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Pravastatin Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 13, 2021.

Summary

More frequently reported side effects include: increased serum alanine aminotransferase, skin rash, and increased creatine phosphokinase in blood specimen. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to pravastatin: oral tablets

Side effects include:

Musculoskeletal pain, nausea or vomiting, upper respiratory infection, diarrhea, headache.

For Healthcare Professionals

Applies to pravastatin: oral tablet

General

The most frequently reported side effects were musculoskeletal pain, nausea/vomiting, upper respiratory tract infection, diarrhea, and headache.[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (up to 24.9%), musculoskeletal traumatism (10.2%)

Common (1% to 10%): Myalgia, muscle cramp, arthralgia

Uncommon (0.1% to 1%): Muscle weakness

Postmarketing reports: Myopathy, rhabdomyolysis, immune-mediated necrotizing myopathy, lupus erythematosus-like syndrome, polymyalgia rheumatica, arthritis, myositis, polymyositis, tendon disorder[Ref]

Gastrointestinal

Very common (10% or more): Nausea/vomiting (up to 10.5%)

Common (1% to 10%): Diarrhea, flatulence, dyspepsia/heartburn, abdominal distension, constipation

Uncommon (0.1% to 1%): Abdominal pain

Postmarketing reports: Pancreatitis[Ref]

Other

Very common (10% or more): Chest pain (up to 10%)

Common (1% to 10%): Fatigue, influenza, creatinine phosphokinase increased, edema, fever, weight gain, weight loss, viral infection

Uncommon (0.1% to 1%): Edema, weakness, hearing loss, tinnitus

Frequency not reported: Head/neck edema, vertigo

Postmarketing reports: Chills, asthenia[Ref]

Hepatic

Common (1% to 10%): ALT increased, GGT increased, AST increased

Postmarketing reports: Hepatitis, chronic active hepatitis, cholestatic jaundice, fatty change in liver, cirrhosis, fulminant hepatic necrosis, fatal hepatic failure, nonfatal hepatic failure, liver function test abnormalities[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, paresthesia

Uncommon (0.1% to 1%): Numbness

Frequency not reported: Memory impairment, neuropathy/peripheral neuropathy, taste disturbance

Postmarketing reports: Intraocular movement impaired, facial paresis, peripheral nerve palsy, cognitive impairment, forgetfulness, amnesia[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 21.2%)

Common (1% to 10%): Pharyngitis, rhinitis, cough, pulmonary infection, sinus abnormality/sinusitis, tracheobronchitis, dyspnea

Frequency not reported: Interstitial lung disease[Ref]

Dermatologic

Common (1% to 10%): Rash, dermatitis

Uncommon (0.1% to 1%): Pruritus, urticaria, scalp/hair abnormality, alopecia

Postmarketing reports: Skin discoloration, skin nodules, dry mucous membranes, changes to hair/nails, angioedema, dermatomyositis, purpura, photosensitivity, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome[Ref]

Cardiovascular

Common (1% to 10%): Angina pectoris

Uncommon (0.1% to 1%): Disturbance of rhythm, hypertension, myocardial infarction

Frequency not reported: Flushing

Postmarketing reports: Vasculitis[Ref]

Ocular

Common (1% to 10%): Blurred vision, diplopia

Uncommon (0.1% to 1%): Eye inflammation, lens opacity[Ref]

Psychiatric

Common (1% to 10%): Sleep disturbance, anxiety/nervousness, depression

Uncommon (0.1% to 1%): Insomnia

Frequency not reported: Libido change[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection

Uncommon (0.1% to 1%): Dysuria, urinary frequency, nocturia, sexual dysfunction[Ref]

Endocrine

Postmarketing reports: Thyroid function abnormalities, gynecomastia[Ref]

Hematologic

Postmarketing reports: Hemolytic anemia, erythrocyte sedimentation rate increased, transient asymptomatic eosinophilia[Ref]

Immunologic

Frequency not reported: Allergic/hypersensitivity reaction

Postmarketing reports: Anaphylaxis, positive antinuclear antibodies[Ref]

Oncologic

Postmarketing reports: Hepatoma[Ref]

Frequently asked questions

References

1. "Product Information. Pravachol (pravastatin)." Bristol-Myers Squibb (2001):

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.