Atorvastatin Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 3, 2024.

Applies to atorvastatin: oral suspension, oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol and triglyceride levels and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These may be symptoms of serious muscle problems, such as myopathy or immune-mediated necrotizing myopathy (IMNM).

Call your doctor right away if you have dark-colored urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

Call your doctor right away if you get a headache, stomach pain, vomiting, dark-colored urine, loss of appetite, weight loss, general feeling of tiredness or weakness, light-colored stools, upper right stomach pain, or yellow eyes or skin. These could be symptoms of liver damage.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine if you have a major surgery, major injury, or you develop other serious health problems.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Common side effects of atorvastatin

Some side effects of atorvastatin 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:

Serious side effects of atorvastatin

Along with its needed effects, atorvastatin 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 atorvastatin:

For healthcare professionals

Applies to atorvastatin: oral suspension, oral tablet.

General adverse events

The most common adverse reactions were nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection.^[Ref]

Dermatologic

• Uncommon (0.1% to 1%): Rash, pruritus, urticaria, alopecia
• Rare (0.01% to 0.1%): Angioedema
• Postmarketing reports: Angioneurotic edema, bullous rashes/bullous dermatitis

Bullous rashes/bullous dermatitis included erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Endocrine

• Postmarketing reports: Gynecomastia

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 14.1%)
• Common (1% to 10%): Dyspepsia, nausea, flatulence, constipation
• Uncommon (0.1% to 1%): Abdominal discomfort, abdominal pain, vomiting, upper abdominal pain, lower abdominal pain, pancreatitis, eructation
• Postmarketing reports: Pancreatitis

Genitourinary

• Common (1% to 10%): Urinary tract infection
• Uncommon (0.1% to 1%): Positive for WBCs in urine, erectile dysfunction

Hematologic

• Postmarketing reports: Thrombocytopenia

Hepatic

• Common (1% to 10%): Persistent serum transaminase elevations, abnormal liver function test
• Uncommon (0.1% to 1%): Hepatitis
• Rare (0.01% to 0.1%): Cholestasis
• Frequency not reported: Increased transaminases, abnormal liver function test, jaundice, increased liver enzyme tests, persistent liver enzyme elevations
• Postmarketing reports: Fatal/nonfatal hepatic failure

Persistent elevations in serum transaminases, defined as greater than 3 times the upper limit of normal (3 x ULN) and occurring on at least 2 occasions, occurred in 0.7% of patients who received this drug in clinical trials; these occurred in 0.2%, 0.2%, 0.6%, and 2.3% of patients taking 10, 20, 40, and 80 mg, respectively.

Abnormal liver function test included increased hepatic enzyme, increased ALT, increased AST, increased blood bilirubin, abnormal liver function test, and increased transaminases.

Hypersensitivity

• Common (1% to 10%): Allergic reactions
• Rare (0.01% to 0.1%): Hypersensitivity
• Postmarketing reports: Anaphylaxis

Hypersensitivity included anaphylaxis.

Metabolic

• Common (1% to 10%): Diabetes, hyperglycemia
• Uncommon (0.1% to 1%): Hypoglycemia, anorexia
• Frequency not reported: Increased hemoglobin A1c, increased fasting serum glucose levels

Musculoskeletal

• Very common (10% or more): Arthralgia (up to 11.7%)
• Common (1% to 10%): Pain in extremity, musculoskeletal pain, muscle spasms, myalgia, increased creatine phosphokinase (CPK), joint swelling, back pain
• Uncommon (0.1% to 1%): Neck pain, muscle fatigue
• Rare (0.01% to 0.1%): Immune-mediated necrotizing myopathy, myositis, myopathy, tendinopathy
• Postmarketing reports: Tendon rupture, rhabdomyolysis, lupus-like syndrome, muscle rupture, immune-mediated necrotizing myopathy

Statins:

• Postmarketing reports: Immune-mediated necrotizing myopathy

Elevated CPK (at least 10 x ULN) was higher in the high-dose group (80 mg: 0.3%) compared to the low-dose group (10 mg: 0.1%).

Signs/symptoms of rhabdomyolysis included muscle weakness, muscle swelling, muscle pain, dark urine, myoglobinuria, elevated serum creatine kinase, acute renal failure, and cardiac arrhythmia.

Immune-mediated necrotizing myopathy has been reported rarely with statin use; there have been reports of recurrence when the same or a different statin was administered.

Nervous system

• Common (1% to 10%): Hemorrhagic stroke, headache
• Uncommon (0.1% to 1%): Paresthesia, tinnitus
• Rare (0.01% to 0.1%): Peripheral neuropathy
• Postmarketing reports: Dizziness, peripheral neuropathy, hypoesthesia, amnesia, dysgeusia, myasthenia gravis

Statins:

• Postmarketing reports: Cognitive impairment, new-onset/exacerbation of myasthenia gravis

Hemorrhagic stroke was reported in 2.3% of patients. The incidence of fatal hemorrhagic stroke was similar between this drug and placebo, while the incidence of nonfatal hemorrhagic stroke was significantly greater with this drug.

Cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) has been reported rarely with all statins. Cognitive impairment was generally nonserious and reversible upon statin discontinuation; times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks) were variable.

New-onset or exacerbation of myasthenia gravis (including ocular myasthenia) has been reported rarely with statin use; there have been reports of recurrence when the same or a different statin was administered.

Ocular

• Uncommon (0.1% to 1%): Blurred vision
• Rare (0.01% to 0.1%): Visual disturbance
• Postmarketing reports: Ocular myasthenia

Statins:

• Postmarketing reports: Ocular myasthenia

Other

• Uncommon (0.1% to 1%): Deafness/hearing loss, asthenia, malaise, infection, pyrexia
• Rare (0.01% to 0.1%): Injury
• Frequency not reported: Increased blood alkaline phosphatase
• Postmarketing reports: Fatigue, chest pain, peripheral edema, increased weight

Psychiatric

• Common (1% to 10%): Insomnia
• Uncommon (0.1% to 1%): Nightmare
• Postmarketing reports: Depression

Renal

• Frequency not reported: Acute kidney injury

Acute kidney injury secondary to myoglobinuria and rare fatalities have occurred as a result of rhabdomyolysis in patients treated with this drug.

Respiratory

• Very common (10% or more): Nasopharyngitis (up to 12.9%)
• Common (1% to 10%): Pharyngolaryngeal pain, epistaxis
• Uncommon (0.1% to 1%): Influenza, asthma
• Rare (0.01% to 0.1%): Sinusitis, pharyngitis
• Postmarketing reports: Interstitial lung disease

Exceptional cases of interstitial lung disease (especially with long-term therapy) have been reported with some statins.

See also:

Frequently asked questions

• Can you use limes or lime juice while taking statin drugs (i.e. atorvastatin)?
• Do I need to eat food when taking atorvastatin?
• What are the side effects of statins?
• How long does atorvastatin stay in the system after stopping the drug?
• Do statins help treat COVID-19?
• Can I trust a generic drug manufacturer?

Further information

Atorvastatin side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer