This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Pravachol (Pravastatin) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (119)
Life Threatening Events (9)
Disability (7)
Reports by Reaction Type
Myalgia (21),
Pain in Extremity (15),
Arthralgia (14),
Drug Ineffective (13),
Drug Hypersensitivity (13),
LOW Density Lipoprotein Increased (11),
Musculoskeletal Pain (9),
High Density Lipoprotein Decreased (7),
Blood Cholesterol Increased (7),
Nausea (7),
Muscular Weakness (7),
Muscle Atrophy (6)
Below are a few examples of reports where side effects / adverse reactions may be related to Pravachol (Pravastatin). For a complete list or a specific selection of reports, please use the links above.
Possible Pravachol side effects in 55 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 55 year old female
Reactions: Vitamin D Deficiency, Muscle Atrophy, Pain in Extremity, Myocardial Infarction, LOW Density Lipoprotein Increased, Muscle Rupture, Muscle Spasms
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Crestor
Indication: Product Used FOR Unknown Indication
Lipitor
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Lovaza
Dosage: 4cap per day
Administration route: Oral
Indication: Blood Triglycerides Increased
Start date: 2008-05-01
Pravachol
Indication: Product Used FOR Unknown Indication
Trilipix
Indication: Blood Triglycerides Increased
Other drugs received by patient: Metformin HCL; Calcium; Lisinopril; Aspirin; Fenofibrate; Metoprolol; Plavix; Imdur
Possible Pravachol side effects in 66 year old
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 66 year old
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Fosamax
Dosage: unk
Levaquin
Dosage: unk
Lisinopril
Dosage: unk
Morphine Sulfate
Dosage: unk
Pravachol
Dosage: unk
Vancomycin HCL
Dosage: unk
Possible Pravachol side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03
Patient:
Reactions: Myalgia, Muscular Weakness, Musculoskeletal Stiffness
Drug(s) suspected as cause:
Crestor
Lipitor
Lyrica
Dosage: 75 mg, bid
Administration route: Oral
Paxil
Pravachol
Tricor
Zocor
Administration route: Oral
Other drugs received by patient: Minocycline HCL; Cymbalta; Cyanocobalamin; Calcium (Unspecified); Ascorbic Acid; Savella; Metformin HCL; Vitamins (Unspecified); Sotalol Hydrochloride; Glyburide; Lovaza; Januvia; Lantus; Zetia; Losartan Potassium; Ciprofloxacin; Aspirin
Possible Pravachol side effects in
Reported by a consumer/non-health professional from United States on 2012-08-03
Patient:
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Morphine Sulfate
Dosage: unk
Pravachol
Dosage: unk
Pseudoephedrine HCL
Dosage: unk
Possible Pravachol side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-03
Patient: female, weighing 65.8 kg (144.8 pounds)
Reactions: Myalgia
Drug(s) suspected as cause:
Niaspan
Dosage: at bedtime
Indication: Blood Cholesterol Increased
Start date: 2011-03-01
Pravachol
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Vitamin TAB; Aspirin; Fenofibrate; Coq10; Calcium Carbonate
Possible Pravachol side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01
Patient:
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Ambien CR
Amoxicillin
Dosage: 0.5, qd
Arthrotec
Administration route: Oral
Biaxin
Cefzil
Lipitor
Administration route: Oral
Livalo
Lortab
Oxacillin Sodium
PCE
Pravachol
Provigil
Sulfamethoxazole
Ultram
Zetia
Administration route: Oral
Zocor
Administration route: Oral
Possible Pravachol side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31
Patient:
Reactions: Burning Sensation, Hot Flush, Drug Ineffective
Drug(s) suspected as cause:
Mevacor
Administration route: Oral
Niacin
Pravachol
Zocor
Administration route: Oral
Other drugs received by patient: Xanax
Possible Pravachol side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-30
Patient: male
Reactions: Myalgia, Neoplasm Malignant, Rash
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Crestor
Indication: Product Used FOR Unknown Indication
Lipitor
Indication: Product Used FOR Unknown Indication
Mavik
Indication: Product Used FOR Unknown Indication
Pravachol
Indication: Product Used FOR Unknown Indication
Ticlid
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Tikosyn
Possible Pravachol side effects in 62 year old male
Reported by a consumer/non-health professional from United States on 2012-07-27
Patient: 62 year old male
Reactions: Throat Tightness
Drug(s) suspected as cause:
Pravachol
Other drugs received by patient: Nasonex; Metformin HCL; Furosemide; Losartan Potassium; Xanax; Protonix; Torsemide; Plavix; Flonase; Effexor XR; Tricor; Amlodipine; Amitriptyline Hydrochloride; Levothyroxine Sodium; Toprol-XL; Nitroglycerin; Acetylsalicylic Acid SRT; Imdur; Zofran
Possible Pravachol side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-23
Patient: female
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Cardizem
Lipitor
Dosage: unk
Administration route: Oral
Lisinopril
Pravachol
Possible Pravachol side effects in
Reported by a consumer/non-health professional from United States on 2012-07-20
Patient:
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Amiodarone HCL
Dosage: unk
Pravachol
Dosage: unk
Procanbid
Dosage: unk
Possible Pravachol side effects in 74 year old female
Reported by a consumer/non-health professional from United States on 2012-07-20
Patient: 74 year old female, weighing 49.0 kg (107.8 pounds)
Reactions: Abdominal Discomfort, Gastrointestinal Haemorrhage, Nausea, Asthenia, Melaena
Drug(s) suspected as cause:
Pravachol
Other drugs received by patient: Lisinopril; Nexium; Clonidine
Possible Pravachol side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-12
Patient: male
Reactions: Myalgia, Drug Hypersensitivity
Drug(s) suspected as cause:
Crestor
Dosage: unk
Lipitor
Dosage: unk
Pravachol
Dosage: unk
Possible Pravachol side effects in female
Reported by a physician from United States on 2012-06-26
Patient: female
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Ambien CR
Dosage: unk
Amoxicillin
Dosage: 0.5 unk, 1x/day
Arthrotec
Dosage: unk
Administration route: Oral
Biaxin
Dosage: unk
Cefzil
Dosage: unk
Lipitor
Dosage: unk
Administration route: Oral
Livalo
Dosage: unk
Lortab
Dosage: unk
Oxacillin Sodium
Dosage: unk
PCE
Dosage: unk
Pravachol
Dosage: unk
Provigil
Dosage: unk
Sulfamethoxazole
Dosage: unk
Ultram
Dosage: unk
Zetia
Dosage: unk
Zocor
Dosage: unk
Possible Pravachol side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-15
Patient: female
Reactions: Dyspnoea, Heart Rate Decreased
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Pravachol
Possible Pravachol side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-12
Patient: female
Reactions: Heart Rate Decreased, Dyspnoea
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Pravachol
Possible Pravachol side effects in 62 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-12
Patient: 62 year old male
Reactions: Throat Tightness
Drug(s) suspected as cause:
Pravachol
Other drugs received by patient: Toprol-XL; Torsemide; Furosemide; Acetylsalicylic Acid SRT; Imdur; Amitriptyline HCL; Losartan; Amlodipine; Effexor XR; Nasonex; Nitroglycerin; Metformin HCL; Tricor; Plavix; Xanax; Protonix; Flonase; Zofran; Levothyroxine Sodium
Possible Pravachol side effects in 70 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-04
Patient: 70 year old female, weighing 79.8 kg (175.6 pounds)
Reactions: Back Pain, Myalgia, Arthralgia, Sensation of Heaviness, Muscular Weakness, Musculoskeletal Stiffness, Gait Disturbance
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Crestor
Dosage: 1 pill per 1 dy po
Administration route: Oral
Pravachol
Dosage: 1pillper 1 dy po
Administration route: Oral
Indication: Blood Cholesterol Increased
Start date: 1992-01-01
End date: 2012-04-01
Possible Pravachol side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-24
Patient: male
Reactions: Gastrointestinal Haemorrhage
Drug(s) suspected as cause:
Pravachol
Other drugs received by patient: Flexeril; Nexium; Lyrica; Norvasc; Prograf; Duragesic-100; Ursodiol; Amoxicillin; Prednisone; Proair HFA; Sodium Bicarbonate; Albuterol; Dilaudid; Ferrous Gluconate; Catapres; Combivent; Lantus; Lasix; Plavix
Possible Pravachol side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-21
Patient: male, weighing 81.2 kg (178.6 pounds)
Reactions: Myalgia, Pain in Extremity, Arthralgia, Oedema Peripheral, LOW Density Lipoprotein Increased
Drug(s) suspected as cause:
Lipitor
Dosage: 40 mg, daily
Administration route: Oral
Indication: LOW Density Lipoprotein Increased
Start date: 2012-04-09
End date: 2012-04-18
Pravachol
Dosage: unk
Indication: Blood Cholesterol Abnormal
Other drugs received by patient: Plavix
Possible Pravachol side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-15
Patient: male, weighing 81.2 kg (178.6 pounds)
Reactions: Myalgia, Pain in Extremity, Arthralgia, Oedema Peripheral, LOW Density Lipoprotein Increased
Drug(s) suspected as cause:
Lipitor
Dosage: 40 mg, daily
Administration route: Oral
Indication: LOW Density Lipoprotein Increased
Start date: 2012-04-09
End date: 2012-04-18
Pravachol
Dosage: unk
Indication: Blood Cholesterol Abnormal
Other drugs received by patient: Plavix
Possible Pravachol side effects in 70 year old female
Reported by a consumer/non-health professional from United States on 2012-05-15
Patient: 70 year old female, weighing 87.1 kg (191.6 pounds)
Reactions: Interstitial Lung Disease, Liver Disorder
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Pravachol
Dosage: i i po
Administration route: Oral
Indication: Blood Cholesterol Increased
Pravachol
Dosage: i i po
Administration route: Oral
Indication: Blood Cholesterol Increased
Start date: 2011-03-14
End date: 2011-04-11
Possible Pravachol side effects in 46 year old male
Reported by a consumer/non-health professional from United States on 2012-04-27
Patient: 46 year old male, weighing 77.1 kg (169.6 pounds)
Reactions: Muscle Atrophy, Skin Exfoliation, Nervous System Disorder
Drug(s) suspected as cause:
Pravachol
Possible Pravachol side effects in
Reported by a physician from United States on 2012-04-19
Patient:
Reactions: Myalgia, Musculoskeletal Stiffness, Muscular Weakness
Drug(s) suspected as cause:
Crestor
Dosage: unk
End date: 2007-08-04
Lipitor
Dosage: unk
End date: 2007-08-04
Lyrica
Dosage: 75 mg, 2x/day
Administration route: Oral
Paxil
Dosage: unk
End date: 2007-12-07
Pravachol
Dosage: unk
End date: 2007-08-04
Tricor
Dosage: unk
End date: 2007-08-04
Zocor
Dosage: unk
End date: 2007-08-04
Other drugs received by patient: Cymbalta; Savella; Acetylsalicylic Acid; Minocycline Hydrochloride; Calcium; Ciprofloxacin; Januvia; Metformin; Multi-Vitamins; Lovaza; Vitamin B-12; Sotalol Hydrochloride; Losartan; Zetia; Glyburide; Ascorbic Acid; Lantus
Possible Pravachol side effects in 54 year old male
Reported by a consumer/non-health professional from United States on 2012-04-19
Patient: 54 year old male, weighing 86.0 kg (189.2 pounds)
Reactions: Burning Sensation, Hot Flush, Drug Ineffective
Drug(s) suspected as cause:
Mevacor
Indication: Blood Triglycerides Increased
Mevacor
Indication: Blood Cholesterol Increased
Mevacor
Indication: LOW Density Lipoprotein Increased
Niacin
Pravachol
Indication: Blood Cholesterol Increased
Pravachol
Indication: Blood Triglycerides Increased
Pravachol
Indication: LOW Density Lipoprotein Increased
Zocor
Indication: LOW Density Lipoprotein Increased
Zocor
Indication: Blood Triglycerides Increased
Zocor
Indication: Blood Cholesterol Increased
Other drugs received by patient: Xanax
Possible Pravachol side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-18
Patient: female, weighing 90.7 kg (199.5 pounds)
Reactions: Gout, Drug Intolerance, Blood Cholesterol Increased
Drug(s) suspected as cause:
Lipitor
Dosage: unk
Administration route: Oral
Indication: Blood Cholesterol Increased
End date: 2011-01-01
Pravachol
Dosage: 40 mg, unk
Administration route: Oral
Indication: Blood Cholesterol Increased
Pravachol
Dosage: 80 mg, unk
Administration route: Oral
Other drugs received by patient: Lisinopril
Possible Pravachol side effects in 60 year old female
Reported by a consumer/non-health professional from United States on 2012-04-16
Patient: 60 year old female
Reactions: Arthropathy, Nausea
Drug(s) suspected as cause:
Pravachol
Other drugs received by patient: Restasis; Buspirone HCL; Rhinocort; Nexium; Atenolol; Lisinopril; Atrovent; Bentyl; Effexor; Clonazepam
Possible Pravachol side effects in 61 year old female
Reported by a physician from United States on 2012-04-13
Patient: 61 year old female
Reactions: Blood Bilirubin Increased, Portal Hypertension, Jaundice, Abdominal Pain, Liver Injury, Transaminases Increased, Rash Pruritic, Haematemesis, Oedema Peripheral, Dizziness, Erosive Oesophagitis, Gastrooesophageal Reflux Disease, Cough, Fluid Retention, Hiatus Hernia, Vomiting, Excoriation, Nausea, Chromaturia, Ascites, Diarrhoea, Insomnia, Rash Erythematous, Memory Impairment, Gastric Polyps
Drug(s) suspected as cause:
Amoxicillin
End date: 2009-05-06
Pravachol
Start date: 2008-04-01
End date: 2009-05-07
Possible Pravachol side effects in 54 year old male
Reported by a consumer/non-health professional from United States on 2012-04-13
Patient: 54 year old male, weighing 72.6 kg (159.7 pounds)
Reactions: Bedridden, Urine Analysis Abnormal, Respiratory Disorder, Central Nervous System Lesion, Abasia, Muscular Weakness, Deafness, Amnesia, Diplopia, Neuropathy Peripheral, Nervous System Disorder, Dizziness
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Pravachol
Possible Pravachol side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-13
Patient: female
Reactions: Abdominal Pain, Drug Ineffective, Blood Sodium Decreased, Gastrooesophageal Reflux Disease, Discomfort
Drug(s) suspected as cause:
Nexium
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Start date: 2001-01-01
Pravachol
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