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Tracleer Side Effects summary

Total Tracleer reports: 563.
Tracleer FDA safety alerts: 2006 .
Reported deaths: 197    Reported hospitalizations: 278.
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Tracleer Side Effects: aspartate aminotransferase increased, alanine aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, condition aggravated, anaemia, pulmonary hypertension, hepatic function abnormal, oedema peripheral, cardiac failure congestive, liver function test abnormal,
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Tracleer Side Effects reported to FDA

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Tracleer Side Effects Report #5549934-5
Consumer or non-health professional from UNITED STATES reported TRACLEER problem on Nov 23, 2007. Female patient, 26 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: pregnancy. TRACLEER dosage: unknown. Patient recovered.



Tracleer Side Effects Report #5552001-8
TRACLEER problem was reported by a Consumer or non-health professional from JAPAN on Nov 22, 2007. Male patient, 76 years of age, weighting 116.8 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, cardiac arrest. TRACLEER dosage: 62.5 MG, QD, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with WARFARIN POTASSIUM, ISOSORBIDE MONONITRATE, OXYGEN. Patient died on 04/23/2007.



Tracleer Side Effects Report #5552003-1
Pharmacist from UNITED KINGDOM reported TRACLEER problem on Nov 22, 2007. Female patient, 77 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: mania. TRACLEER dosage: 125 MG, BID, ORAL. During the same period patient was treated with SPIRONOLACTONE. Patient recovered.



Tracleer Side Effects Report #5552171-1
TRACLEER problem was reported by a Health Professional from BELGIUM on Nov 26, 2007. Female patient, 37 years of age, weighting 186.1 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: endarterectomy, pulmonary embolism. TRACLEER dosage: 125 MG, BID, ORAL, 62.5 MG, BID, ORAL. During the same period patient was treated with HALDOL, LORAZEPAM, MARCUMAR, CLOPIXOL, ZOLPIDEM TARTRATE. Patient was hospitalized. Patient recovered.




Tracleer Side Effects Report #5552173-5
Pharmacist from FRANCE reported TRACLEER problem on Nov 29, 2007. Female patient, 26 years of age, was diagnosed with accidental exposure and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: accidental exposure. TRACLEER dosage: unknown. Patient recovered.



Tracleer Side Effects Report #5552177-2
TRACLEER problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Nov 26, 2007. Female patient, 37 years of age, was diagnosed with skin ulcer and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: blister, oedema peripheral, rash, skin ulcer. TRACLEER dosage: 125 MG, BID, ORAL. During the same period patient was treated with DICLOFENAC, FLUOXETINE, LANSOPRAZOLE, OXYCODONE. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5564720-8
Physician from JAPAN reported TRACLEER problem on Nov 30, 2007. Female patient, 65 years of age, weighting 85.98 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: asthenia, dyspnoea. TRACLEER dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with WARFARIN POTASSIUM, SPIRONOLACTONE, PLAUNOTOL, ERYTHROMYCIN ETHYLSUCCINATE, RISEDRONATE, ALFACALCIDOL, CALCIUM LACTATE, OXYGEN. Patient died on 01/01/2007.



Tracleer Side Effects Report #5564721-X
TRACLEER problem was reported by a Physician from AUSTRIA on Nov 28, 2007. Female patient, 67 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: activated partial thromboplastin time prolonged, cerebral haemorrhage, fall, international normalised ratio increased, prothrombin level decreased. TRACLEER dosage: 125 MG, BID, ORAL; 62.5 ,G. BOD. PRA;. During the same period patient was treated with SINTROM, NOVOMIX, DIGIMERCK, LASIX, CONCOR, RENITEC, OMEPRAZOLE. Patient was hospitalized. Patient died on 08/20/2004.



Tracleer Side Effects Report #5564724-5
Consumer or non-health professional from SPAIN reported TRACLEER problem on Nov 30, 2007. Female patient, 69 years of age, weighting 127.9 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, cholestasis, gamma-glutamyltransferase increased, liver function test abnormal. TRACLEER dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with CARBAMAZEPINE, ATORVASTATIN CALCIUM, SINTROM, COZAAR PLUS, NEXIUM, ACTONEL. Patient was hospitalized. Patient recovered.




Tracleer Side Effects Report #5564745-2
TRACLEER problem was reported by a Consumer or non-health professional from GERMANY on Dec 01, 2007. Male patient, 64 years of age, was diagnosed with pulmonary fibrosis and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: colitis ischaemic, colitis ulcerative, helicobacter gastritis. TRACLEER dosage: 80.5 MG, ORAL. During the same period patient was treated with PANTOZOL, DECORTIN, ACETYLSALICYLIC ACID SRT, DYTIDE, SPIRIVA, SYMBICORT. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5564776-2
Consumer or non-health professional from JAPAN reported TRACLEER problem on Nov 26, 2007. Female patient, 76 years of age, weighting 83.78 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: carcinoembryonic antigen increased, gastric cancer stage ii, malignant pleural effusion, pericardial effusion malignant. TRACLEER dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with OXYGEN, BERAPROST, PREDNISONE, LEVOTHYROXINE, NILVADIPINE, ALENDRONATE, LANSOPRAZOLE, MAGNESIUM OXIDE. Patient died on 09/16/2005.



Tracleer Side Effects Report #5569874-5
TRACLEER problem was reported by a Physician from UNITED STATES on Nov 30, 2007. Female patient, 65 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: acute hepatic failure, antinuclear antibody positive, biliary dilatation, gallbladder disorder, hypotension, renal failure acute, serum ferritin increased. TRACLEER dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with SILDENAFIL CITRATE, ATACAND, PROTONIX, REGLAN, ASPIRIN, VITAMIN. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5569899-X
Physician from UNITED STATES reported TRACLEER problem on Dec 03, 2007. Female patient, 65 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood albumin decreased, blood alkaline phosphatase increased, blood bilirubin increased, fatigue, jaundice, malaise, myalgia. TRACLEER dosage: unknown. During the same period patient was treated with LIPITOR, LYRICA, AMARYL, GLUCOPHAGE, QUINAPRIL, ISOSORBIDE, VERAPAMIL, SYNTHROID. Patient recovered.



Tracleer Side Effects Report #5569962-3
TRACLEER problem was reported by a Consumer or non-health professional from PHILIPPINES on Feb 01, 2007. Female patient was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: accidental overdose. TRACLEER dosage: unknown. During the same period patient was treated with WARFARIN. Patient died.




Tracleer Side Effects Report #5569964-7
Health Professional from GERMANY reported TRACLEER problem on Dec 05, 2007. Female patient, 46 years of age, weighting 110.2 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic. TRACLEER dosage: 125 MG, BID, ORAL : 62.5 MG, BID, ORAL. During the same period patient was treated with SILDENAFIL CITRATE, LEVOTHYROXINE, ALLOPURINOL, DIGOXIN, TORSEMIDE, NEXIUM. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5569965-9
TRACLEER problem was reported by a Pharmacist from UNITED KINGDOM on Dec 04, 2007. Female patient, 77 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: mania. TRACLEER dosage: 125 MG, BID, ORAL : 62.5 MG, BID, ORAL. During the same period patient was treated with CANDESARTAN, SPIRONOLACTONE, FUROSEMIDE, OMEPRAZOLE, PRAVASTATIN, DILTIAZEM. Patient recovered.



Tracleer Side Effects Report #5569966-0
Health Professional from GERMANY reported TRACLEER problem on Dec 04, 2007. Male patient, 82 years of age, was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: haematocrit decreased, haemoglobin decreased. TRACLEER dosage: 62.5 MG, BID, ORAL. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5569967-2
TRACLEER problem was reported by a Physician from THAILAND on Dec 04, 2007. Female patient was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: epistaxis, haemoptysis. TRACLEER dosage: 62.5 MG, BID, ORAL. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5569970-2
Health Professional from JAPAN reported TRACLEER problem on Dec 04, 2007. Female patient, 59 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: cytomegalovirus infection, pancytopenia. TRACLEER dosage: 62.5 MG, QD, ORAL : 62.5 MG, BID, ORAL : 62.5 MG, TID, ORAL : 62.5 MG, QD, ORAL. During the same period patient was treated with SULFAMETHOXAZOLE W, AMLODIPINE, PITAVASTATIN CALCIUM, ANTIBIOTICS, URSODIOL. Patient was hospitalized. Patient recovered.




Tracleer Side Effects Report #5569971-4
TRACLEER problem was reported by a Health Professional from NETHERLANDS on Dec 03, 2007. Female patient, 54 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: ascites. TRACLEER dosage: unknown. Patient died on 09/23/2007.



Tracleer Side Effects Report #5574089-0
Physician from FRANCE reported TRACLEER problem on Dec 14, 2007. Male patient, 65 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: pneumonia. TRACLEER dosage: 125 MG,BID,ORAL; 62.5 MG,BID,ORAL. During the same period patient was treated with SILDENAFIL CITRATE. Patient died on 08/01/2007.



Tracleer Side Effects Report #5574090-7
TRACLEER problem was reported by a Physician from FRANCE on Dec 14, 2007. Male patient, 68 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: off label use, pneumonia. TRACLEER dosage: 125 MG,BID,ORAL; 62.5 MG,BID,ORAL. During the same period patient was treated with DIURETICS. Patient died on 02/01/2007.



Tracleer Side Effects Report #5574091-9
Consumer or non-health professional from GERMANY reported TRACLEER problem on Dec 11, 2007. Male patient, 59 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, pulmonary hypertension, right ventricular failure. TRACLEER dosage: unknown. During the same period patient was treated with TORSEMIDE, SPIRIVA, ISO MACK, VIANI. Patient was hospitalized. Patient died on 10/27/2007.



Tracleer Side Effects Report #5574092-0
TRACLEER problem was reported by a Consumer or non-health professional from FRANCE on Dec 17, 2007. Female patient, 56 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: cholestasis, type 2 diabetes mellitus. TRACLEER dosage: unknown. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5574093-2
Physician from ISRAEL reported TRACLEER problem on Dec 06, 2007. Female patient, child 3 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: pleural effusion, pulmonary oedema. TRACLEER dosage: 31.25 MG, BID, ORAL. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5574094-4
TRACLEER problem was reported by a Health Professional from NETHERLANDS on Dec 17, 2007. Female patient, 63 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. TRACLEER dosage: unknown. Patient died.



Tracleer Side Effects Report #5574095-6
Consumer or non-health professional from GERMANY reported TRACLEER problem on Dec 07, 2007. Female patient, 72 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, myositis. TRACLEER dosage: 62.5 MG, BID, ORAL. Patient recovered.



Tracleer Side Effects Report #5574096-8
TRACLEER problem was reported by a Physician from NETHERLANDS on Dec 17, 2007. Female patient, 75 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. TRACLEER dosage: unknown. Patient died.



Tracleer Side Effects Report #5574097-X
Physician from FRANCE reported TRACLEER problem on Dec 12, 2007. Female patient, 44 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: cytolytic hepatitis. TRACLEER dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with FLOLAN, LEVOTHYROXINE, LASIX, COUMADIN, POTASSIUM CHLORIDE. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5574113-5
TRACLEER problem was reported by a Consumer or non-health professional from JAPAN on Dec 07, 2007. Female patient, 33 years of age, weighting 119.0 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: deafness neurosensory, dizziness. TRACLEER dosage: 125 MG, BID, ORAL. During the same period patient was treated with SILDENAFIL CITRATE, FUROSEMIDE, SPIRONOLACTONE. Patient was hospitalized and became disabled. Patient recovered.



Tracleer Side Effects Report #5574420-6
Physician from UNITED STATES reported TRACLEER problem on Dec 04, 2007. Female patient, 44 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: abdominal pain, diarrhoea, hepatic fibrosis. TRACLEER dosage: unknown. Patient died on 01/01/2007.



Tracleer Side Effects Report #5574422-X
TRACLEER problem was reported by a Physician from UNITED STATES on Dec 11, 2007. Female patient, 64 years of age, weighting 171.1 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, blood potassium decreased, cough, dehydration, diarrhoea, dyspnoea exertional, faecaloma, ileus, insomnia. TRACLEER dosage: 125 MG, BID; 62.5 MG, BID, ORAL. During the same period patient was treated with PREDNISONE, NOVOLOG, LANTUS, SYNTHROID, CLONIDINE, CLONAZEPAM, NEXIUM, LASIX. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5574426-7
Physician from UNITED STATES reported TRACLEER problem on Dec 13, 2007. Male patient, 61 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: arthralgia, blood test abnormal, pharyngolaryngeal pain, polyarthritis. TRACLEER dosage: 125 MG, BID, ORAL, 62.5 MG, BID, ORAL. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5578453-5
TRACLEER problem was reported by a Physician from UNITED STATES on Dec 07, 2007. Male patient, 34 years of age, weighting 183.9 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: nasal congestion, palpitations, pneumonia, pulmonary oedema. TRACLEER dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with AMIODARONE, LASIX. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5578454-7
Physician from UNITED STATES reported TRACLEER problem on Dec 10, 2007. Male patient, 79 years of age, weighting 170.0 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: diarrhoea, pancreatitis. TRACLEER dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with SILDENAFIL CITRATE. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5578455-9
TRACLEER problem was reported by a Physician from UNITED STATES on Dec 18, 2007. Female patient, 49 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, body temperature increased, cardiac output decreased, dyspnoea, eye swelling, headache, international normalised ratio increased, lactic acidosis, lethargy. TRACLEER dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with REVATIO. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5578458-4
Physician from UNITED STATES reported TRACLEER problem on Dec 18, 2007. Female patient, 59 years of age, weighting 211.0 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: fall, hypotension, syncope. TRACLEER dosage: 62.5 MG, ORAL. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5578537-1
TRACLEER problem was reported by a Physician from NETHERLANDS on Dec 18, 2007. Male patient, 68 years of age, weighting 160.9 lb, was diagnosed with skin ulcer and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: oedema, toxic skin eruption. TRACLEER dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with EPOETIN BETA, CITALOPRAM HYDROBROMIDE, ENALAPRIL, LORAZEPAM, GLICLAZIDE, ACENOCOUMAROL, ACETYLSALICYLIC ACID SRT. Patient was hospitalized. Patient recovered.



Tracleer Side Effects Report #5578538-3
Consumer or non-health professional from AUSTRALIA reported TRACLEER problem on Dec 19, 2007. Female patient, 85 years of age, weighting 116.8 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: arthritis bacterial, musculoskeletal pain, prothrombin time prolonged, renal failure acute. TRACLEER dosage: 62.5 MG, BID, ORAL; 125 MG, BID, ORAL. Patient died on 09/24/2007.



Tracleer Side Effects Report #5578539-5
TRACLEER problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Dec 18, 2007. Female patient, 68 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: dysphagia, feeling abnormal, infection. TRACLEER dosage: unknown. Patient died.



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