Pravastatin Sodium

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.

Applies to pravastatin: oral tablet

Along with its needed effects, pravastatin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking pravastatin:

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

Some side effects of pravastatin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions 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

Applies to pravastatin: oral tablet

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

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

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

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

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

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

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

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

Common (1% to 10%): Angina pectoris

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

Frequency not reported: Flushing

Postmarketing reports: Vasculitis

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

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

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

Uncommon (0.1% to 1%): Insomnia

Frequency not reported: Libido change

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

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

Postmarketing reports: Thyroid function abnormalities, gynecomastia

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

Frequency not reported: Allergic/hypersensitivity reaction

Postmarketing reports: Anaphylaxis, positive antinuclear antibodies

Postmarketing reports: Hepatoma