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Pravastatin Safety Reports submitted to FDA

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Total Pravastatin reports: 110.
Pravastatin FDA safety alerts: No.
Reported deaths: 7    Reported hospitalizations: 44.
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Reported Pravastatin Side Effects: renal failure acute, myalgia, rhabdomyolysis, guillain-barre syndrome, colitis ulcerative, pain in extremity, rectal haemorrhage, international normalised ratio increased, oedema peripheral, dizziness, gastrointestinal haemorrhage.
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Showing 1-100 of 110 Next >

Pravastatin Side Effects Report #5434312-X
Consumer or non-health professional from FRANCE reported PRAVASTATIN problem on Aug 17, 2007. Male patient, 56 years of age, was diagnosed with hypercholesterolaemia and was treated with PRAVASTATIN. After drug was administered, patient experienced the following problems/side effects: chest pain, herpes zoster, pain in extremity. PRAVASTATIN dosage: 20 MG (20 MG, 1 IN 1 D). Patient was hospitalized. Patient recovered.

Pravastatin Side Effects Report #5444420-5
PRAVASTATIN problem was reported by a Health Professional from NETHERLANDS on Aug 15, 2007. Female patient, 58 years of age, was treated with PRAVASTATIN. After drug was administered, patient experienced the following problems/side effects: arthritis, disturbance in attention, myalgia. PRAVASTATIN dosage: 40 MG; TAB; QD. During the same period patient was treated with ISOSORBIDE MONONITRATE. Patient recovered.

Pravastatin Side Effects Report #5442968-0
Health Professional from FRANCE reported PRAVASTATIN problem on Aug 29, 2007. Female patient, 16 years of age, was diagnosed with lipids abnormal, heart transplant and was treated with PRAVASTATIN. After drug was administered, patient experienced the following problems/side effects: diabetes mellitus. PRAVASTATIN dosage: unknown. During the same period patient was treated with PROGRAF, CELLCEPT, TARDYFERON, NEORAL. Patient was hospitalized. Patient recovered.

Pravastatin Side Effects Report #5447332-6
PRAVASTATIN problem was reported by a Health Professional from UNITED KINGDOM on Sept 07, 2007. Male patient, 58 years of age, was diagnosed with mitral valve replacement, hypercholesterolaemia and was treated with PRAVASTATIN. After drug was administered, patient experienced the following problems/side effects: guillain-barre syndrome, international normalised ratio increased, rectal haemorrhage, renal failure. PRAVASTATIN dosage: unknown. During the same period patient was treated with WARFARIN, AMLODIPINE BESYLATE, SIMVASTATIN, BISOPROLOL, RAMIPRIL, SPIRONOLACTONE. Patient was hospitalized. Patient recovered.

Pravastatin Side Effects Report #5448574-6
Physician from FRANCE reported PRAVASTATIN problem on Sept 06, 2007. Male patient, 65 years of age, was diagnosed with hypercholesterolaemia and was treated with PRAVASTATIN. After drug was administered, patient experienced the following problems/side effects: tendon rupture. PRAVASTATIN dosage: unknown. Patient recovered.

Pravastatin Side Effects Report #5449592-4
PRAVASTATIN problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Aug 16, 2007. Male patient, 58 years of age, was diagnosed with hypercholesterolaemia, mitral valve replacement and was treated with PRAVASTATIN. After drug was administered, patient experienced the following problems/side effects: eosinophil count increased, guillain-barre syndrome, haemoglobin decreased, hypersensitivity, hyponatraemia, international normalised ratio increased, nephritis, rectal haemorrhage. PRAVASTATIN dosage: unknown. During the same period patient was treated with AMLODIPINE BESYLATE, SIMVASTATIN, WARFARIN, BISOPROLOL FUMARATE, RAMIPRIL, SPIRONOLACTONE. Patient was hospitalized. Patient recovered.

Pravastatin Side Effects Report #5464237-5
Health Professional from JAPAN reported PRAVASTATIN problem on Sept 14, 2007. Male patient, 77 years of age, was diagnosed with hyperlipidaemia and was treated with PRAVASTATIN. After drug was administered, patient experienced the following problems/side effects: interstitial lung disease, polymyositis. PRAVASTATIN dosage: unknown. Patient was hospitalized. Patient died on 12/01/2006.

Pravastatin Side Effects Report #5465630-7
PRAVASTATIN problem was reported by a Pharmacist from UNITED STATES on Sept 20, 2007. Female patient, 40 years of age, weighting 140.0 lb, was diagnosed with type 1 diabetes mellitus and was treated with PRAVASTATIN. After drug was administered, patient experienced the following problems/side effects: dyspepsia. PRAVASTATIN dosage: unknown. Patient recovered.

Pravastatin Side Effects Report #5467084-3
Consumer or non-health professional from UNITED STATES reported PRAVASTATIN problem on Sept 21, 2007. Female patient, weighting 145.0 lb, was diagnosed with blood cholesterol increased and was treated with PRAVASTATIN. After drug was administered, patient experienced the following problems/side effects: rash. PRAVASTATIN dosage: unknown. Patient recovered.

Pravastatin Side Effects Report #5470244-9
PRAVASTATIN problem was reported by a Health Professional from UNITED STATES on Sept 10, 2007. Male patient, 42 years of age, was diagnosed with blood cholesterol and was treated with PRAVASTATIN. After drug was administered, patient experienced the following problems/side effects: ear discomfort, hypoacusis, nerve injury, pharmaceutical product counterfeit. PRAVASTATIN dosage: (20 MG), ORAL. Patient recovered.

Showing 1-100 of 110 Next >


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chest pain, herpes zoster, pain in extremity arthritis, disturbance in attention, myalgia diabetes mellitus, was diagnosed with hypercholesterolaemia and was diagnosed with lipids abnormal, heart transplant and