Pravastatin Side Effects

In Summary

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

For the Consumer

Applies to pravastatin: oral tablet

As well as its needed effects, pravastatin may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking pravastatin, check with your doctor immediately:

More common:

• Difficulty with moving
• muscle or bone pain
• muscle stiffness
• pain in the joints
• pain, localized

Less common:

• Arm, back, or jaw pain
• chest pain or discomfort
• chills
• cough
• dark-colored urine
• diarrhea
• difficult or labored breathing
• ear congestion
• fast or irregular heartbeat
• fever
• general feeling of discomfort or illness
• headache
• loss of appetite
• muscle cramps or spasms
• muscular tenderness, wasting, or weakness
• nasal congestion
• nausea
• runny nose
• shivering
• sneezing
• sore throat
• sweating
• swollen joints
• tightness in the chest
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Minor Side Effects

Some pravastatin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:

• Stomach pain

Less common:

• Acid or sour stomach
• belching
• bloated or full feeling
• blurred vision or other changes in vision
• difficult or painful urination
• difficulty having a bowel movement (stool)
• dizziness
• double vision
• fear or nervousness
• feeling sad or empty
• increased urge to urinate during the night
• irritability
• loss of interest or pleasure
• pain in the chest below the breastbone
• passing gas
• rash
• stomach discomfort or upset
• tiredness
• trouble concentrating

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]

It is possible that some side effects of pravastatin may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.