Atorvastatin Side Effects

Applies to atorvastatin: oral suspension, oral tablet.

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:

More common side effects

• headache
• hoarseness
• lower back or side pain
• pain or tenderness around the eyes and cheekbones
• painful or difficult urination
• stuffy or runny nose

Less common side effects

• back pain
• belching or excessive gas
• constipation
• general feeling of discomfort or illness
• heartburn, indigestion, or stomach discomfort
• lack or loss of strength
• loss of appetite
• nausea
• shivering
• stomach pain
• sweating
• trouble sleeping
• vomiting

Incidence not known

• appetite increased
• black, tarry stools
• bloody nose
• bloody or cloudy urine
• blurred vision
• continuing ringing or buzzing or other unexplained noise in the ears
• difficult, burning, or painful urination
• difficulty seeing at night
• excessive muscle tone or tension
• fruit-like breath odor
• groin or scrotum pain
• inability to have or keep an erection
• increased body movements
• increased sensitivity of the eyes to light
• increased sensitivity to touch or pain
• increased thirst
• increased urination
• loss of bladder control
• loss of sexual ability, drive, or desire
• menstrual bleeding occurring earlier or lasting longer than usual
• mental depression
• nervousness
• nightmares
• pale skin
• paranoia
• pinpoint red spots on the skin
• slurred speech
• swollen or tender lymph glands in the neck, armpit, or groin
• unable to move or feel face
• unusual bleeding or bruising
• weight loss

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:

Less common or rare side effects

• chest tightness
• cough
• difficulty with swallowing
• dizziness
• fast heartbeat
• fever
• hives, itching, skin rash
• muscle cramps, pain, stiffness, swelling, or weakness
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• unusual tiredness or weakness

Incidence not known

• blistering, peeling, or loosening of the skin
• chills
• dark-colored urine
• diarrhea
• joint pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• red skin lesions, often with a purple center sore
• red, irritated eyes
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips

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.

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