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Total Revatio reports: 73.Revatio FDA safety alerts: 2007 .
Reported deaths: 8 Reported hospitalizations: 18.
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FDA Reported Revatio Side Effects: headache, visual acuity reduced, pulmonary hypertension, dyspnoea, dizziness, vision blurred, cerebrovascular disorder, oxygen saturation decreased, condition aggravated, hepatic function abnormal, fatigue.
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Revatio Side Effects Report #5197639-5
Physician from GERMANY reported REVATIO problem on Dec 27, 2006. Male patient, weighting 299.8 lb, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: anaemia macrocytic. REVATIO dosage: DAILY DOSE:60MG. During the same period patient was treated with INSULIN, CORTISONE ACETATE. Patient was hospitalized. Patient recovered.
Revatio Side Effects Report #5213641-9
REVATIO problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 09, 2007. Female patient, weighting 201.1 lb, was diagnosed with pulmonary hypertension, diabetes mellitus insulin-dependent and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: pulmonary hypertension. REVATIO dosage: unknown. During the same period patient was treated with FUROSEMIDE, WARFARIN, AVAPRO, POLYETHYLENE GLYCOL, ACETAMINOPHEN, VERAPAMIL, TRACLEER, NOVOLOG. Patient recovered.
Revatio Side Effects Report #5234061-7
Consumer or non-health professional from UNITED STATES reported REVATIO problem on Jan 29, 2007. Female patient, weighting 201.1 lb, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: asthenia, feeling hot, flushing, nausea, nervousness, pallor, palpitations, pulmonary hypertension. REVATIO dosage: unknown. During the same period patient was treated with CAFFEINE, FUROSEMIDE, WARFARIN, AVAPRO, POLYETHYLENE GLYCOL, ACETAMINOPHEN, VERAPAMIL, TRACLEER. Patient recovered.
Revatio Side Effects Report #5236249-8
REVATIO problem was reported by a Physician from UNITED STATES on Feb 06, 2007. Female patient, weighting 201.1 lb, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: asthenia, feeling hot, flushing, nausea, nervousness, pallor, palpitations, pulmonary hypertension. REVATIO dosage: unknown. During the same period patient was treated with CAFFEINE, FUROSEMIDE, WARFARIN, AVAPRO, POLYETHYLENE GLYCOL, ACETAMINOPHEN, VERAPAMIL, TRACLEER. Patient recovered.
Revatio Side Effects Report #5237557-7
Health Professional from UNITED STATES reported REVATIO problem on Feb 01, 2007. Female patient, weighting 147.9 lb, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: pruritus, rash. REVATIO dosage: unknown. During the same period patient was treated with WARFARIN, FLONASE, LASIX, ILOPROST, NORVASC, XANAX. Patient recovered.
Revatio Side Effects Report #5254631-X
REVATIO problem was reported by a Consumer or non-health professional from NETHERLANDS on Feb 19, 2007. Male patient, 76 years of age, weighting 176.4 lb, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: haematuria, polyp. REVATIO dosage: unknown. During the same period patient was treated with ACENOCOUMAROL, FLUIMICIL, BUMETANIDE, SPIRIVA. Patient recovered.
Revatio Side Effects Report #5264033-8
Physician from ISRAEL reported REVATIO problem on Mar 05, 2007. Female patient, 49 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: neurogenic bladder, urinary tract infection. REVATIO dosage: DAILY DOSE:225MG. Patient recovered.
Revatio Side Effects Report #5269657-X
REVATIO problem was reported by a Physician from PORTUGAL on Mar 06, 2007. Male patient was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: hypotension. REVATIO dosage: DAILY DOSE:5MG. Patient recovered.
Revatio Side Effects Report #5270354-5
Health Professional from AUSTRALIA reported REVATIO problem on Mar 09, 2007. Female patient, weighting 101.4 lb, was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: gastric haemorrhage, haemoglobin decreased, haemolysis, renal disorder, scleroderma, thrombocytopenia. REVATIO dosage: unknown. During the same period patient was treated with RULIDE, BACTRIM DS, BOSENTAN, PANAFCORTELONE, NEXIUM, CAPTOPRIL, NORVASC, VALTREX. Patient was hospitalized. Patient recovered.
Revatio Side Effects Report #5270356-9
REVATIO problem was reported by a Physician from GERMANY on Mar 09, 2007. Female patient, weighting 152.1 lb, was diagnosed with pulmonary hypertension, cardiomyopathy and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: angioedema. REVATIO dosage: unknown. During the same period patient was treated with RAMIPRIL, ENAHEXAL, LEVOTHYROXINE, FINLEPSIN. Patient recovered.
Revatio Side Effects Report #5282198-9
Physician from ISRAEL reported REVATIO problem on Mar 22, 2007. Female patient, 49 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: neurogenic bladder, urinary tract infection. REVATIO dosage: DAILY DOSE:225MG. Patient recovered.
Revatio Side Effects Report #5295274-1
REVATIO problem was reported by a Physician from GERMANY on Apr 05, 2007. Male patient, 70 years of age, was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: visual acuity reduced. REVATIO dosage: unknown. Patient recovered.
Revatio Side Effects Report #5306533-8
Consumer or non-health professional from UNITED STATES reported REVATIO problem on Apr 12, 2007. Female patient, weighting 123.0 lb, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: asthenia, cardiac failure, dyspnoea, extrasystoles, hyperventilation, palpitations, respiratory disorder, unevaluable event. REVATIO dosage: unknown. During the same period patient was treated with DIURETICS, ANALGESICS, ACETYLSALICYLIC ACID SRT. Patient recovered.
Revatio Side Effects Report #5310501-X
REVATIO problem was reported by a Physician from UNITED STATES on Apr 13, 2007. Female patient, 40 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: ocular vascular disorder, vasoconstriction. REVATIO dosage: unknown. Patient recovered.
Revatio Side Effects Report #5326571-9
Health Professional from FRANCE reported REVATIO problem on May 04, 2007. Male patient, 17 years of age, was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: dermatitis, dry skin, painful erection. REVATIO dosage: unknown. Patient recovered.
Revatio Side Effects Report #5331650-6
REVATIO problem was reported by a Pharmacist from UNITED KINGDOM on May 15, 2007. Female patient, 71 years of age, was diagnosed with deep vein thrombosis, pulmonary embolism and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: international normalised ratio abnormal. REVATIO dosage: unknown. During the same period patient was treated with WARFARIN. Patient recovered.
Revatio Side Effects Report #5335577-5
Physician from GERMANY reported REVATIO problem on May 14, 2007. Male patient, 65 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: visual disturbance. REVATIO dosage: unknown. During the same period patient was treated with TRACLEER. Patient recovered.
Revatio Side Effects Report #5341970-7
REVATIO problem was reported by a Pharmacist from UNITED STATES on May 30, 2007. Female patient, 68 years of age, weighting 264.6 lb, was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest, ventricular fibrillation, ventricular tachycardia. REVATIO dosage: 50 MG EVERY 6 HOURS ORALLY. Patient was hospitalized. Patient recovered.
Revatio Side Effects Report #5342450-5
Physician from FRANCE reported REVATIO problem on May 24, 2007. Female patient, weighting 152.1 lb, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: ecchymosis, haemorrhage. REVATIO dosage: unknown. During the same period patient was treated with ILOPROST, MYCOPHENOLATE MOFETIL, TACROLIMUS, PREDNISONE, OMEPRAZOLE, FUROSEMIDE, INSULIN. Patient recovered.
Revatio Side Effects Report #5347544-6
REVATIO problem was reported by a Physician from AUSTRIA on May 24, 2007. Female patient, weighting 6.39 lb, was diagnosed with ill-defined disorder and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: retinal haemorrhage. REVATIO dosage: unknown. During the same period patient was treated with VITAMIN, OXYGEN. Patient recovered.
Revatio Side Effects Report #5349745-X
Consumer or non-health professional from UNITED STATES reported REVATIO problem on May 26, 2007. Male patient, 81 years of age, weighting 154.3 lb, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: abdominal distension, colon cancer, dyspnoea, gallbladder cancer, hepatic neoplasm malignant, metastases to abdominal cavity, weight decreased. REVATIO dosage: unknown. During the same period patient was treated with COREG, LASIX, PRILOSEC, FERROUS SULPHATE. Patient recovered.
Revatio Side Effects Report #5349771-0
REVATIO problem was reported by a Pharmacist from IRELAND on May 29, 2007. Male patient, 70 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: abdominal distension, myalgia. REVATIO dosage: unknown. Patient recovered.
Revatio Side Effects Report #5359381-7
Physician from GERMANY reported REVATIO problem on June 05, 2007. Male patient, 70 years of age, was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: disability, visual acuity reduced. REVATIO dosage: unknown. During the same period patient was treated with PLAVIX, ATACAND, ALLOPURINOL, SOSTRIL, SANDIMMUNE, TORSEMIDE, MAGNESIUM SULPHATE, TAVOR. Patient recovered.
Revatio Side Effects Report #5367963-1
REVATIO problem was reported by a Physician from AUSTRIA on June 12, 2007. Female patient, weighting 6.39 lb, was diagnosed with ill-defined disorder, pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: retinal haemorrhage. REVATIO dosage: unknown. During the same period patient was treated with VITAMIN, OXYGEN, VENDAL, TRUXAL. Patient recovered.
Revatio Side Effects Report #5370987-1
Physician from GERMANY reported REVATIO problem on June 15, 2007. Male patient, 65 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: visual disturbance. REVATIO dosage: unknown. During the same period patient was treated with TRACLEER. Patient recovered.
Revatio Side Effects Report #5373145-X
REVATIO problem was reported by a Pharmacist from CANADA on June 21, 2007. Male patient, 37 years of age, was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: hypoacusis. REVATIO dosage: unknown. During the same period patient was treated with FUROSEMIDE, ASAPHEN, NEORAL, PREDNISONE, AVELOX, BACTRIM, ATACAND. Patient recovered.
Revatio Side Effects Report #5043270-1
Physician from UNITED STATES reported REVATIO problem on July 03, 2006. Male patient, 53 years of age, weighting 232.0 lb, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: myalgia, rhabdomyolysis. REVATIO dosage: unknown. During the same period patient was treated with HYDROCHLOROTHIAZIDE, LISINOPRIL, NORVASC, FLOVENT, SEREVENT, ALBUTEROL INHALER PRN, SINGULAIR. Patient was hospitalized. Patient recovered.
Revatio Side Effects Report #5051460-7
REVATIO problem was reported by a Consumer or non-health professional from UNITED STATES on June 26, 2006. Female patient, 41 years of age, weighting 180.0 lb, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: amnesia, chest discomfort, confusional state, depressed level of consciousness, dizziness, dyspnoea, feeling abnormal, hangover, loss of consciousness. REVATIO dosage: 60 MG (20 MG, 3 IN 1 D);. During the same period patient was treated with MONTELUKAST, WELLBUTRIN, TERIPARATIDE, METHADONE, XANAX, BACLOFEN, POTASSIUM, MOMETASONE FUROATE. Patient recovered.
Revatio Side Effects Report #5061243-X
Physician from JAPAN reported REVATIO problem on July 08, 2006. Female patient, 41 years of age, weighting 121.3 lb, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: endarterectomy, fatigue, right ventricular failure. REVATIO dosage: 37.5 MG (12.5 MG, 3 IN 1 D), ORAL. During the same period patient was treated with WARFARIN, OXYGEN, PAXIL, GASMOTIN, MEILAX, BIOFERMIN R. Patient was hospitalized. Patient recovered.
Revatio Side Effects Report #5061245-3
REVATIO problem was reported by a Physician from JAPAN on July 08, 2006. Female patient, 41 years of age, weighting 114.6 lb, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: hepatic function abnormal, scleroderma. REVATIO dosage: 18.75 MG (6.25 MG, 3 IN 1 D), ORAL. During the same period patient was treated with TRACLEER, LASIX, ALDACTONE, FLOLAN. Patient recovered.
Revatio Side Effects Report #5062323-5
Physician from JAPAN reported REVATIO problem on July 08, 2006. Female patient, 70 years of age, weighting 120.4 lb, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: conjunctivitis, headache, hepatic function abnormal, interstitial lung disease. REVATIO dosage: 75 MG (25 MG, 3 IN 1 D), ORAL. During the same period patient was treated with TRACLEER, ZANTAC, METHYCOBAL, MUCOSTA, NEUER. Patient recovered.
Revatio Side Effects Report #5065728-1
REVATIO problem was reported by a Physician from JAPAN on July 12, 2006. Female patient, 41 years of age, weighting 114.6 lb, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: arthralgia, hepatic function abnormal, morphoea, raynaud's phenomenon, scleroderma. REVATIO dosage: 18.75 MG (6.25 MG, 3 IN 1 D), ORAL. During the same period patient was treated with TRACLEER, LASIX, ALDACTONE, FLOLAN. Patient recovered.
Revatio Side Effects Report #5065997-8
Pharmacist from CANADA reported REVATIO problem on July 13, 2006. Female patient was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: haematocrit decreased, haemoglobin decreased, leukopenia. REVATIO dosage: unknown. Patient recovered.
Revatio Side Effects Report #5087615-5
REVATIO problem was reported by a Pharmacist from UNITED STATES on Aug 08, 2006. Female patient, 74 years of age, weighting 131.8 lb, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: hallucination, visual. REVATIO dosage: 60 MG (20 MG, 3 IN 1 D) ORAL. During the same period patient was treated with OXYGEN, TRACLEER, ILOPROST, FOSAMAX, VITAMIN D, FUROSEMIDE, DIGOXIN. Patient recovered.
Revatio Side Effects Report #5090900-4
Health Professional from UNITED STATES reported REVATIO problem on Aug 10, 2006. Female patient, child 12 years of age, weighting 128.1 lb, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: eye swelling, swelling face. REVATIO dosage: 120 MG (40 MG, 3 IN 1 D). During the same period patient was treated with FLOLAN, PREVACID, PROPRANOLOL. Patient recovered.
Revatio Side Effects Report #5091604-4
REVATIO problem was reported by a Consumer or non-health professional from GERMANY on Aug 11, 2006. Female patient, 36 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: injury, keratorhexis, visual acuity reduced. REVATIO dosage: unknown. Patient recovered.
Revatio Side Effects Report #5092713-6
Pharmacist from UNITED STATES reported REVATIO problem on Aug 15, 2006. Male patient, 58 years of age, weighting 152.0 lb, was diagnosed with pulmonary hypertension, oesophagogastroduodenoscopy, bradycardia and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: agitation, bradycardia, cardiac arrest, dilatation atrial, dilatation ventricular, electromechanical dissociation, gaze palsy. REVATIO dosage: 60 MG (20 MG, 3 IN 1 D). During the same period patient was treated with DIPRIVAN, EPHEDRINE SUL CAP, SPORANOX, POTASSIUM, PREDNISONE, ADVAIR DISKUS, PHENYTOIN, NORTRIPTYLINE. Patient was hospitalized. Patient died on 01/01/2006.
Revatio Side Effects Report #5097047-1
REVATIO problem was reported by a Physician from GERMANY on Aug 22, 2006. Male patient, 62 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: balance disorder, headache, myalgia, vomiting. REVATIO dosage: 40 MG (20 MG, 2 IN 1 D), ORAL. During the same period patient was treated with INSULIN, ENALAPRIL MALEATE, TORSEMIDE, XIPAMIDE, DIPYRONE, VIAGRA. Patient was hospitalized. Patient recovered.
Revatio Side Effects Report #5105127-7
Pharmacist from UNITED STATES reported REVATIO problem on Aug 28, 2006. Female patient, 77 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: condition aggravated, rheumatoid arthritis. REVATIO dosage: unknown. During the same period patient was treated with ENBREL, PLAVIX, TRACLEER, LESCOL, METOPROLOL, FOLIC ACID, ACTONEL, ADVAIR DISKUS. Patient recovered.
Revatio Side Effects Report #5108010-6
REVATIO problem was reported by a Physician from FRANCE on Sept 01, 2006. Male patient, 54 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: condition aggravated, headache, hypotension, liver disorder, nasal congestion. REVATIO dosage: unknown. During the same period patient was treated with TRACLEER, BOSENTAN. Patient was hospitalized. Patient recovered.
Revatio Side Effects Report #5118575-6
Physician from BRAZIL reported REVATIO problem on Sept 14, 2006. Female patient was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: procedural complication, pulmonary hypertension. REVATIO dosage: unknown. During the same period patient was treated with ILOPROST. Patient recovered.
Revatio Side Effects Report #5121439-5
REVATIO problem was reported by a Pharmacist from UNITED STATES on Sept 19, 2006. Male patient, 58 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: oxygen saturation decreased. REVATIO dosage: 60 MG (20 MG, 3 IN 1 D). During the same period patient was treated with OXYGEN, ALBUTEROL, PREDNISONE, PLAVIX, FUROSEMIDE, CARDURA, SPIRIVA, ADVAIR DISKUS. Patient recovered.
Revatio Side Effects Report #5123195-3
Physician from GERMANY reported REVATIO problem on Sept 22, 2006. Female patient, 36 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: eye injury, keratorhexis. REVATIO dosage: unknown. During the same period patient was treated with TRACLEER. Patient recovered.
Revatio Side Effects Report #5129632-2
REVATIO problem was reported by a Pharmacist from UNITED STATES on Sept 29, 2006. Female patient, 79 years of age, weighting 78.00 lb, was diagnosed with pulmonary hypertension, cough and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: contusion, cough, skin discolouration. REVATIO dosage: 30 MG (10 MG, 3 IN 1 D), ORAL. During the same period patient was treated with AZITHROMYCIN, SPIRIVA, FUROSEMIDE, ENALAPRIL MALEATE, MIACALCIN, PILOCARPINE, DARVOCET. Patient recovered.
Revatio Side Effects Report #5142540-6
Health Professional from UNITED STATES reported REVATIO problem on Oct 17, 2006. Female patient was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: pancytopenia, platelet count decreased. REVATIO dosage: 75 MG (25 MG, 3 IN 1 D). Patient recovered.
Revatio Side Effects Report #5201802-4
REVATIO problem was reported by a Physician from UNITED STATES on Aug 11, 2006. Female patient, 61 years of age, weighting 148.0 lb, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, dizziness. REVATIO dosage: 60 MG (20 MG,3 IN 1 D). Patient recovered.
Revatio Side Effects Report #5152590-1
Physician from FRANCE reported REVATIO problem on Oct 30, 2006. Male patient, 72 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: haematuria. REVATIO dosage: unknown. During the same period patient was treated with PREVISCAN, TRACLEER. Patient recovered.
Revatio Side Effects Report #5154393-0
REVATIO problem was reported by a Consumer or non-health professional from GERMANY on Oct 30, 2006. Female patient, 70 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: cerebrovascular disorder, headache, visual acuity reduced, xanthopsia. REVATIO dosage: 80 MG (20 MG, 4 IN 1 D), ORAL. During the same period patient was treated with VIAGRA, MOLSIHEXAL, MARCUMAR, OXYGEN. Patient was hospitalized. Patient recovered.
Revatio Side Effects Report #5156455-0
Health Professional from UNITED STATES reported REVATIO problem on Oct 31, 2006. Female patient, child 12 years of age, weighting 128.1 lb, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: eye swelling, headache, lip swelling. REVATIO dosage: 120 MG (40 MG, 3 IN 1 D). During the same period patient was treated with FLOLAN, PREVACID, PROPRANOLOL. Patient recovered.
Revatio Side Effects Report #5156665-2
REVATIO problem was reported by a Pharmacist from UNITED STATES on Nov 02, 2006. Male patient, 79 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: hypertension. REVATIO dosage: unknown. During the same period patient was treated with NITROPRUSSIDE. Patient was hospitalized. Patient recovered.
Revatio Side Effects Report #5159933-3
Physician from UNITED STATES reported REVATIO problem on Nov 04, 2006. Female patient, 79 years of age, weighting 78.00 lb, was diagnosed with pulmonary hypertension, cough and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: breast pain, contusion, cough, cyanosis, dyspnoea, lethargy, rib fracture, stress. REVATIO dosage: 30 MG (10 MG, 3 IN 1 D), ORAL. During the same period patient was treated with AZITHROMYCIN, SPIRIVA, FUROSEMIDE, ENALAPRIL MALEATE, MIACALCIN, PILOCARPINE, DARVOCET. Patient recovered.
Revatio Side Effects Report #5164975-8
REVATIO problem was reported by a Physician from BRAZIL on Nov 06, 2006. Female patient was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: fatigue, oxygen saturation decreased. REVATIO dosage: 200 MG DAILY, ORAL. Patient recovered.
Revatio Side Effects Report #5164987-4
Consumer or non-health professional from GERMANY reported REVATIO problem on Nov 14, 2006. Female patient, 70 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: cerebral atrophy, cerebrovascular disorder, eye disorder, eye oedema, headache, vision blurred, visual acuity reduced. REVATIO dosage: 80 MG (20 MG, 4 IN 1 D), ORAL. During the same period patient was treated with VIAGRA, MOLSIHEXAL, MARCUMAR, OXYGEN. Patient was hospitalized. Patient recovered.
Revatio Side Effects Report #5165094-7
REVATIO problem was reported by a Physician from GERMANY on Nov 09, 2006. Male patient, 61 years of age, weighting 158.7 lb, was diagnosed with pulmonary hypertension, spinal disorder, depression, dyspepsia and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: amnesia, dizziness, liver function test abnormal, mobility decreased, renal failure. REVATIO dosage: 60 MG (20 MG, 3 IN 1 D), ORAL. During the same period patient was treated with OXYCODONE, DOXEPIN, OMEPRAZOLE, BENZODIAZEPINE DERIVATIVES, TORSEMIDE. Patient recovered.
Revatio Side Effects Report #5168502-0
Consumer or non-health professional from BRAZIL reported REVATIO problem on Nov 21, 2006. Male patient, 59 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: cardiogenic shock, condition aggravated, dyspnoea, swelling. REVATIO dosage: 60 MG (20 MG, 3 IN 1 D), ORAL. During the same period patient was treated with DIGOXIN, MARCUMAR, LASIX, PHENYTOIN, CLONAZEPAM. Patient was hospitalized. Patient died on 10/07/2006.
Revatio Side Effects Report #5168526-3
REVATIO problem was reported by a Physician from JAPAN on July 27, 2006. Female patient, 45 years of age, weighting 115.5 lb, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: oedema, off label use, right ventricular failure. REVATIO dosage: 75 MG (25 MG, 3 IN 1 D), ORAL. During the same period patient was treated with DORNER, LASIX, ALLOPURINOL, ZANTAC, ALDACTONE, WARFARIN, RANITIDINE. Patient died on 11/07/2004.
Revatio Side Effects Report #5174723-3
Physician from BRAZIL reported REVATIO problem on Nov 27, 2006. Female patient was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: fatigue, oxygen saturation decreased. REVATIO dosage: 300 MG (300 MG, 1 IN 1 D), ORAL. During the same period patient was treated with FUROSEMIDE. Patient recovered.
Revatio Side Effects Report #5187069-4
REVATIO problem was reported by a Physician from FRANCE on Dec 01, 2006. Male patient, 71 years of age, weighting 143.3 lb, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: calculus urinary, haematuria, international normalised ratio decreased, pulmonary hypertension. REVATIO dosage: unknown. During the same period patient was treated with PREVISCAN, TRACLEER. Patient recovered.
Revatio Side Effects Report #5191172-2
Physician from GERMANY reported REVATIO problem on Dec 07, 2006. Male patient, 65 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: blood bilirubin increased, gamma-glutamyltransferase increased. REVATIO dosage: 100 MG (50MG, 2 IN 1 D), ORAL. During the same period patient was treated with CLOPIDOGREL, SIMVASTATIN, ACETYLSALICYLIC ACID SRT, ACETYLCYSTEINE. Patient recovered.
Revatio Side Effects Report #5192224-3
REVATIO problem was reported by a Physician from GERMANY on Dec 13, 2006. Male patient was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: anaemia macrocytic. REVATIO dosage: unknown. During the same period patient was treated with CORTISONE ACETATE. Patient was hospitalized. Patient recovered.
Revatio Side Effects Report #5196346-2
Physician from GERMANY reported REVATIO problem on Dec 12, 2006. Female patient, 70 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: cerebral atrophy, cerebrovascular disorder, headache, macular oedema, maculopathy, optic neuropathy. REVATIO dosage: 60 MG (20 MG, 3 IN 1 D), ORAL. During the same period patient was treated with VIAGRA, MOLSIHEXAL, MARCUMAR, OXYGEN. Patient was hospitalized. Patient recovered.
Revatio Side Effects Report #5384721-2
REVATIO problem was reported by a Health Professional from UNITED STATES on June 29, 2007. Female patient, 82 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: arterial stenosis, photophobia, vision blurred, visual acuity reduced. REVATIO dosage: unknown. During the same period patient was treated with DIGITEK, MONTELUKAST, PRAVACHOL, DIAZEPAM, SYPRINE. Patient recovered.
Revatio Side Effects Report #5388483-4
Physician from GERMANY reported REVATIO problem on July 04, 2007. Male patient, 70 years of age, was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: disability, visual acuity reduced. REVATIO dosage: unknown. During the same period patient was treated with PLAVIX, ATACAND, ALLOPURINOL, SOSTRIL, SANDIMMUNE, TORSEMIDE, MAGNESIUM SULPHATE, TAVOR. Patient recovered.
Revatio Side Effects Report #5392810-1
REVATIO problem was reported by a Physician from SWEDEN on July 09, 2007. Male patient, 68 years of age, was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: abdominal distension, diarrhoea. REVATIO dosage: unknown. Patient was hospitalized. Patient recovered.
Revatio Side Effects Report #5392871-X
Consumer or non-health professional from GERMANY reported REVATIO problem on July 10, 2007. Female patient, 67 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: gamma-glutamyltransferase increased. REVATIO dosage: unknown. During the same period patient was treated with DIURETICS, ANTICOAGULANTS. Patient recovered.
Revatio Side Effects Report #5394653-1
REVATIO problem was reported by a Health Professional from UNITED STATES on July 11, 2007. Female patient, 82 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: arterial stenosis, photophobia, vision blurred, visual acuity reduced. REVATIO dosage: unknown. During the same period patient was treated with DIGITEK, MONTELUKAST, PRAVACHOL, DIAZEPAM, SYPRINE. Patient recovered.
Revatio Side Effects Report #5415973-8
Physician from BRAZIL reported REVATIO problem on Aug 06, 2007. Female patient was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: multi-organ failure. REVATIO dosage: DAILY DOSE:120MG. Patient died on 08/01/2007.
Revatio Side Effects Report #5425580-9
REVATIO problem was reported by a Physician from BRAZIL on Aug 14, 2007. Female patient, 54 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: hepatic failure, multi-organ failure, platelet count decreased, pulmonary hypertension, respiratory tract infection, schistosomiasis. REVATIO dosage: DAILY DOSE:120MG. During the same period patient was treated with FUROSEMIDE, SPIRONOLACTONE, DIGOXIN. Patient was hospitalized. Patient died on 08/01/2007.
Revatio Side Effects Report #5425600-1
Consumer or non-health professional from NETHERLANDS reported REVATIO problem on Aug 13, 2007. Female patient, 63 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: hip surgery. REVATIO dosage: unknown. During the same period patient was treated with ANTICOAGULANTS. Patient died.
Revatio Side Effects Report #5428043-X
REVATIO problem was reported by a Physician from GERMANY on Aug 21, 2007. Female patient, weighting 77.16 lb, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: cardiac failure, diarrhoea, pancreatic carcinoma metastatic. REVATIO dosage: DAILY DOSE:30MG. During the same period patient was treated with BOSENTAN. Patient was hospitalized. Patient recovered.
Revatio Side Effects Report #5443957-2
Physician from UNITED STATES reported REVATIO problem on Aug 24, 2007. Male patient, 35 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: bronchospasm, dizziness, dyspnoea, headache, throat tightness. REVATIO dosage: unknown. During the same period patient was treated with BOSENTAN. Patient recovered.
Revatio Side Effects Report #5446842-5
REVATIO problem was reported by a Physician from BRAZIL on Aug 28, 2007. Female patient was diagnosed with pulmonary hypertension and was treated with REVATIO. REVATIO dosage: DAILY DOSE:150MG. During the same period patient was treated with BOSENTAN. Patient died.
Revatio Side Effects Report #5464628-2
Physician from BRAZIL reported REVATIO problem on Sept 11, 2007. Female patient, 54 years of age, was diagnosed with pulmonary hypertension and was treated with REVATIO. After drug was administered, patient experienced the following problems/side effects: cardiac failure, pulmonary hypertension. REVATIO dosage: DAILY DOSE:150MG. During the same period patient was treated with BOSENTAN, ANTITHROMBOTIC AGENTS, CORTICOSTEROIDS, DIURETICS. Patient was hospitalized. Patient died on 08/01/2007.
Drug Information: Sildenafil
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a699015.html
(sil den' a fil)Why is this medication prescribed?
Sildenafil (Viagra) is used to treat erectile dysfunction (impotence; inability to get or keep an erection) in men. Sildenafil (Revatio) is used to improve the ability to exercise in people with pulmonary arterial hypertension (PAH; high blood pressure in the vessels carrying blood to the lungs, causing shortness of breath, dizziness, and tiredness). Sildenafil is in a class of medications called phosphodiesterase (PDE) inhibitors. Sildenafil treats erectile dysfunction by increasing blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection. Sildenafil treats PAH by relaxing the blood vessels in the lungs to allow blood to flow easily.
If you are taking sildenafil to treat erectile dysfunction, you should know that it does not cure erectile dysfunction or increase sexual desire. Sildenafil does not prevent pregnancy or the spread of sexually transmitted diseases such as human immunodeficiency virus (HIV).
How should this medicine be used?
Sildenafil comes as a tablet to take by mouth.
If you are taking sildenafil to treat erectile dysfunction, follow your doctor's directions and the guidelines in this paragraph. Take sildenafil as needed before sexual activity. The best time to take sildenafil is about 1 hour before sexual activity, but you can take the medication any time from 4 hours to 30 minutes before sexual activity. Sildenafil usually should not be taken more than once every 24 hours. If you have certain health conditions or are taking certain medications, your doctor may tell you to take sildenafil less often. You can take sildenafil with or without food. However, if you take sildenafil with a high-fat meal, it will take longer for the medication to start to work.
If you are taking sildenafil to treat PAH, follow your doctor's directions and the guidelines in this paragraph. You will probably take sildenafil three times a day with or without food. Take sildenafil at around the same times every day, and space your doses about 4 to 6 hours apart.
Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take sildenafil exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
If you are taking sildenafil for erectile dysfunction, your doctor will probably start you on an average dose of sildenafil and increase or decrease your dose depending on your response to the medication. Tell your doctor if sildenafil is not working well or if you are experiencing side effects.
If you are taking sildenafil for PAH, you should know that sildenafil controls PAH but does not cure it. Continue to take sildenafil even if you feel well. Do not stop taking sildenafil without talking to your doctor.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Other uses for this medicine
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking sildenafil,
- tell your doctor and pharmacist if you are allergic to sildenafil or any other medications.
- do not take sildenafil if you are taking or have recently taken nitrates (medications for chest pain) such as isosorbide dinitrate (Isordil), isosorbide mononitrate (Imdur, ISMO), and nitroglycerin (Nitro-BID, Nitro-Dur, Nitroquick, Nitrostat, others). Nitrates come as tablets, sublingual (under the tongue) tablets, sprays, patches, pastes, and ointments. Ask your doctor if you are not sure whether any of your medications contain nitrates.
- do not take street drugs containing nitrates such as amyl nitrate and butyl nitrate ('poppers') while taking sildenafil.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), tamsulosin (Flomax), and terazosin (Hytrin); amlodipine (Norvasc); certain antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral); anticoagulants ('blood thinners') such as warfarin (Coumadin); certain barbiturates such as butalbital (in Esgic-Plus, in Fioricet, in Fiorinal, others) and secobarbital (Seconal); beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); bosentan (Tracleer); cimetidine (Tagamet);efavirenz (Sustiva); erythromycin (E.E.S., E-Mycin, Erythrocin); HIV protease inhibitors including amprenavir (Agenerase), atazanavir (Reyataz), darunavir (Prezista), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), saquinavir (Fortovase, Invirase), and tipranavir (Aptivus); nevirapine (Viramune); other medications or devices to treat erectile dysfunction;medications for high blood pressure; certain medications for seizures including carbamazepine (Carbatrol, Epitol, Tegretol), phenobarbital, and phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin); and rifampin (Rifadin, Rimactane). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with sildenafil, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
- tell your doctor what herbal products you are taking or plan to take, especially St. John's wort.
- tell your doctor if you smoke, if you have ever had an erection that lasted for several hours, and if you have recently lost a large amount of body fluids (dehydration). This can happen if you are sick with fever, diarrhea, or vomiting; sweat a lot; or do not drink enough liquids. Also tell your doctor if you have or have ever had pulmonary veno-occlusive disease (PVOD; blockage of veins in the lungs); a stomach ulcer; heart, kidney, or liver disease; a heart attack; an irregular heartbeat; a stroke; chest pain; high or low blood pressure; high cholesterol; a bleeding disorder; blood circulation problems;blood cell problems such as sickle cell anemia (a disease of the red blood cells), multiple myeloma (cancer of the plasma cells), or leukemia (cancer of the white blood cells); conditions affecting the shape of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie's disease); or diabetes. Also tell your doctor if you or any of your family members have or have ever had an eye disease such as retinitis pigmentosa (an inherited eye condition that causes loss of vision) or if you have ever had sudden severe vision loss, especially if you were told that the vision loss was caused by a blockage of blood flow to the nerves that help you see.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking sildenafil, call your doctor.
- if you are having surgery, including dental surgery, tell your doctor or dentist that you are taking sildenafil.
- if you are taking sildenafil to treat erectile dysfunction, tell your doctor if you have ever been advised by a health care professional to avoid sexual activity for medical reasons or if you have ever experienced chest pain during sexual activity. Sexual activity may be a strain on your heart, especially if you have heart disease. If you experience chest pain, dizziness, or nausea during sexual activity, call your doctor immediately and avoid sexual activity until your doctor tells you otherwise.
- tell all your health care providers that you are taking sildenafil. If you ever need emergency medical treatment for a heart problem, the health care providers who treat you will need to know when you last took sildenafil.
What special dietary instructions should I follow?
Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.
What should I do if I forget a dose?
If you are taking sildenafil for erectile dysfunction, you are unlikely to miss a dose since this medication is taken as needed, not on a regular dosing schedule.
If you are taking sildenafil for PAH, 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?
Sildenafil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- headache
- heartburn
- diarrhea
- flushing (feeling of warmth)
- nosebleeds
- difficulty falling asleep or staying asleep
- numbness, burning, or tingling in the arms, hands, feet, or legs
- muscle aches
- changes in color vision (seeing a blue tinge on objects or having difficulty telling the difference between blue and green)
- sensitivity to light
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
- sudden severe loss of vision (see below for more information)
- blurred vision
- sudden decrease or loss of hearing
- ringing in ears
- erection that is painful or lasts longer than 4 hours
- dizziness or lightheadedness
- fainting
- chest pain
- worsening shortness of breath
- itching or burning during urination
- rash
Some patients experienced a sudden loss of some or all of their vision after they took sildenafil or other medications that are similar to sildenafil. The vision loss was permanent in some cases. It is not known if the vision loss was caused by the medication. If you experience a sudden loss of vision while you are taking sildenafil, call your doctor immediately. Do not take any more doses of sildenafil or similar medications such as tadalafil (Cialis) or vardenafil (Levitra) until you talk to your doctor.
There have been reports of heart attack, stroke, irregular heartbeat, bleeding in the brain or lungs, high blood pressure, and sudden death in men who took sildenafil for erectile dysfunction. Most, but not all, of these people had heart problems before taking sildenafil. It is not known whether these events were caused by sildenafil, sexual activity, heart disease, or a combination of these and other causes.Talk to your doctor about the risks of taking sildenafil.
Some patients experienced a sudden decrease or loss of hearing after they took sildenafil or other medications that are similar to sildenafil. The hearing loss usually involved only one ear and may not get better. It is not known if the hearing loss was caused by the medication. If you experience a sudden loss of hearing, sometimes with ringing in the ears or dizziness, while you are taking sildenafil, call your doctor immediately. If you are taking sildenafil (Viagra) for erectile dysfunction, do not take any more doses of sildenafil (Viagra) or similar medications such as tadalafil (Cialis) or vardenafil (Levitra) until you talk to your doctor. If you are taking sildenafil (Revatio) for PAH, do not stop taking your medication until you talk to your doctor.
Sildenafil may cause other side effects. Call your doctor if you have any unusual problems while you are 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). 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.
What other information should I know?
Keep all appointments with your doctor.
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.
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