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Coversyl Side Effects submitted to FDA

Total Coversyl reports: 23.
Coversyl FDA safety alerts: No.
Reported deaths: 2    Reported hospitalizations: 20.
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FDA Reported Coversyl Side Effects: renal failure acute, orthopnoea, left ventricular failure, dyspnoea, cough, lung disorder, hyperkalaemia, hyponatraemia, confusional state, orthostatic hypotension, fall,
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Coversyl Side Effects Report #5654640-2
Consumer or non-health professional from CANADA reported COVERSYL problem on Feb 28, 2008. Male patient, 50 years of age, was diagnosed with hypertension and was treated with COVERSYL. After drug was administered, patient experienced the following problems/side effects: anxiety, balance disorder, confusional state, incoherent, memory impairment. COVERSYL dosage: DAILY DOSE: 8 MILLIGRAM(S). Patient recovered.



Coversyl Side Effects Report #5670547-9
COVERSYL problem was reported by a Health Professional from UNITED KINGDOM on Mar 10, 2008. Male patient was diagnosed with hypertension and was treated with COVERSYL. After drug was administered, patient experienced the following problems/side effects: conjunctivitis, dry eye, retinal detachment, vitreous detachment. COVERSYL dosage: DAILY DOSE: 2 MILLIGRAM(S). Patient recovered.



Coversyl Side Effects Report #5605903-8
Health Professional from FRANCE reported COVERSYL problem on Jan 15, 2008. Female patient, 81 years of age, was diagnosed with hypertension and was treated with COVERSYL. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, conjunctival hyperaemia, convulsion, eczema, hallucination. COVERSYL dosage: DAILY DOSE: 4 MILLIGRAM(S). During the same period patient was treated with LOSARTAN POTASSIUM. Patient was hospitalized. Patient recovered.



Coversyl Side Effects Report #5537007-7
COVERSYL problem was reported by a Health Professional from FRANCE on Nov 30, 2007. Male patient, 46 years of age, was diagnosed with ill-defined disorder and was treated with COVERSYL. After drug was administered, patient experienced the following problems/side effects: eczema. COVERSYL dosage: unknown. During the same period patient was treated with LASILIX, BEFIZAL, TAREG. Patient was hospitalized. Patient recovered.




Coversyl Side Effects Report #5554824-8
Health Professional from FRANCE reported COVERSYL problem on Nov 30, 2007. Male patient, 79 years of age, was diagnosed with hypertension, ill-defined disorder and was treated with COVERSYL. After drug was administered, patient experienced the following problems/side effects: angioedema, dysphagia, dyspnoea, prostate cancer, scrotal oedema. COVERSYL dosage: DAILY DOSE: 4 MILLIGRAM(S). During the same period patient was treated with DECAPEPTYL, FENOFIBRATE, OLMETEC, KARDEGIC, LEXOMIL. Patient was hospitalized. Patient recovered.



Coversyl Side Effects Report #5568215-7
COVERSYL problem was reported by a Consumer or non-health professional from ITALY on Dec 06, 2007. Female patient, 65 years of age, was diagnosed with hypertension and was treated with COVERSYL. After drug was administered, patient experienced the following problems/side effects: dizziness, loss of consciousness. COVERSYL dosage: DAILY DOSE: 4 MILLIGRAM(S). Patient recovered.



Coversyl Side Effects Report #5571508-0
Physician from UNITED KINGDOM reported COVERSYL problem on Nov 21, 2007. Female patient, 66 years of age, was diagnosed with hypertension and was treated with COVERSYL. After drug was administered, patient experienced the following problems/side effects: acidosis, anaphylactoid reaction, cardiac arrest, renal failure, septic shock. COVERSYL dosage: unknown. Patient was hospitalized. Patient recovered.



Coversyl Side Effects Report #5503763-7
COVERSYL problem was reported by a Consumer or non-health professional from CANADA on Oct 22, 2007. Male patient was diagnosed with hypertension and was treated with COVERSYL. After drug was administered, patient experienced the following problems/side effects: muscular weakness, myalgia. COVERSYL dosage: DAILY DOSE: 4 MILLIGRAM(S). Patient recovered.



Coversyl Side Effects Report #5520584-X
Consumer or non-health professional from UNITED KINGDOM reported COVERSYL problem on Nov 13, 2007. Male patient, 43 years of age, was diagnosed with ill-defined disorder and was treated with COVERSYL. After drug was administered, patient experienced the following problems/side effects: hypokalaemia, hypotension, intentional overdose, metabolic acidosis, renal failure, urinary retention. COVERSYL dosage: DAILY DOSE: 120 MILLIGRAM(S). During the same period patient was treated with AMLODIPINE, FLUOXETINE, FOLIC ACID, ACETYLSALICYLIC ACID SRT, PARACETAMOL, CITALOPRAM. Patient was hospitalized. Patient recovered.




Coversyl Side Effects Report #5521708-0
COVERSYL problem was reported by a Physician from NETHERLANDS on Nov 12, 2007. Male patient, 80 years of age, was diagnosed with hypertension and was treated with COVERSYL. After drug was administered, patient experienced the following problems/side effects: angina pectoris. COVERSYL dosage: DAILY DOSE: 4 MILLIGRAM(S). Patient was hospitalized. Patient recovered.



Coversyl Side Effects Report #5528785-1
Physician from UNITED KINGDOM reported COVERSYL problem on Nov 19, 2007. Female patient, 66 years of age, was diagnosed with ill-defined disorder and was treated with COVERSYL. After drug was administered, patient experienced the following problems/side effects: acidosis, anaphylactoid reaction, cardiac arrest, renal failure, septic shock. COVERSYL dosage: unknown. Patient was hospitalized. Patient recovered.



Coversyl Side Effects Report #5445956-3
COVERSYL problem was reported by a Health Professional from FRANCE on Aug 28, 2007. Male patient, 79 years of age, was diagnosed with ill-defined disorder and was treated with COVERSYL. After drug was administered, patient experienced the following problems/side effects: haemodynamic instability, hyperkalaemia, lung disorder, multi-organ failure, orthopnoea, pleural effusion, pneumonitis, renal failure acute. COVERSYL dosage: DAILY DOSE: 2 MILLIGRAM(S). During the same period patient was treated with AMIODARONE, DIGOXIN, PLAVIX. Patient was hospitalized. Patient died on 07/15/2007.



Coversyl Side Effects Report #5448636-3
Health Professional from FRANCE reported COVERSYL problem on Aug 31, 2007. Female patient, 75 years of age, was diagnosed with hypertension, ill-defined disorder, osteoporosis, hypothyroidism, peripheral arterial occlusive disease and was treated with COVERSYL. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. COVERSYL dosage: DAILY DOSE: 2 MILLIGRAM(S). During the same period patient was treated with CALCIDOSE, ZOMETA, POTASSIUM CHLORIDE, KREDEX, TARDYFERON, AROMASIN, LEVOTHYROX, PLAVIX. Patient recovered.



Coversyl Side Effects Report #5453638-7
COVERSYL problem was reported by a Health Professional from FRANCE on Sept 11, 2007. Female patient was diagnosed with hypertension, type 2 diabetes mellitus, pain, ill-defined disorder, thrombosis prophylaxis, depression and was treated with COVERSYL. After drug was administered, patient experienced the following problems/side effects: anorexia, diabetes mellitus inadequate control, somnolence. COVERSYL dosage: DAILY DOSE: 2 MILLIGRAM(S). During the same period patient was treated with DIAMICRON, DURAGESIC, CORDIPATCH, MINISINTROM, DEROXAT, MOPRAL. Patient was hospitalized. Patient recovered.




Coversyl Side Effects Report #5405386-7
Health Professional from AUSTRALIA reported COVERSYL problem on Jan 04, 2007. Male patient, weighting 176.4 lb, was diagnosed with essential hypertension, cardiac failure congestive and was treated with COVERSYL. After drug was administered, patient experienced the following problems/side effects: acidosis, diarrhoea, hypotension, oliguria, oral intake reduced, renal failure acute. COVERSYL dosage: DAILY DOSE: 4 MILLIGRAM(S). During the same period patient was treated with FRUSEMIDE. Patient was hospitalized. Patient recovered.



Coversyl Side Effects Report #5405684-7
COVERSYL problem was reported by a Physician from MALTA on July 26, 2007. Female patient, 50 years of age, weighting 176.4 lb, was diagnosed with hyperlipidaemia and was treated with COVERSYL. After drug was administered, patient experienced the following problems/side effects: blood calcium increased, dry mouth, muscular weakness, myalgia, pain in jaw, paraesthesia, trismus. COVERSYL dosage: unknown. During the same period patient was treated with BURINEX, ZOMIG, LESCOL, ATORVASTATIN CALCIUM. Patient recovered.



Coversyl Side Effects Report #5414987-1
Health Professional from FRANCE reported COVERSYL problem on Aug 06, 2007. Male patient was diagnosed with ill-defined disorder and was treated with COVERSYL. After drug was administered, patient experienced the following problems/side effects: proctitis, prostate cancer, rectal haemorrhage. COVERSYL dosage: DAILY DOSE: 4 MILLIGRAM(S). During the same period patient was treated with PREVISCAN, KARDEGIC, ELISOR, ANAFRANIL, ATENOLOL, ZOPICLONE. Patient was hospitalized. Patient recovered.



Coversyl Side Effects Report #5419731-X
COVERSYL problem was reported by a Health Professional from NETHERLANDS on Aug 01, 2007. Female patient, 48 years of age, was diagnosed with ill-defined disorder and was treated with COVERSYL. After drug was administered, patient experienced the following problems/side effects: cough, disorientation, dyspnoea, wheezing. COVERSYL dosage: DAILY DOSE: 4 MILLIGRAM(S). During the same period patient was treated with CRESTOR, ASCAL CARDIO, BECLOMETHASONE DIPROPIONATE. Patient recovered.



Coversyl Side Effects Report #5386223-6
Consumer or non-health professional from FRANCE reported COVERSYL problem on July 03, 2007. Female patient was diagnosed with hypercholesterolaemia and was treated with COVERSYL. After drug was administered, patient experienced the following problems/side effects: arthralgia, dizziness, headache, hot flush, ligament rupture, malaise, pituitary tumour benign, surgery, tendonitis. COVERSYL dosage: 4 MG, BID. During the same period patient was treated with LEVOTHYROXINE, PREVISCAN, DOSTINEX, LESCOL. Patient was hospitalized. Patient recovered.




Coversyl Side Effects Report #5386223-6
COVERSYL problem was reported by a Consumer or non-health professional from FRANCE on July 03, 2007. Female patient was diagnosed with hypercholesterolaemia and was treated with COVERSYL. After drug was administered, patient experienced the following problems/side effects: arthralgia, dizziness, headache, hot flush, ligament rupture, malaise, pituitary tumour benign, surgery, tendonitis. COVERSYL dosage: 4 MG, BID. During the same period patient was treated with LEVOTHYROXINE, PREVISCAN, DOSTINEX, LESCOL. Patient was hospitalized. Patient recovered.



Coversyl Side Effects Report #5706883-7
Health Professional from FRANCE reported COVERSYL problem on Apr 07, 2008. Female patient was diagnosed with hypertension and was treated with COVERSYL. After drug was administered, patient experienced the following problems/side effects: candiduria, fall, renal failure. COVERSYL dosage: DAILY DOSE: 2 MILLIGRAM(S). During the same period patient was treated with ISOPTIN, LASILIX, DUPHALAC, DIANTALVIC, KARDEGIC, COUMADIN. Patient was hospitalized. Patient recovered.



Coversyl Side Effects Report #5706884-9
COVERSYL problem was reported by a Physician from BELGIUM on Apr 03, 2008. Female patient, weighting 132.3 lb, was diagnosed with hypertension and was treated with COVERSYL. After drug was administered, patient experienced the following problems/side effects: toxic skin eruption. COVERSYL dosage: unknown. During the same period patient was treated with ALLOPURINOL, CORTICOSTEROIDS. Patient was hospitalized. Patient recovered.



Coversyl Side Effects Report #5334973-X
Physician from IRELAND reported COVERSYL problem on Mar 13, 2007. Male patient, weighting 160.9 lb, was diagnosed with blood pressure increased and was treated with COVERSYL. After drug was administered, patient experienced the following problems/side effects: acute hepatic failure, epstein-barr virus infection, pancreatitis, pancytopenia. COVERSYL dosage: DAILY DOSE: UNIT DOSE: 4 MG/1.25 MG TABLETS. Patient was hospitalized. Patient died on 10/04/2006.




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