Note: This document contains side effect information about pravastatin. Some dosage forms listed on this page may not apply to the brand name Pravachol.
Summary
More frequent 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]
