Lipitor Side Effects

Generic Name: atorvastatin

Note: This page contains information about the side effects of atorvastatin. Some of the dosage forms included on this document may not apply to the brand name Lipitor.

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

For the Consumer

Applies to atorvastatin: oral tablet

In addition to its needed effects, some unwanted effects may be caused by atorvastatin (the active ingredient contained in Lipitor). In the event that any of these side effects do occur, they may require medical attention.

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

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

In general, atorvastatin (the active ingredient contained in Lipitor) has been well tolerated. Less than 2% of patients in premarketing clinical studies discontinued treatment due to adverse effects.

Gastrointestinal

Gastrointestinal side effects have been the most commonly reported. These have been reported in less than 4% of patients and have included constipation, flatulence, dyspepsia, and abdominal pain. Diarrhea has been reported in up to 5.3% of patients and may be dose-related. Other gastrointestinal side effects observed with HMG-CoA reductase inhibitors have included pancreatitis, anorexia, and vomiting. Most effects tended to be mild and transient.

Hepatic

In clinical trials, liver enzyme elevations returned to pretreatment levels upon discontinuation or dose reduction of atorvastatin (the active ingredient contained in Lipitor) Nawrocki and colleagues reported elevated bilirubin levels in 2/30 patients and elevated AST and ALT levels in 1/30 patients.

Hepatic side effects including altered liver function have been observed with all HMG-CoA reductase inhibitors. In premarketing clinical trials, up to 0.7% of patients experienced persistent, elevated AST and/or ALT values greater than three times the upper normal limits on two or more occasions. Elevations of liver enzymes may be dose-related. Other hepatic side effects of the HMG-CoA class have included hepatitis, cholestatic jaundice, fatty changes in the liver, cirrhosis, fulminant hepatic necrosis, and liver failure.

Musculoskeletal

HMG-CoA reductase inhibitors (statins) have been associated with rare cases of severe myopathy and rhabdomyolysis, accompanied by increases in creatine kinase, myoglobinuria, proteinuria, and renal failure. Concomitant use with gemfibrozil (fibric acid derivatives), niacin, cyclosporine, erythromycin (macrolides) or azole antifungals may increase the incidence and severity of musculoskeletal side effects. Other variables associated with an increased risk of statin-induced myopathy include, advanced age, small body stature, female gender, renal and/or hepatic dysfunction, perioperative periods, hypothyroidism, diabetes mellitus, and alcoholism.

A case of atorvastatin-induced early-onset (after 4 doses) rhabdomyolysis has been reported in a patient with nephrotic syndrome. The authors suggest that the patient's underlying renal dysfunction may have predisposed the patient to rhabdomyolysis.

Musculoskeletal side effects have included uncomplicated myalgia and arthralgia. Milder forms of myotoxicity (i.e., myalgia) are commonly reported and occur in approximately 5% to 7% of patients taking a statin drug. Rhabdomyolysis and myopathy related to HMG-CoA reductase inhibitor use have been reported rarely. One case of atorvastatin-induced dermatomyositis has been reported. Tendon rupture has been reported in postmarketing surveillance.

Hematologic

Hematologic side effects including hemolytic anemia, thrombocytopenia, and leukopenia have occurred with HMG-CoA reductase inhibitors. These effects may be manifestations of a hypersensitivity reaction.

Nervous system

Nervous system side effects of headache and weakness have occurred with HMG-CoA reductase inhibitors. In addition, at least one case of polyneuropathy attributed to atorvastatin (the active ingredient contained in Lipitor) use has also been reported. Other nervous system side effects reported with HMG-CoA reductase inhibitors have included dizziness, drowsiness, fatigue, cranial nerve dysfunction, tremor, vertigo, memory loss, decline in cognitive function, paresthesias, peripheral neuropathy, and peripheral nerve palsy.

Renal

Renal side effects including acute renal failure secondary to rhabdomyolysis have been reported with HMG-CoA reductase inhibitors.

Endocrine

Endocrine side effects associated with the use of other HMG-CoA reductase inhibitors have included hypospermia, gynecomastia, and thyroid dysfunction. In addition, acid maltase deficiency (the genetic disorder also referred to as Pompe's Disease) has been revealed following HMG-CoA therapy in at least one presymptomatic patient.

Hypersensitivity

Hypersensitivity reactions have been observed rarely with HMG-CoA reductase inhibitors. Symptoms have included anaphylaxis, angioedema, allergic reaction, urticaria, fever, chills, flushing, malaise and dyspnea. Bullous rashes including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have occurred.

Psychiatric

Psychiatric side effects of HMG-CoA reductase inhibitors have included decreases in libido, anxiety, depression, and insomnia. In addition, nightmares have been associated with atorvastatin (the active ingredient contained in Lipitor) use. Psychiatric side effects reported postmarketing have included cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).

Genitourinary

A 77-year-old female with a history of hypercholesterolemia experienced hemorrhagic cystitis coincident with atorvastatin (the active ingredient contained in Lipitor) therapy. She presented with gross hematuria of approximately 4 weeks duration. She had been given atorvastatin 5 mg daily approximately 1 week before the onset of her hematuria. Urinalysis showed grossly bloody urine with too-numerous-to-count red cells on microscopic examination. Biopsy of the affected areas of the bladder showed congestion of superficial mucosal vessels and mild infiltration of the epithelium and lamina propria with polymorphonuclear leukocytes and lymphocytes, consistent with benign, acute, and chronic inflammatory process. The patient discontinued atorvastatin therapy but continued with her other medication regimen. Her hematuria resolved within 1 week of discontinuing therapy with atorvastatin. At the insistence of her prescriber, she once again was given atorvastatin, with a rapid recurrence of her hematuria. She once again discontinued atorvastatin, and her hematuria rapidly resolved.

Genitourinary adverse effects associated with other HMG-CoA reductase inhibitors have included erectile dysfunction, impotence, and testicular pain. At least one case of hemorrhagic cystitis has been reported.

Dermatologic

Dermatologic reactions have occurred rarely. In premarketing trials, up to 3.8% of patients complained of a rash. Phototoxicity has been associated with atorvastatin (the active ingredient contained in Lipitor) A case of dermatomyositis has also been reported.

Cardiovascular

Analysis of study data has shown an increased risk of hemorrhagic stroke in patients treated with atorvastatin (the active ingredient contained in Lipitor) who had a stroke or TIA within 6 months preceding treatment compared to placebo.

Cardiovascular side effects occurring since market introduction have included angioneurotic edema, peripheral edema, and chest pain. Atorvastatin may also increase the incidence of hemorrhagic stroke in patients with a history of recent stroke or TIA.

Respiratory

Respiratory symptoms reported since market introduction have included bronchitis, rhinitis, pharyngitis, and sinusitis.

Ocular

Ocular side effects including a case of reversible ophthalmoplegia as well as a case of ocular myasthenia have been reported.

A 60-year-old woman with hypercholesterolemia treated with atorvastatin developed painless horizontal diplopia, vertigo, blurry vision, elevated anti-acetylcholine receptor (anti-AchR) antibodies levels, ataxia, and paresthesia of the upper extremities. No other medications were reported. Neurological exam revealed generalized hyperreflexia and finger-nose and gait ataxia. Ptosis was present in both upper eyelids. Discontinuation of atorvastatin resulted in symptom resolution and anti-AchR levels within normal limits.

A 67-year-old women treated for hypercholesterolemia with atorvastatin developed myogenic ptosis and variable incomitant horizontal and vertical strabismus consistent with ocular myasthenia. Following discontinuation of atorvastatin, the patient experienced significant clinical improvement with only mild residual aponeurotic ptosis after 2 months.

Immunologic

Immunologic side effects including a possible case of atorvastatin-induced reversible positive antinuclear antibodies have been reported.

Other

Other side effects reported during clinical trials (in more than 2% of patients) have included infection, accidental injury, flu syndrome, abdominal pain, and back pain. Other side effects reported postmarketing have included anaphylaxis, angioneurotic edema, bullous rashes (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), rhabdomyolysis, fatigue, tendon rupture, fatal and nonfatal hepatic failure, dizziness, depression, peripheral neuropathy, and pancreatitis.

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