Impaired Work Ability, Disturbance In Attention (8445247-2)
on Jun 12, 2012 Male patient from UNITED STATES , 48 years of age, weighting 180.0 lb, was diagnosed with

• blood cholesterol

and was treated with Pravastatin(View Usage). Patient experienced the following unwanted or unexpected effects: impaired work ability, disturbance in attention. Pravastatin dosage: 40 Mg Daily Po.

Dyspnoea, Platelet Count Decreased (8443792-7)
Patient was taking Pravastatin (View Usage). Patient had the following side effects: dyspnoea, platelet count decreased on Oct 19, 2011 from UNITED STATES Additional patient health information: Male patient , 43 years of age, weighting 402.3 lb, . Pravastatin dosage: N/A.
Patient was taking other medications:

• HYDRALAZINE HCL (View Hydralazine Hcl Review and Hydralazine Hcl Label )
• LANTUS (View Lantus Review and Lantus Label )
• ARANESP (View Aranesp Review and Aranesp Label )
• DEXAMETHASONE (View Dexamethasone Review and Dexamethasone Label )
• CALCIUM CARBONATE (View Calcium Carbonate Review and Calcium Carbonate Label )
• IRON (IRON) (View Iron (iron) Review and Iron (iron) Label )
• LASIX (View Lasix Review and Lasix Label )
• EPIVIR (View Epivir Review and Epivir Label )

Dry Mouth, Oral Pain, Abdominal Pain Lower, Mastication Disorder, Cystitis, Lip Swelling, Eczema, Back Pain, Gingival Pain (8437672-0)
Adverse event was reported on May 08, 2012 by a Female patient taking Pravastatin (View Usage) (Dosage: N/A) . Location: UNITED STATES , 68 years of age, After Pravastatin was administered, patient had the following side effects: dry mouth, oral pain, abdominal pain lower, mastication disorder, cystitis, lip swelling, eczema (eczema Questions), back pain (back pain Questions), gingival pain.
Patient was taking other medications:

• PROLIA (Unk Unk, Q6mo) (View Prolia Review and Prolia Label )
• PLAVIX (View Plavix Review and Plavix Label )

Alanine Aminotransferase Increased, Liver Function Test Abnormal, Aspartate Aminotransferase Increased (8431718-1)
on Jun 07, 2012 Male patient from UNITED STATES , 50 years of age, weighting 192.9 lb, was diagnosed with

• hyperlipidaemia

and was treated with Pravastatin (View Usage). Patient experienced the following unwanted or unexpected effects: alanine aminotransferase increased, liver function test abnormal, aspartate aminotransferase increased. Pravastatin dosage: 40 Mg Every Day Po.


Diverticulum Intestinal, Diverticular Perforation (8424587-7)
on May 30, 2012 Male patient from JAPAN , 76 years of age, weighting 172.0 lb, was treated with Pravastatin Sodium(View Usage). Patient had the following side effects: diverticulum intestinal, diverticular perforation. Pravastatin Sodium dosage: N/A.
Patient was taking other medications:

• OLMESARTAN MEDOXOMIL (20 Mg, Qd) (View Olmesartan Medoxomil Review and Olmesartan Medoxomil Label )
• VICTOZA (0.9 Mg, Qd) (View Victoza Review and Victoza Label )

Patient was hospitalized.

Electrocardiogram Qt Prolonged (8424019-9)
Patient was taking Pravastatin Sodium (View Usage). After Pravastatin was administered, patient had the following side effects: electrocardiogram qt prolonged on Jun 01, 2012 from UNITED STATES Additional patient health information: Male patient , 53 years of age, weighting 238.1 lb, . Pravastatin Sodium dosage: 20 Mg, Qd.
Patient was taking other medications:

• WARFARIN SODIUM (5 Mg On Tue/thurs/sat/sun And 10mg On Mon/wed/fri) (View Warfarin Sodium Review and Warfarin Sodium Label )
• CLINDAMYCIN (300 Mg, Tid) (View Clindamycin Review and Clindamycin Label )
• DOXYCYCLINE HYCLATE (50 Mg, Qd) (View Doxycycline Hyclate Review and Doxycycline Hyclate Label )
• FLUTICASONE PROPIONATE/SALMETEROL (Fluticasone 500mcg And Salmeterol 50mcg, Bid) (View Fluticasone Propionate/salmeterol Review and Fluticasone Propionate/salmeterol Label )
• ALLOPURINOL (100 Mg, Bid) (View Allopurinol Review and Allopurinol Label )
• LOSARTAN (50 Mg, Qd) (View Losartan Review and Losartan Label )
• MULTIVITAMIN (Unk Df, Qd) (View Multivitamin Review and Multivitamin Label )
• TIKOSYN (500 Mg, Bid) (View Tikosyn Review and Tikosyn Label )

Circulatory Collapse, Hepatitis Fulminant (8423475-X)
Adverse event was reported on Jun 04, 2012 by a Female patient taking Pravastatin Sodium (View Usage) (Dosage: Unk) . Location: JAPAN , weighting 125.7 lb, Patient experienced the following unwanted or unexpected effects: circulatory collapse, hepatitis fulminant.
Patient was taking other medications:

• FERROUS CITRATE (100 Mg, Unk) (View Ferrous Citrate Review and Ferrous Citrate Label )
• PROCHLORPERAZINE (15 Mg, Unk) (View Prochlorperazine Review and Prochlorperazine Label )
• GEMZAR (1500 Mg, Unk) (View Gemzar Review and Gemzar Label )
• GRANISETRON HYDROCHLORIDE (1 Mg, Unk) (View Granisetron Hydrochloride Review and Granisetron Hydrochloride Label )
• BETAMETHASONE (2 Mg, Unk) (View Betamethasone Review and Betamethasone Label )
• OXYCONTIN (15 Mg, Unk) (View Oxycontin Review and Oxycontin Label )
• BUP 4 (20 Mg, Unk) (View Bup-4 Review and Bup-4 Label )
• SUNRYTHM (75 Mg, Unk) (View Sunrythm Review and Sunrythm Label )

Abnormal Dreams (8423173-2)
on Jun 06, 2012 Female patient from UNITED STATES , weighting 145.0 lb, was diagnosed with

• blood cholesterol increased
• hypertension

and was treated with Pravastatin Sodium (View Usage). Patient had the following side effects: abnormal dreams. Pravastatin Sodium dosage: 40 Mg, Daily.
Patient was taking other medications:

• TIAZAC (360 Mg, Daily) (View Tiazac Review and Tiazac Label )
• CHANTIX (0.5 Mg, Daily) (View Chantix Review and Chantix Label )

Completed Suicide (8421210-2)
on Jun 07, 2012 Female patient from UNITED STATES , 60 years of age, was treated with Pravastatin(View Usage). After Pravastatin was administered, patient had the following side effects: completed suicide. Pravastatin dosage: N/A.
Patient was taking other medications:

• CALAN (View Calan Review and Calan Label )
• MIRTAZAPINE (View Mirtazapine Review and Mirtazapine Label )

Completed Suicide, Toxicity To Various Agents (8421169-8)
Patient was taking Pravastatin Sodium (View Usage). Patient experienced the following unwanted or unexpected effects: completed suicide, toxicity to various agents on Jun 07, 2012 from UNITED STATES Additional patient health information: Female patient , 60 years of age, . Pravastatin Sodium dosage: Unk.
Patient was taking other medications:

• MIRTAZAPINE (Unk) (View Mirtazapine Review and Mirtazapine Label )
• CALAN (Unk) (View Calan Review and Calan Label )

Product Substitution Issue, Diarrhoea, Product Quality Issue (8421155-8)
Adverse event was reported on Jun 04, 2012 by a Female patient taking Pravastatin (View Usage) (Dosage: 1 Tablet Qd Po) was diagnosed with

• blood cholesterol increased

and. Location: UNITED STATES , 69 years of age, weighting 110.0 lb, Patient had the following side effects: product substitution issue, diarrhoea, product quality issue.

Rash (8421078-4)
on Dec 08, 2011 Female patient from UNITED STATES , 62 years of age, weighting 165.0 lb, was treated with Pravastatin (View Usage). After Pravastatin was administered, patient had the following side effects: rash (rash Questions). Pravastatin dosage: N/A.
Patient was taking other medications:

• ASPIRIN (View Aspirin Review and Aspirin Label )
• ZOMETA (View Zometa Review and Zometa Label )
• HYDROCHLOROTHIAZIDE (View Hydrochlorothiazide Review and Hydrochlorothiazide Label )
• REVLIMID (10 Mg, 14/7, Po ; 10 Mg, 21/7, Po) (View Revlimid Review and Revlimid Label )

Muscle Rupture, Myalgia, Myocardial Infarction, Blood Cholesterol Abnormal (8419631-7)
on May 29, 2012 Male patient from GERMANY , weighting 187.4 lb, was diagnosed with

• blood cholesterol increased

and was treated with Pravastatin Sodium(View Usage). Patient experienced the following unwanted or unexpected effects: muscle rupture, myalgia, myocardial infarction, blood cholesterol abnormal. Pravastatin Sodium dosage: Pravastatin N Pravasin 30 Mg Tablets From 2004-05 For Increased Cholesterol.

Gynaecomastia, Breast Cancer (8419460-4)
Patient was taking Pravastatin Sodium (View Usage). Patient had the following side effects: gynaecomastia, breast cancer (breast cancer Questions) on Jun 01, 2012 from JAPAN Additional patient health information: Male patient , 78 years of age, . Pravastatin Sodium dosage: N/A.
Patient was taking other medications:

• URIEF (View Urief Review and Urief Label )
• DUTASTERIDE (.5mg Per Day) (View Dutasteride Review and Dutasteride Label )
• ADALAT (View Adalat Review and Adalat Label )
• LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (View Losartan Potassium And Hydrochlorothiazide Review and Losartan Potassium And Hydrochlorothiazide Label )

Acute Prerenal Failure, Dehydration, Urinary Tract Infection, Urethral Cancer Metastatic, Prostate Cancer, Bladder Transitional Cell Carcinoma (8418837-0)
Adverse event was reported on May 17, 2012 by a Male patient taking Pravastatin Sodium (View Usage) (Dosage: N/A) . Location: UNITED STATES , 78 years of age, After Pravastatin was administered, patient had the following side effects: acute prerenal failure, dehydration, urinary tract infection (urinary tract infection Questions), urethral cancer metastatic, prostate cancer (prostate cancer Questions), bladder transitional cell carcinoma.
Patient was taking other medications:

• PRAVACHOL (View Pravachol Review and Pravachol Label )
• MELOXICAM (View Meloxicam Review and Meloxicam Label )
• LISINOPRIL (View Lisinopril Review and Lisinopril Label )
• PANTOPRAZOLE SODIUM (View Pantoprazole Sodium Review and Pantoprazole Sodium Label )
• PROTONIX (View Protonix Review and Protonix Label )
• FLUTICASONE PROPIONATE (View Fluticasone Propionate Review and Fluticasone Propionate Label )
• IBUPROFEN (View Ibuprofen Review and Ibuprofen Label )
• ACTOS (30 Mg, 1 In 1 D,) (View Actos Review and Actos Label )

Patient was hospitalized.

Intestinal Mucosal Hypertrophy, Anaphylactic Shock, Renal Infarct (8416169-8)
on Jun 04, 2012 Male patient from GERMANY , weighting 163.1 lb, was treated with Pravastatin Sodium (View Usage). Patient experienced the following unwanted or unexpected effects: intestinal mucosal hypertrophy, anaphylactic shock, renal infarct. Pravastatin Sodium dosage: N/A.
Patient was taking other medications:

• IOPAMIDOL 370 (At A Rate Of 4.2 Ml/sec) (View Iopamidol-370 Review and Iopamidol-370 Label )
• IOPAMIDOL 370 (At A Rate Of 4.2 Ml/sec) (View Iopamidol-370 Review and Iopamidol-370 Label )
• ACETAMINOPHEN (View Acetaminophen Review and Acetaminophen Label )
• AMLODIPINE (View Amlodipine Review and Amlodipine Label )
• RABEPRAZOLE SODIUM (View Rabeprazole Sodium Review and Rabeprazole Sodium Label )

Anaphylactic Shock, Loss Of Consciousness, Pyrexia (8407224-7)
on May 01, 2000 Male patient from JAPAN , 62 years of age, weighting 154.3 lb, was treated with Pravastatin(View Usage). Patient had the following side effects: anaphylactic shock, loss of consciousness, pyrexia. Pravastatin dosage: N/A.
Patient was taking other medications:

• LORELCO (View Lorelco Review and Lorelco Label )
• DILTIAZEM HYDROCHLORIDE (View Diltiazem Hydrochloride Review and Diltiazem Hydrochloride Label )
• CLARITHROMYCIN (View Clarithromycin Review and Clarithromycin Label )
• SPARA (SAPRFLOXACIN) (View Spara (saprfloxacin) Review and Spara (saprfloxacin) Label )
• ISOSORBIDE MONONITRATE (View Isosorbide Mononitrate Review and Isosorbide Mononitrate Label )
• DIHIDROCODEINE PHOSPHATE (View Dihidrocodeine Phosphate Review and Dihidrocodeine Phosphate Label )
• PLETAL (100 Mg, Bid) (View Pletal Review and Pletal Label )

Hyperkalaemia, Fall, Renal Failure Acute, Obesity, Rhabdomyolysis, Hepatic Function Abnormal, Contusion, Myositis (8402312-3)
Patient was taking Pravastatin Sodium (View Usage). After Pravastatin was administered, patient had the following side effects: hyperkalaemia, fall (fall Questions), renal failure acute, obesity (obesity Questions), rhabdomyolysis, hepatic function abnormal, contusion, myositis (myositis Questions) on May 21, 2012 from JAPAN Additional patient health information: Male patient , 43 years of age, was diagnosed with

• hyperlipidaemia
• schizophrenia

and. Pravastatin Sodium dosage: N/A.
Patient was taking other medications:

• ABILIFY (View Abilify Review and Abilify Label )

Patient was hospitalized.

Interstitial Lung Disease (8402277-4)
Adverse event was reported on May 22, 2012 by a Female patient taking Pravastatin (View Usage) (Dosage: N/A) was diagnosed with

• hypercholesterolaemia

and. Location: FRANCE , 69 years of age, Patient experienced the following unwanted or unexpected effects: interstitial lung disease. Patient was hospitalized.

Laceration (8400224-2)
on May 24, 2012 Female patient from UNITED STATES , weighting 210.2 lb, was diagnosed with

• blood cholesterol increased
• ankylosing spondylitis (ankylosing spondylitis Questions)
• hypertension
• pain (pain Questions)
• neuropathy peripheral
• depression (depression Questions)

and was treated with Pravastatin (View Usage). Patient had the following side effects: laceration. Pravastatin dosage: N/A.
Patient was taking other medications:

• HUMIRA (View Humira Review and Humira Label )
• HYDROCHLOROTHIAZIDE (View Hydrochlorothiazide Review and Hydrochlorothiazide Label )
• VICOPROFEN (View Vicoprofen Review and Vicoprofen Label )
• NEURONTIN (View Neurontin Review and Neurontin Label )
• PROZAC (View Prozac Review and Prozac Label )

Hospitalisation (8398472-3)
on May 21, 2012 Female patient from UNITED STATES , 62 years of age, weighting 313.1 lb, was treated with Pravastatin(View Usage). After Pravastatin was administered, patient had the following side effects: hospitalisation. Pravastatin dosage: N/A.
Patient was taking other medications:

• PROBIOTICA (View Probiotica Review and Probiotica Label )
• ASPIRIN (View Aspirin Review and Aspirin Label )
• PLAVIX (View Plavix Review and Plavix Label )
• GLUCOSAMINE W (View Glucosamine W Review and Glucosamine W Label )
• BYETTA (View Byetta Review and Byetta Label )
• HEPARIN (View Heparin Review and Heparin Label )
• GEMFIBROZIL (View Gemfibrozil Review and Gemfibrozil Label )
• STOOL SOFTENER (View Stool Softener Review and Stool Softener Label )

Patient was hospitalized.

Malaise, Dyspnoea Exertional, Decreased Appetite, Dizziness, Toxicity To Various Agents, Blood Potassium Increased, Renal Impairment, Cough, White Blood Cell Count Increased (8398345-6)
Patient was taking Pravastatin (View Usage). Patient experienced the following unwanted or unexpected effects: malaise, dyspnoea exertional, decreased appetite, dizziness (dizziness Questions), toxicity to various agents, blood potassium increased, renal impairment, cough, white blood cell count increased on May 18, 2012 from CANADA Additional patient health information: Male patient , 83 years of age, . Pravastatin dosage: N/A.
Patient was taking other medications:

• ISOSORBIDE MONONITRATE (View Isosorbide Mononitrate Review and Isosorbide Mononitrate Label )
• BISOPROLOL FUMARATE (View Bisoprolol Fumarate Review and Bisoprolol Fumarate Label )
• POTASSIUM CHLORIDE (View Potassium Chloride Review and Potassium Chloride Label )
• FUROSEMIDE (View Furosemide Review and Furosemide Label )
• DIGOXIN (0.125 Mg Qs Oral) (View Digoxin Review and Digoxin Label )
• CLARITHROMYCIN (500 Mg Bid Oral) (View Clarithromycin Review and Clarithromycin Label )
• SPIRONOLACTONE (View Spironolactone Review and Spironolactone Label )
• CAPTOPRIL (View Captopril Review and Captopril Label )

Patient was hospitalized.

Breast Tenderness, Memory Impairment (8392403-8)
Adverse event was reported on May 14, 2012 by a Female patient taking Pravastatin Sodium (View Usage) (Dosage: 20 Mg, Daily) was diagnosed with

• hyperlipidaemia

and. Location: CANADA , 73 years of age, Patient had the following side effects: breast tenderness, memory impairment.

Atrial Fibrillation (8390674-5)
on May 17, 2012 Male patient from NETHERLANDS , 52 years of age, was diagnosed with

• hypercholesterolaemia

and was treated with Pravastatin Sodium (View Usage). After Pravastatin was administered, patient had the following side effects: atrial fibrillation (atrial fibrillation Questions). Pravastatin Sodium dosage: N/A.
Patient was taking other medications:

• ACENOCOUMAROL (View Acenocoumarol Review and Acenocoumarol Label )

Fall, Wrist Fracture (8389868-4)
on May 11, 2012 Female patient from UNITED STATES , 67 years of age, weighting 151.9 lb, was treated with Pravastatin(View Usage). Patient experienced the following unwanted or unexpected effects: fall (fall Questions), wrist fracture. Pravastatin dosage: N/A.
Patient was taking other medications:

• TENORMIN (View Tenormin Review and Tenormin Label )
• AMITRIPTYLINE HCL (View Amitriptyline Hcl Review and Amitriptyline Hcl Label )
• AMPYRA (10 Mg, Q, 12 Hrs, Oral) (View Ampyra Review and Ampyra Label )
• PERCOCET (View Percocet Review and Percocet Label )
• VALIUM (View Valium Review and Valium Label )