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]