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Pravachol (Pravastatin) - Side Effect Reports to FDA

 
 



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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