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. Continue reading for a comprehensive list of adverse effects.
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]
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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.