Flolan Side Effects
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Flolan Safety Reports reported to FDA
Total Flolan reports: 234.Flolan FDA safety alerts: No.
Reported deaths: 39 Reported hospitalizations: 58.
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Reported Flolan Side Effects: catheter related complication, death, pulmonary hypertension, catheter related infection, pulmonary haemorrhage, headache, nausea, pulmonary oedema, dyspnoea, diarrhoea, hyperthyroidism.
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Flolan Side Effects Report #5123276-4Physician from JAPAN reported FLOLAN problem on Sept 14, 2006. Male patient, child 4 years of age, was diagnosed with pulmonary hypertension and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: haemoptysis, pulmonary haemorrhage. FLOLAN dosage: unknown. During the same period patient was treated with WARFARIN, TRACLEER, VIAGRA. Patient was hospitalized. Patient recovered.
Flolan Side Effects Report #5123278-8
FLOLAN problem was reported by a Physician from JAPAN on Sept 14, 2006. Female patient, child 7 years of age, weighting 33.07 lb, was diagnosed with pulmonary hypertension, sedation and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: bradycardia, c-reactive protein increased, cough, hypoxia, oxygen saturation decreased, pyrexia. FLOLAN dosage: unknown. During the same period patient was treated with ASPIRIN, CAPTOPRIL, MORPHINE, LANIRAPID, LASIX, NEUER, NIFEDIPINE, DORNER. Patient died on 04/24/2006.
Flolan Side Effects Report #5127719-1
Physician from JAPAN reported FLOLAN problem on Sept 20, 2006. Male patient, 13 years of age, was diagnosed with pulmonary hypertension and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: atelectasis, haemoptysis, pulmonary artery aneurysm, pulmonary haemorrhage, syncope. FLOLAN dosage: unknown. During the same period patient was treated with SILDENAFIL CITRATE, BUFFERIN, DIOVAN. Patient died on 04/07/2005.
Flolan Side Effects Report #5130498-5
FLOLAN problem was reported by a Physician from JAPAN on Sept 20, 2006. Male patient, 13 years of age, was diagnosed with pulmonary hypertension and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: atelectasis, haemoptysis, pulmonary artery aneurysm, pulmonary haemorrhage, syncope. FLOLAN dosage: unknown. During the same period patient was treated with SILDENAFIL CITRATE, BUFFERIN, DIOVAN. Patient died on 04/07/2005.
Flolan Side Effects Report #5139466-0
Physician from UNITED STATES reported FLOLAN problem on Oct 26, 2006. Male patient, 63 years of age, weighting 186.0 lb, was diagnosed with pulmonary hypertension and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: blood culture positive, central line infection, dyspnoea, fatigue, pseudomonas infection. FLOLAN dosage: unknown. During the same period patient was treated with CALCIUM, COUMADIN, FASOMAX, LIPITOR, LOMOTIL, NORVASC, ZYRITEC, DIGOXIN. Patient recovered.
Flolan Side Effects Report #5152167-8
FLOLAN problem was reported by a Pharmacist from JAPAN on Aug 29, 2006. Male patient, 64 years of age, weighting 138.9 lb, was diagnosed with pulmonary hypertension and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: blister, epidermolysis, erythema multiforme, stevens-johnson syndrome, toxic epidermal necrolysis. FLOLAN dosage: .5MG PER DAY. During the same period patient was treated with PROPOFOL, HEPARIN, BIOFERMIN, SERENACE, INTRALIPID, P N TWIN, NEOLAMIN. Patient was hospitalized. Patient recovered.
Flolan Side Effects Report #5153112-1
Consumer or non-health professional from UNITED STATES reported FLOLAN problem on Nov 13, 2006. Female patient, 70 years of age, was diagnosed with pulmonary hypertension and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: anaemia, asthenia, dehydration, diarrhoea, disease progression, dyspnoea. FLOLAN dosage: unknown. During the same period patient was treated with INVESTIGATIONAL COMPOUND, SILDENAFIL CITRATE, NIFEDIPINE, WARFARIN, TORSEMIDE, OXYGEN, OMEPRAZOLE, DEXTROPROPOXYPHEN. Patient was hospitalized. Patient recovered.
Flolan Side Effects Report #5162003-1
FLOLAN problem was reported by a Physician from JAPAN on Nov 06, 2006. Female patient, 35 years of age, was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, bronchitis, cellulitis, enteritis infectious, epistaxis, granulocyte count decreased, pain in jaw, platelet count decreased, pneumonia. FLOLAN dosage: unknown. Patient recovered.
Flolan Side Effects Report #5162164-4
Physician from JAPAN reported FLOLAN problem on Nov 14, 2006. Female patient, 47 years of age, was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: catheter related infection, platelet count decreased, shock. FLOLAN dosage: unknown. Patient recovered.
Flolan Side Effects Report #5164365-8
FLOLAN problem was reported by a Health Professional from UNITED STATES on Nov 29, 2006. Female patient, 39 years of age, weighting 121.3 lb, was diagnosed with pulmonary hypertension and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: dyspnoea exertional, hyperthyroidism, lung consolidation, lung neoplasm, micrococcus infection, septic embolus, syncope, tachycardia. FLOLAN dosage: unknown. During the same period patient was treated with LISINOPRIL, COUMADIN, SILDENAFIL CITRATE, HYDROCHLOROTHIAZIDE, IMODIUM, DIGOXIN, NEURONTIN, RESTORIL. Patient was hospitalized. Patient recovered.
Flolan Side Effects Report #5173159-9
Health Professional from UNITED STATES reported FLOLAN problem on Dec 07, 2006. Female patient, 27 years of age, weighting 209.0 lb, was diagnosed with pulmonary hypertension and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: central line infection, staphylococcal infection. FLOLAN dosage: unknown. During the same period patient was treated with COUMADIN, DIGOXIN, LASIX. Patient was hospitalized. Patient recovered.
Flolan Side Effects Report #5190506-2
FLOLAN problem was reported by a Consumer or non-health professional from JAPAN on Dec 12, 2006. Female patient, 31 years of age, was diagnosed with pulmonary hypertension and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: abortion threatened, dyspnoea. FLOLAN dosage: unknown. Patient was hospitalized. Patient recovered.
Flolan Side Effects Report #5376112-5
Pharmacist from IRELAND reported FLOLAN problem on June 28, 2007. Female patient, child 7 years of age, weighting 44.09 lb, was diagnosed with pulmonary hypertension, vomiting and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: disease progression. FLOLAN dosage: unknown. During the same period patient was treated with TRACLEER, SILDENAFIL CITRATE, ZOFRAN. Patient died on 04/01/2007.
Flolan Side Effects Report #5381989-3
FLOLAN problem was reported by a Consumer or non-health professional from JAPAN on July 02, 2007. Female patient, 44 years of age, weighting 101.4 lb, was diagnosed with pulmonary hypertension, cardiac failure, gastric ulcer, infection and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: hypoxia. FLOLAN dosage: unknown. During the same period patient was treated with BERAPROST, ACARDI, FUROSEMIDE, ALDACTONE, TAKEPRON, CEFAZOLIN, DOBUTREX. Patient recovered.
Flolan Side Effects Report #5381990-X
Consumer or non-health professional from JAPAN reported FLOLAN problem on July 02, 2007. Female patient, 24 years of age, weighting 92.59 lb, was diagnosed with pulmonary hypertension, infection, gastric ulcer, cardiac failure and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: hypoxia. FLOLAN dosage: unknown. During the same period patient was treated with BERAPROST, SEPAMIT, TRACLEER, CEFAMEZIN, ZANTAC, DOPAMINE, DOBUTREX. Patient recovered.
Flolan Side Effects Report #5382008-5
FLOLAN problem was reported by a Physician from SPAIN on July 04, 2007. Male patient, 66 years of age, was diagnosed with diagnostic procedure and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: dizziness, headache, hypertension, hypotension, pneumothorax, pulmonary oedema, respiratory failure. FLOLAN dosage: unknown. During the same period patient was treated with BETA BLOCKERS, NITRATES, DIURETICS. Patient was hospitalized. Patient recovered.
Flolan Side Effects Report #5384206-3
Physician from SPAIN reported FLOLAN problem on July 09, 2007. Male patient, 66 years of age, was diagnosed with diagnostic procedure and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: dizziness, headache, hypotension, pulmonary oedema, respiratory failure. FLOLAN dosage: unknown. During the same period patient was treated with BETA BLOCKERS, NITRATES, DIURETICS. Patient was hospitalized. Patient recovered.
Flolan Side Effects Report #5386562-9
FLOLAN problem was reported by a Consumer or non-health professional from UNITED STATES on July 12, 2007. Female patient, 57 years of age, weighting 143.3 lb, was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: device failure. FLOLAN dosage: unknown. Patient recovered.
Flolan Side Effects Report #5386574-5
Consumer or non-health professional from JAPAN reported FLOLAN problem on July 05, 2007. Female patient, 65 years of age, was diagnosed with pulmonary hypertension and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: pulmonary eosinophilia, pulmonary hypertension, pulmonary oedema, pulmonary vascular disorder. FLOLAN dosage: unknown. During the same period patient was treated with DOBUTAMINE HYDROCHLORIDE. Patient died.
Flolan Side Effects Report #5386590-3
FLOLAN problem was reported by a Physician from JAPAN on July 12, 2007. Female patient, 34 years of age, was diagnosed with pulmonary hypertension and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: basedow's disease, dyspnoea exertional, hyperthyroidism, right ventricular failure. FLOLAN dosage: unknown. During the same period patient was treated with MERCAZOLE. Patient was hospitalized. Patient recovered.
Flolan Side Effects Report #5390087-4
Health Professional from UNITED STATES reported FLOLAN problem on July 17, 2007. Male patient, weighting 130.3 lb, was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: asthenia, catheter related complication, catheter site infection, condition aggravated, procedural complication. FLOLAN dosage: unknown. During the same period patient was treated with ANTIBIOTIC, HEPARIN. Patient was hospitalized and became disabled. Patient recovered.
Flolan Side Effects Report #5392386-9
FLOLAN problem was reported by a Pharmacist from CANADA on July 16, 2007. Female patient, 61 years of age, was treated with FLOLAN. FLOLAN dosage: unknown. Patient died on 07/08/2007.
Flolan Side Effects Report #5400338-5
Health Professional from UNITED STATES reported FLOLAN problem on July 27, 2007. Male patient, weighting 130.3 lb, was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: asthenia, catheter related complication, catheter site infection, condition aggravated, device failure, procedural complication. FLOLAN dosage: unknown. During the same period patient was treated with ANTIBIOTIC, HEPARIN. Patient was hospitalized and became disabled. Patient recovered.
Flolan Side Effects Report #5411225-0
FLOLAN problem was reported by a Physician from JAPAN on Aug 03, 2007. Male patient, 70 years of age, was diagnosed with pulmonary hypertension and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: platelet count decreased. FLOLAN dosage: unknown. During the same period patient was treated with DOBUTAMINE, BOSENTAN. Patient recovered.
Flolan Side Effects Report #5419436-5
Physician from JAPAN reported FLOLAN problem on Aug 16, 2007. Male patient, 70 years of age, was diagnosed with pulmonary hypertension and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: platelet count decreased, viral infection. FLOLAN dosage: unknown. During the same period patient was treated with DOBUTAMINE, BOSENTAN. Patient was hospitalized. Patient recovered.
Flolan Side Effects Report #5424939-3
FLOLAN problem was reported by a Health Professional from UNITED STATES on Aug 20, 2007. Male patient, 50 years of age, weighting 130.3 lb, was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: asthenia, catheter related complication, catheter site infection, condition aggravated, device failure, procedural complication. FLOLAN dosage: unknown. During the same period patient was treated with ANTIBIOTIC, HEPARIN. Patient was hospitalized and became disabled. Patient recovered.
Flolan Side Effects Report #5424968-X
Physician from JAPAN reported FLOLAN problem on Aug 20, 2007. Female patient, 34 years of age, was diagnosed with pulmonary hypertension and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: basedow's disease, dyspnoea exertional, hyperthyroidism, right ventricular failure. FLOLAN dosage: unknown. During the same period patient was treated with MERCAZOLE. Patient was hospitalized. Patient recovered.
Flolan Side Effects Report #5436014-2
FLOLAN problem was reported by a Physician from JAPAN on Aug 24, 2007. Female patient, 30 years of age, was diagnosed with eisenmenger's syndrome and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: asthma, cough, pneumonia. FLOLAN dosage: unknown. During the same period patient was treated with WARFARIN POTASSIUM, FUROSEMIDE, SPIRONOLACTONE, TRACLEER. Patient was hospitalized. Patient recovered.
Flolan Side Effects Report #5443393-9
Physician from JAPAN reported FLOLAN problem on Aug 27, 2007. Female patient, 34 years of age, was diagnosed with pulmonary hypertension and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: basedow's disease, dyspnoea exertional, hyperthyroidism, right ventricular failure. FLOLAN dosage: unknown. During the same period patient was treated with MERCAZOLE. Patient was hospitalized. Patient recovered.
Flolan Side Effects Report #5450950-2
FLOLAN problem was reported by a Health Professional from UNITED STATES on Sept 11, 2007. Female patient, 75 years of age, was diagnosed with pulmonary hypertension and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: catheter related complication, hypotension, loss of consciousness, oxygen saturation decreased, pulmonary hypertension. FLOLAN dosage: unknown. Patient died on 05/09/2007.
Flolan Side Effects Report #5464255-7
Physician from UNITED STATES reported FLOLAN problem on Sept 17, 2007. Female patient, 26 years of age, weighting 195.0 lb, was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: arthralgia, diarrhoea, dyskinesia, dyspnoea, erythema, feeling hot, headache, hepatic failure, nausea. FLOLAN dosage: unknown. During the same period patient was treated with FUROSEMIDE, POTASSIUM CHLORIDE, IMODIUM, COUMADIN, CLINDAMYCIN, AMITRIPTYLINE, LASIX. Patient was hospitalized. Patient died.
Flolan Side Effects Report #5464264-8
FLOLAN problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 17, 2007. Female patient, 50 years of age, weighting 150.4 lb, was diagnosed with pulmonary hypertension and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: hyperthyroidism, pancreatitis. FLOLAN dosage: unknown. During the same period patient was treated with WARFARIN, FUROSEMIDE, POTASSIUM CHLORIDE, SPIRONOLACTONE. Patient recovered.
Flolan Side Effects Report #5468318-1
Pharmacist from CANADA reported FLOLAN problem on Sept 20, 2007. Female patient, 61 years of age, was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: fatigue, oedema, pulmonary hypertension. FLOLAN dosage: unknown. During the same period patient was treated with SILDENAFIL. Patient died on 07/08/2007.
Flolan Side Effects Report #5471018-5
FLOLAN problem was reported by a Health Professional from AUSTRALIA on Sept 20, 2007. Female patient, 34 years of age, weighting 143.3 lb, was diagnosed with pulmonary hypertension and was treated with FLOLAN. After drug was administered, patient experienced the following problems/side effects: thrombosis. FLOLAN dosage: unknown. During the same period patient was treated with WARFARIN, BOSENTAN. Patient recovered.
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