Amlodipine / atorvastatin Side Effects

Some side effects of amlodipine / atorvastatin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to amlodipine / atorvastatin: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking amlodipine / atorvastatin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using amlodipine and atorvastatin and call your doctor at once if you have:

• unexplained muscle pain, tenderness, or weakness;

• fever, unusual tiredness, and dark colored urine;

• swelling, weight gain, urinating less than usual or not at all;

• severe drowsiness, feeling like you might pass out;

• pounding heartbeats or fluttering in your chest;

• worsening chest pain;

• chest pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• headache;

• mild muscle pain;

• diarrhea;

• mild nausea;

• stomach pain or indigestion;

• dizziness;

• joint pain; or

• flushing (warmth or redness in your face).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to amlodipine / atorvastatin: oral tablet

Cardiovascular

Worsened angina has been rarely associated with the use of amlodipine (as with other calcium channel blockers).

Bradycardia, hypotension, and syncope have been reported in less than 1% of patients receiving amlodipine.

Cardiovascular side effects associated with amlodipine are dose-related, are usually the result of vasodilation, and include flushing in less than 1% and peripheral edema in 2% of patients. Peripheral edema may become a chronic problem, and may occur in up to 10% of patients who are receiving 10 mg doses. Palpitations occur 1% to 5% (10 mg) of patients. Recent data have shown that the use of amlodipine in patients with NYHA Class III or IV heart failure is not associated with worsened heart failure.

Cardiovascular side effects occurring since market introduction of atorvastatin 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.

Endocrine

Endocrine side effects including a single case of gynecomastia has been associated with the use of amlodipine. The patient's gynecomastia resolved upon substitution of amlodipine with an unrelated antihypertensive agent. The use of amlodipine has not been associated with adverse effects on glucose metabolism or serum lipids.

Endocrine adverse effects associated with the use of other HMG-CoA reductase inhibitors have included hypospermia, gynecomastia and thyroid dysfunction.

Gastrointestinal

Gastrointestinal side effects associated with amlodipine include nausea in 3% of patients.

Gastrointestinal symptoms have been the most common adverse effects and have included constipation, flatulence, dyspepsia and abdominal pain. These effects occurred in less than 4% of patients. Diarrhea has been reported in up to 5.3% of patients and may be dose-related.

Anorexia, constipation, dyspepsia, vomiting, flatulence, and diarrhea have been reported in less than 1% of patients receiving amlodipine. As with some other calcium channel blockers, rare cases of gingival hyperplasia have been associated with amlodipine.

Other gastrointestinal side effects observed with HMG-CoA reductase inhibitors have included pancreatitis, anorexia and vomiting. Most effects tended to be mild and transient.

Hematologic

A case study reports a 34-year-old woman with a history of chronic renal failure secondary to glomerulonephritis, who was started on amlodipine for uncontrolled hypertension. Three days later the patient developed severe thrombocytopenia. After discontinuation of the drug, the platelet count returned to normal.

Hematological side effects have included isolated cases of thrombocytopenia during amlodipine therapy.

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.

Hypersensitivity

A 62-year-old man with hypertension and psoriasis developed erythema multiforme within three days after starting amlodipine. The rash resolved upon substitution with nifedipine.

Hypersensitivity reactions have rarely been reported, although experience with amlodipine is limited. A single case of erythema multiforme during amlodipine therapy has been reported.

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.

Nervous system

Nervous system side effects associated with amlodipine include headache in 8%, dizziness in 3%, and fatigue in 5% of patients. Vertigo, tremors, and paresthesias have been reported in less than 1% of patients receiving amlodipine.

Nervous system side effects of headache and weakness have occurred with HMG-CoA reductase inhibitors.

Other

A single case of acute porphyria exacerbation has been associated with the use of amlodipine, and confirmed upon rechallenge in the same patient. Calcium channel blockers have been suggested as possibly unsafe in patients with this condition.

Other side effects reported during clinical trials with atorvastatin (in greater than or equal to 2% of patients) include infection, accidental injury, flu syndrome, abdominal pain and back pain. Fatigue has also been reported in postmarketing studies with atorvastatin.

Edema, flushing, palpitations, and somnolence appear to be more common in women than in men.

Dermatologic

Dermatologic reactions have occurred rarely during atorvastatin therapy. In premarketing trials up to 3.8% of patients complained of a rash. Since market introduction, bullous rashes including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have occurred.

General

Atorvastatin generally has been well tolerated. Less than 2% of patients in premarketing clinical studies discontinued treatment due to adverse effects.

Genitourinary

Genitourinary adverse effects associated with other HMG-CoA reductase inhibitors have included erectile dysfunction and impotence. Gynecomastia has been reported in postmarketing experience with amlodipine, although causality has not been determined.

Immunologic

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

Psychiatric

Psychiatric side effects of HMG-CoA reductase inhibitors have included decreases in libido, anxiety, depression and insomnia.

Renal

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

Respiratory

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

Hepatic

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 and fulminant hepatic necrosis.

In clinical trials, liver enzyme elevations returned to pretreatment levels upon discontinuation or dose reduction of atorvastatin. Liver function tests should be closely monitored as most patients remain asymptomatic with elevated liver enzymes. Treatment should be discontinued if values remain elevated. Nawrocki and colleagues reported elevated bilirubin levels in 2/30 patients and elevated AST and ALT levels in 1/30 patients.

Musculoskeletal

Some drugs in the HMG-CoA reductase inhibitor class have been associated with rare cases of severe myopathy and rhabdomyolysis, accompanied by increases in creatine kinase, myoglobinuria, proteinuria and renal failure. The risk of myopathy is increased with concurrent administration of cyclosporine, fibric acid derivatives, erythromycin, niacin, or azole antifungals.

Patients should be instructed to promptly report symptoms of muscle pain, weakness, or tenderness. If such symptoms develop, creatine kinase should be measured, and if markedly elevated, atorvastatin should be discontinued. The value of routine creatine kinase monitoring is not known.

Musculoskeletal side effects have included uncomplicated myalgia and arthralgia during atorvastatin therapy. 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 also been reported in postmarketing studies.

In addition, some data have suggested that exposure to HMG-CoA reductase inhibitors is associated with a decreased risk of bone fractures in persons older than 50 years of age.

Ocular

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

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.

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