Atorvastatin Side Effects

Commonly reported side effects of atorvastatin include: arthralgia,

diarrhea, and nasopharyngitis. Other side effects include: urinary tract
infection, insomnia, limb pain, muscle spasm, musculoskeletal pain, myalgia,
and nausea. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to atorvastatin: oral tablet
In addition to its needed effects, some unwanted effects may be caused by
atorvastatin. In the event that any of these side effects do occur, they may
require medical attention.
Major Side Effects

You should check with your doctor immediately if any of these side
effects occur when taking atorvastatin:
Less common or rare:

Cough

difficulty with swallowing

dizziness

fast heartbeat

fever

hives

itching

muscle cramps, pain, stiffness, swelling, or weakness

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

skin rash

tightness in the chest

unusual tiredness or weakness

wheezing

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

Minor Side Effects

Some of the side effects that can occur with atorvastatin may not need
medical attention. As your body adjusts to the medicine during treatment
these side effects may go away. Your health care professional may also be
able to tell you about ways to reduce or prevent some of these side effects. If
any of the following side effects continue, are bothersome or if you have any
questions about them, check with your health care professional:
More common:

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:

Abdominal or stomach pain

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

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

For Healthcare Professionals

Applies to atorvastatin: oral tablet
General

The most frequently reported side effects were nasopharyngitis, arthralgia,

diarrhea, pain in extremity, and urinary tract infection.[Ref]
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, eructation, abdominal pain,
vomiting, pancreatitis[Ref]

Hepatic

Common (1% to 10%): Blood bilirubin increased, ALT increased,

transaminases/hepatic enzymes increased, AST increased, liver function test
abnormal, blood alkaline phosphatase increased
Uncommon (0.1% to 1%): Hepatitis
Rare (0.01% to 0.1%): Cholestasis
Very rare (less than 0.1%): Fatal hepatic failure, nonfatal hepatic failure [Ref]
Musculoskeletal

Very common (10% or more): Arthralgia (up to 11.7%)

Common (1% to 10%): Pain in extremity, musculoskeletal pain, muscle
spasms, myalgia, joint swelling, back pain, creatine phosphokinase increased
Uncommon (0.1% to 1%): Neck pain, muscle fatigue
Rare (less than 0.1%): Myositis, myopathy, rhabdomyolysis, tendinopathy
Frequency not reported: Immune-mediated necrotizing myopathy
Postmarketing reports: Tendon rupture[Ref]
Hematologic

Rare (less than 0.1%): Thrombocytopenia[Ref]

Nervous system

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Paresthesia, dizziness, hypoesthesia, dysgeusia,
amnesia
Rare (less than 0.1%): Peripheral neuropathy
Frequency not reported: Nonfatal hemorrhagic stroke
Postmarketing reports: Cognitive impairment, memory loss, forgetfulness,
memory impairment[Ref]
Endocrine

Very rare (less than 0.01%): Gynecomastia[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reactions

Rare (less than 0.1%): Anaphylaxis, hypersensitivity reaction[Ref]

Psychiatric

Common (1% to 10%): Insomnia

Uncommon (0.1% to 1%): Nightmare
Postmarketing reports: Confusion, depression[Ref]
Genitourinary

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

Uncommon (0.1% to 1%): White blood cells urine positive, erectile
dysfunction[Ref]
Dermatologic

Uncommon (0.1% to 1%): Rash, pruritus, urticaria, alopecia

Rare (less than 0.1%): Angioneurotic edema/angioedema, bullous rashes,
erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis
Frequency not reported: Urticaria[Ref]
Cardiovascular

Common (1% to 10%): Cardiovascular death[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (up to 12.9%)

Common (1% to 10%): Pharyngolaryngeal pain, epistaxis
Uncommon (0.1% to 1%): Asthma
Rare (less than 0.1%): Sinusitis, pharyngitis
Frequency not reported: Interstitial lung disease[Ref]
Ocular

Uncommon (0.1% to 1%): Vision blurred

Rare (less than 0.1%): Visual disturbance[Ref]
Other

Common (1% to 10%): Non-cardiovascular death

Uncommon (0.1% to 1%): Deafness, tinnitus, malaise, asthenia, influenza,
infection, chest pain, peripheral edema, fatigue, pyrexia

Rare (0.01% to 0.1%): Injury

Very rare (less than 0.01%): Hearing loss[Ref]
Metabolic

Common (1% to 10%): Hyperglycemia

Uncommon (0.1% to 1%): Anorexia, hypoglycemia, weight increased
Frequency not reported: Diabetes mellitus[Ref]
References
1. "Product Information. Lipitor (atorvastatin)." Parke-Davis, Morris Plains, NJ.
2. Cerner Multum, Inc. "Australian Product Information." O 0
3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Not all side effects for atorvastatin may be reported. You should always
consult a doctor or healthcare professional for medical advice. Side effects
can be reported to the FDA.