated with TICLOPIDINE, CLOPIDOGREL, INDOBUFEN, ASPIRIN, HEPARIN, BETA BLOCKING AGENTS, ACE INHIBITOR NOS. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5080357-1
Pharmacist from UNITED STATES reported AMIODARONE problem on Aug 14, 2006. Male patient, 67 years of age, weighting 208.8 lb, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: pulmonary fibrosis, respiratory distress. AMIODARONE dosage: 200 MG THREE TIMES DAILY PO. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5080667-8
AMIODARONE problem was reported by a Health Professional from ICELAND on Aug 01, 2006. Female patient, 74 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: cardiac disorder, cryptogenic organising pneumonia, respiratory failure. AMIODARONE dosage: unknown. Patient died.

Amiodarone Side Effects Report #5080714-3
Health Professional from JAPAN reported AMIODARONE problem on July 28, 2006. Male patient, 57 years of age, was diagnosed with ventricular tachycardia and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: anxiety disorder, bronchopneumonia, cardiac failure congestive, gastric ulcer, hepatic function abnormal, hypertension, thyroiditis, ventricular fibrillation, ventricular tachycardia. AMIODARONE dosage: 200 MG 2X PER 1 DAY ORAL - SEE IMAGE. During the same period patient was treated with DIGOXIN, SPIRONOLACTONE, ETIZOLAM, WARFARIN, VERAPAMIL, ENALAPRIL. Patient was hospitalized and became disabled. Patient recovered.

Amiodarone Side Effects Report #5082569-X
AMIODARONE problem was reported by a Physician from UNITED STATES on Aug 03, 2006. Male patient, 53 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, blood glucose increased, blood thyroid stimulating hormone decreased, bundle branch block right, cardiomegaly, dizziness, dyspnoea, electrocardiogram st segment depression, fatigue. AMIODARONE dosage: unknown. During the same period patient was treated with DILTIAZEM, DIGOXIN, IRBESARTAN, FUROSEMIDE, CARVEDILOL. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5083376-4
Pharmacist from UNITED STATES reported AMIODARONE problem on Aug 16, 2006. Female patient, 77 years of age, weighting 219.6 lb, was diagnosed with ventricular tachyarrhythmia and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: cardiac failure congestive, chronic obstructive pulmonary disease, hypothyroidism, hypoxia, pyrexia. AMIODARONE dosage: 200 MG PO DAILY. During the same period patient was treated with BUMEX, PLAVIX, PROTONIX, SPIRIVA, ALBUTEROL SPIROS, COREG, POTASSIUM CHLORIDE, COUMADIN. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5085199-9
AMIODARONE problem was reported by a Physician from UNITED STATES on Aug 04, 2006. Male patient, 67 years of age, was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident, optic neuropathy. AMIODARONE dosage: 200 MG. Patient died.

Amiodarone Side Effects Report #5085202-6
Physician from UNITED STATES reported AMIODARONE problem on Aug 04, 2006. Male patient, 70 years of age, was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: myocardial infarction, optic neuropathy, papilloedema. AMIODARONE dosage: unknown. Patient died.

Amiodarone Side Effects Report #5085206-3
AMIODARONE problem was reported by a Physician from UNITED STATES on Aug 04, 2006. Male patient, 79 years of age, was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: meningitis, optic neuropathy, papilloedema. AMIODARONE dosage: 200 MG. Patient died.

Amiodarone Side Effects Report #5086071-0
Consumer or non-health professional from UNITED KINGDOM reported AMIODARONE problem on Aug 07, 2006. Male patient, 74 years of age, was diagnosed with myocardial infarction and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: corneal deposits, keratopathy. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5087977-9
AMIODARONE problem was reported by a Pharmacist from UNITED STATES on Aug 23, 2006. Female patient, 77 years of age, weighting 219.6 lb, was diagnosed with ventricular tachycardia and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: cardiac failure congestive, chronic obstructive pulmonary disease, hyperthyroidism, hypoxia, pneumonia, pyrexia. AMIODARONE dosage: 200 MG PO DAILY. During the same period patient was treated with BUMEX, PLAVIX, PROTONIX, SPIRIVA, ALBUTEROL, COREG, KCL PO, COUMADIN. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5088970-2
Consumer or non-health professional from UNITED STATES reported AMIODARONE problem on Aug 24, 2006. Male patient, weighting 136.0 lb, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: cardiac pacemaker insertion, pulmonary fibrosis. AMIODARONE dosage: 200 MG DAILY PO. Patient was hospitalized and became disabled. Patient recovered.

Amiodarone Side Effects Report #5090637-1
AMIODARONE problem was reported by a Physician from UNITED STATES on Aug 14, 2006. Male patient, 72 years of age, weighting 170.2 lb, was diagnosed with arrhythmia, coronary artery bypass, diabetes mellitus, hyperlipidaemia and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: azotaemia, hepatotoxicity, renal failure, rhabdomyolysis. AMIODARONE dosage: 200 MG DAILY. During the same period patient was treated with SIMVASTATIN, METFORMIN, ENALAPRIL, GLIMEPIRIDE, HYDROCHLOROTHIAZIDE, ASPIRIN. Patient recovered.

Amiodarone Side Effects Report #5090822-9
Consumer or non-health professional from UNITED KINGDOM reported AMIODARONE problem on Aug 11, 2006. Male patient, 56 years of age, was diagnosed with supraventricular tachycardia and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, blood creatine phosphokinase increased, liver function test abnormal, movement disorder, myositis. AMIODARONE dosage: unknown. During the same period patient was treated with CLARITHROMYCIN, SIMVASTATIN, ASPIRIN, CEFTRIAXONE, FERROUS SULPHATE, LANSOPRAZOLE, ADENOSINE. Patient recovered.

Amiodarone Side Effects Report #5091511-7
AMIODARONE problem was reported by a Physician from UNITED STATES on Aug 11, 2006. Male patient, 69 years of age, was diagnosed with arrhythmia and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: asthenia, cardiac murmur, cough, crepitations, pulmonary alveolar haemorrhage, weight decreased. AMIODARONE dosage: 200 MG;QD;PO. During the same period patient was treated with ASPIRIN, LANSOPRAZOLE, LEVOTHYROXINE, METHOCARBAMOL, METOPROLOL TARTRATE, OXYCODONE, RISPERIDONE. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5092083-3
Physician from JAPAN reported AMIODARONE problem on Aug 14, 2006. Male patient, 69 years of age, was diagnosed with arrhythmogenic right ventricular dysplasia and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: anti-thyroid antibody, autoimmune disorder, blood immunoglobulin a increased, blood immunoglobulin g decreased, hyperthyroidism, hypothyroidism, multiple myeloma, normochromic normocytic anaemia. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5092086-9
AMIODARONE problem was reported by a Health Professional from UNITED KINGDOM on Aug 15, 2006. Male patient was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, blood pressure decreased, erythema, vasodilatation. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5093402-4
Consumer or non-health professional from UNITED KINGDOM reported AMIODARONE problem on Jan 04, 2005. Male patient, 56 years of age, weighting 172.0 lb, was diagnosed with supraventricular tachycardia, blood cholesterol increased, lower respiratory tract infection and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, hypokalaemia, hypokinesia, infection, liver function test abnormal, mobility decreased, muscular weakness. AMIODARONE dosage: unknown. During the same period patient was treated with SIMVASTATIN, CLARITHROMYCIN, AMLODIPINE, LANSOPRAZOLE, FERROUS SULPHATE ANHYDROUS. Patient was hospitalized and became disabled. Patient recovered.

Amiodarone Side Effects Report #5093613-8
AMIODARONE problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 11, 2006. Female patient was diagnosed with cardiac disorder and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: asthenia, cardiac failure, dialysis, diarrhoea, duodenal ulcer haemorrhage, feeling abnormal, hepatic failure, liver transplant. AMIODARONE dosage: 200 MG, QD, PO. During the same period patient was treated with LANOXIN. Patient was hospitalized. Patient died on 04/27/2005.

Amiodarone Side Effects Report #5094352-X
Consumer or non-health professional from UNITED KINGDOM reported AMIODARONE problem on Aug 16, 2006. Female patient, 72 years of age, weighting 165.3 lb, was diagnosed with atrial fibrillation, hypertension and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: ischaemia, vasculitis. AMIODARONE dosage: 100 MG, ORAL. During the same period patient was treated with PERINDOPRIL ERBUMINE, ASPIRIN, FUROSEMIDE, LERCANIDIPINE, SIMVASTATIN, WARFARIN. Patient recovered.

Amiodarone Side Effects Report #5095415-5
AMIODARONE problem was reported by a Pharmacist from UNITED STATES on Aug 18, 2006. Female patient was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: prothrombin time prolonged. AMIODARONE dosage: unknown. During the same period patient was treated with FUROSEMIDE, INSULIN, MAGNESIUM OXIDE, MORPHINE, NITROGLYCERIN, PROTONIX, PARXETINE. Patient recovered.

Amiodarone Side Effects Report #5095524-0
Pharmacist from UNITED STATES reported AMIODARONE problem on Aug 31, 2006. Male patient, 70 years of age, weighting 204.0 lb, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: post procedural complication, procedural hypotension, pulmonary oedema. AMIODARONE dosage: 75 MG IV X 1. During the same period patient was treated with LOPID, ALLOPURINOL, FUROSEMIDE, COZAAR, EROTRIN, VITAMIN, HEPARIN, BICARB. Patient was hospitalized. Patient died on 03/30/2006.

Amiodarone Side Effects Report #5096649-6
AMIODARONE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Aug 24, 2006. Female patient, 72 years of age, was diagnosed with atrial fibrillation, hypertension and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: peripheral ischaemia, vasculitis. AMIODARONE dosage: 100 MG TABLET. During the same period patient was treated with PERINDOPRIL ERBUMINE, ASPIRIN, FUROSEMIDE, LERCANIDIPINE, SIMVASTATIN, WARFARIN. Patient recovered.

Amiodarone Side Effects Report #5096682-4
Consumer or non-health professional from SPAIN reported AMIODARONE problem on Aug 15, 2006. Female patient, 85 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: asthenia, cardiac failure congestive, cardiomegaly, hypothyroidism, pericardial effusion, pleural effusion, pulmonary hypertension, renal impairment, respiratory failure. AMIODARONE dosage: unknown. During the same period patient was treated with LEVOTHYROXINE. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5097473-0
AMIODARONE problem was reported by a Consumer or non-health professional from UNITED STATES on June 22, 2006. Female patient, 85 years of age, weighting 130.0 lb, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: anorexia, dyspnoea, weight decreased, weight fluctuation. AMIODARONE dosage: 200MG, QD, ORAL. During the same period patient was treated with TOPROL, WARFARIN, DIGITEK, ENSURE. Patient recovered.

Amiodarone Side Effects Report #5097852-1
Consumer or non-health professional from UNITED KINGDOM reported AMIODARONE problem on Aug 23, 2006. Male patient, weighting 176.4 lb, was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: hypothyroidism, pulmonary fibrosis, respiratory failure. AMIODARONE dosage: unknown. During the same period patient was treated with WARFARIN, DESLORATADINE, DILTIAZEM, LANSOPRAZOLE, MONOMAX, NAPROXEN, SULFASALAZINE, SERETIDE. Patient died on 09/07/2005.

Amiodarone Side Effects Report #5097951-4
AMIODARONE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Aug 23, 2006. Male patient was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: acute myocardial infarction, left ventricular failure, pneumonia, pneumonitis. AMIODARONE dosage: unknown. During the same period patient was treated with ALLOPURINOL, AMLODIPINE, ASPIRIN, ATORVASTATIN CALCIUM, BISOPROLOL FUMARATE, OMACOR, RAMIPRIL. Patient died on 04/19/2006.

Amiodarone Side Effects Report #5100572-8
Pharmacist from UNITED STATES reported AMIODARONE problem on Sept 07, 2006. Male patient, 72 years of age, was diagnosed with atrial fibrillation, hyperlipidaemia and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: bone pain, dialysis, renal failure acute, rhabdomyolysis. AMIODARONE dosage: 200 MG QD AM PO. During the same period patient was treated with SIMVASTATIN. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5100764-8
AMIODARONE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Aug 22, 2006. Male patient, 76 years of age, weighting 172.0 lb, was diagnosed with atrial flutter and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: chest discomfort, erythema, hypertension, hypotension, respiratory arrest, tachycardia. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5102735-4
Consumer or non-health professional from UNITED KINGDOM reported AMIODARONE problem on Aug 23, 2006. Male patient was diagnosed with gout and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: acute myocardial infarction, left ventricular failure, pneumonia, pneumonitis. AMIODARONE dosage: unknown. Patient died.

Amiodarone Side Effects Report #5103084-0
AMIODARONE problem was reported by a Consumer or non-health professional from PUERTO RICO on Aug 27, 2006. Female patient, 40 years of age, was diagnosed with congestive cardiomyopathy and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: heart transplant, hyperthyroidism. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5103253-X
Health Professional from UNITED KINGDOM reported AMIODARONE problem on Aug 31, 2006. Male patient, 76 years of age, was diagnosed with arrhythmia, atrial flutter and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: chest discomfort, erythema, hypertension, hypotension, respiratory arrest, tachycardia. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5104294-9
AMIODARONE problem was reported by a Pharmacist from UNITED STATES on Sept 12, 2006. Female patient, 77 years of age, weighting 107.8 lb, was diagnosed with arrhythmia and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: bradyarrhythmia. AMIODARONE dosage: 900MG BAG CONTINUOUS IV DRIP. Patient recovered.

Amiodarone Side Effects Report #5106899-8
Health Professional from UNITED KINGDOM reported AMIODARONE problem on Sept 06, 2006. Male patient was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: acute myocardial infarction, left ventricular failure, pneumonitis. AMIODARONE dosage: unknown. During the same period patient was treated with ALLOPURINOL, AMLODIPINE, ASPIRIN, ATORVASTATIN CALCIUM, BISOPROLOL FUMARATE, OMACOR, RAMIPRIL, SERETIDE. Patient died.

Amiodarone Side Effects Report #5107312-7
AMIODARONE problem was reported by a Health Professional from POLAND on Sept 07, 2006. Female patient, 23 years of age, was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, dermatitis allergic, hypersensitivity, infusion related reaction, skin reaction. AMIODARONE dosage: 150 MG 1X PER 1 DAY. Patient recovered.

Amiodarone Side Effects Report #5110635-9
Consumer or non-health professional from UNITED STATES reported AMIODARONE problem on Sept 01, 2006. Male patient, 62 years of age, was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: cardiac pacemaker insertion, implantable defibrillator insertion, optic atrophy, optic ischaemic neuropathy, optic nerve cupping, retinal pigment epitheliopathy. AMIODARONE dosage: 1200 MG QD. Patient recovered.

Amiodarone Side Effects Report #5113463-3
AMIODARONE problem was reported by a Consumer or non-health professional from BELGIUM on Sept 12, 2006. Male patient, 80 years of age, was diagnosed with atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: injection site erythema, injection site haematoma, injection site thrombosis, injection site warmth. AMIODARONE dosage: unknown. Patient recovered.

Amiodarone Side Effects Report #5114522-1
Physician from UNITED KINGDOM reported AMIODARONE problem on Sept 12, 2006. Female patient, 85 years of age, was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: cardiac failure. AMIODARONE dosage: unknown. During the same period patient was treated with LETROZOLE. Patient was hospitalized. Patient recovered.

Amiodarone Side Effects Report #5114716-5
AMIODARONE problem was reported by a Health Professional from UNITED STATES on Sept 22, 2006. Male patient, 66 years of age, weighting 220.0 lb, was diagnosed with arrhythmia, atrial fibrillation and was treated with AMIODARONE. After drug was administered, patient experienced the following problems/side effects: affective disorder, angina pectoris, blood pressure immeasurable, cardiac arrest, cardiac failure congestive, collapse of lung, dialysis, interstitial lung disease, ocular icterus. AMIODARONE dosage: 200MG? DAILY PO. During the same period patient was treated with ANTIDEPRESSANT. Patient was hospitalized and became disabled. Patient died on 04/18/2005.

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Drug Information: Amiodarone Oral

URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a687009.html

(a mee' oh da rone)

IMPORTANT WARNING:

Amiodarone may cause lung disease that can be serious or life-threatening.Tell your doctor if you have or have ever had any type of lung disease. If you experience any of the following symptoms, call your doctor immediately: fever, shortness of breath, wheezing, cough, coughing up blood, and any other breathing problems. Amiodarone also may cause liver disease. Tell your doctor if you have or have ever had liver disease. If your experience any of the following symptoms, call your doctor immediately: upset stomach, vomiting, dark colored urine, excessive tiredness, yellowing of the skin or eyes, itching, or pain in the upper right part of the stomach.Amiodarone may cause your irregular heart rhythm (arrhythmia) to worsen or may cause you to develop new arrhythmias. Tell your doctor if you have ever been dizzy or lightheaded or have fainted because your heartbeat was too slow and if you have or have ever had low levels of potassium in your blood; heart or thyroid disease; or any problems with your heart rhythm other than the irregular heartbeat being treated. Tell your doctor and pharmacist if you are taking any of the following medications: antifungals such as fluconazole (Diflucan), ketoconazole (Nizoral), and itraconazole (Sporanox); azithromycin (Zithromax); beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac, others), felodipine (Plendil), isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat, Procardia), nimodipine (Nimotop), nisoldipine (Sular), and verapamil (Calan, Covera, Isoptin, Verelan); cisapride (Propulsid); clarithromycin (Biaxin); diuretics ('water pills'); dofetilide (Tikosyn); erythromycin (E.E.S., E-Mycin, Erythrocin); fluoroquinolone antibiotics such as ciprofloxacin (Cipro), gatifloxacin (Tequin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and sparfloxacin (Zagam); other medications for irregular heartbeat such as digoxin (Lanoxin), disopyramide (Norpace), flecainide (Tambocor), phenytoin (Dilantin), procainamide (Procanbid, Pronestyl), quinidine (Quinidex) and sotalol (Betapace); and thioridazine (Mellaril). If you have any of the following symptoms, call your doctor immediately: lightheadedness; fainting; fast, slow, or pounding heartbeat; or feeling that your heart has skipped a beat.You will probably be hospitalized for one week or longer when you begin your treatment with amiodarone. Your doctor will monitor you carefully during this time and for as long as you continue to take amiodarone. Your doctor will probably start you on a high dose of amiodarone and gradually decrease your dose as the medication begins to work. Your doctor may decrease your dose during your treatment if you develop side effects. Follow your doctor's directions carefully.Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests, such as blood tests, X-rays, and electrocardiograms (EKGs, tests that record the electrical activity of the heart) before and during your treatment to be sure that it is safe for you to take amiodarone and to check your body's response to the medication.Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with amiodarone and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions.You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/medwatch/SAFETY/2005/Cordarone_Med_Guide.pdf.Talk to your doctor about the risks of taking amiodarone.

Why is this medication prescribed?

Amiodarone is used to treat and prevent certain types of ventricular arrhythmias (abnormal heart rhythm). Amiodarone is in a class of medications called antiarrhythmics. It works by relaxing overactive heart muscles.

How should this medicine be used?

Amiodarone comes as a tablet to take by mouth. It is usually taken once or twice a day. Your doctor will tell you to take amiodarone with or without food; be sure to take it the same way each time. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take amiodarone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Amiodarone controls arrhythmias but does not cure them. Continue to take amiodarone even if you feel well. Do not stop taking amiodarone without talking to your doctor. If you suddenly stop taking amiodarone, your condition may get worse.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking amiodarone,

  • tell your doctor and pharmacist if you are allergic to amiodarone, iodine, any other drugs, or corn.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention the medications listed in the IMPORTANT WARNING and any of the following: antidepressants ('mood elevators') such as fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), nefazodone (Serzone); anticoagulants ('blood thinners') such as warfarin (coumadin); cholesterol lowering medications such as atorvastatin (Lipitor), cholestyramine (Questran), lovastatin (Mevacor), simvastatin (Zocor); cimetidine (Tagamet); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delavirdine (Rescriptor); dextromethorphan (a medication in many cough preparations); dexamethasone (Decadron); fentanyl (Actiq, Duragesic); HIV protease inhibitors such as indinavir (Crixivan), and ritonavir (Norvir); isoniazid (INH, Nydrazid); medications for diabetes; medications for pain; medications for seizures such as carbamazepine (Tegretol), ethosuximide (Zarontin), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin); metronidazole (Flagyl); methotrexate (Rheumatrex); oral contraceptives (birth control pills); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); troglitazone (Rezulin); troleandomycin (TAO); and zafirlukast (Accolate). Your doctor may have to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor what herbal products you are taking, especially St. John's wort.
  • tell your doctor if you have or have ever had problems with your blood pressure.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should use a reliable method of birth control to prevent pregnancy while you are taking amiodarone. If you become pregnant while taking amiodarone, call your doctor immediately. You should not breastfeed while you are taking amiodarone. Talk to your doctor if you plan to become pregnant or breastfeed during the first several months after your treatment because amiordarone may remain in your body for some time after you stop taking it.
  • if you are having surgery, including dental surgery, tell your doctor or dentist that you are taking amiodarone.
  • plan to avoid unnecessary or prolonged exposure to sunlight or sunlamps and to wear protective clothing, sunglasses, and sunscreen. Amiodarone may make your skin sensitive to sunlight. Exposed skin may turn blue-gray and may not return to normal even after you stop using this medication.
  • you should know that amiodarone may cause vision problems including permanent blindness. Be sure to have regular eye exams during your treatment and call your doctor if you have any changes with your eyes or notice any changes in your vision.
  • you should know that amiodarone may remain in your body for several months after your stop taking it. You may continue to experience side effects of amiodarone during this time. Be sure to tell your health care provider who treats you or prescribes any medication for you during this time that you have recently stopped taking amiodarone.

What special dietary instructions should I follow?

Do not drink grapefruit juice while taking this medication.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Amiodarone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • vomiting
  • constipation
  • headache
  • decreased sex drive
  • difficulty falling asleep or staying asleep
  • flushing
  • dry eyes
  • changes in ability to taste and smell
  • changes in amount of saliva

Some side effects can be serious. If you experience any of the following symptoms, or those listed in the IMPORTANT WARNING section, call your doctor immediately:

  • rash
  • weight loss or gain
  • restlessness
  • intolerance to heat or cold
  • thinning hair
  • excessive sweating
  • changes in menstrual cycle
  • swelling in the front of the neck (goiter)
  • decreased vision or changes in your ability to see such as blurred vision or seeing halos
  • eyes are sensitive to light
  • eye pain
  • swelling of the hands, feet, ankles, or lower legs
  • shaking hands that you can not control
  • movements that you can not control
  • poor coordination or trouble walking
  • numbness or tingling in the hands, legs, and feet
  • muscle weakness

Laboratory animals who were given amiodarone developed thyroid tumors. It is not known if amiodarone increases the risk of developing thyroid tumors in humans.

Talk to your doctor about the risk of taking amiodarone.

Amiodarone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Protect this medication from light. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

  • slow heartbeat
  • upset stomach
  • blurred vision
  • lightheadedness
  • fainting

What other information should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand name(s):

  • Cordarone®
  • Pacerone®

Ask Our Patient Community about Amiodarone

PatientsVille.com does not provide medical advice, diagnosis or treatment. The information contained on PatientsVille.com site has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of adverse drug reactions or for establishing or changing of patient treatments.


Thank you for visiting Patientsville.com. We hope you found our information about prescription drug side effects helpful. The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. Thank you for visiting Patientsville.net. Hope you enjoyed finding Amiodarone safety information and found answers to Your Questions about Amiodarone side effects

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