Amlodipine / olmesartan Side Effects

Some side effects of amlodipine / olmesartan 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 / olmesartan: oral tablet

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

In rare cases, amlodipine and olmesartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Also call your doctor at once if you have:

• a feeling like you might pass out;

• swelling in your hands or feet, rapid weight gain;

• pounding heartbeats or fluttering in your chest;

• urinating less than usual or not at all;

• jaundice (yellowing of the skin or eyes); or

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

Common side effects include:

• dizziness, drowsiness;

• flushing (warmth, redness, or tingly feeling);

• hair loss; or

• mild skin rash or itching.

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 / olmesartan: oral tablet

Cardiovascular

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 has occurred in up to 10% of patients who are receiving 10 mg doses. Palpitations occur in 1% to 5% 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. Bradycardia, hypotension, and syncope have been reported in less than 1% of patients. Generalized edema has also been reported rarely.

Cardiovascular side effects associated with olmesartan including tachycardia, chest pain, and peripheral edema have been reported in 0.5% to 1% of patients. At least 5 cases of facial edema and at least one case of olmesartan-induced angioedema, which resolved over 7 to 10 days after discontinuing olmesartan, have been reported.

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

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.

Hematologic side effects associated with amlodipine have included isolated cases of thrombocytopenia.

Hematologic side effects associated with olmesartan have included decreased hemoglobin and hematocrit.

Nervous system

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

Nervous system side effects associated with olmesartan have included dizziness (3% vs. 1% with placebo), vertigo (0.5% to 1% with placebo), and insomnia (0.5% to 1% with placebo). Asthenia has been reported in postmarketing experience.

Respiratory

Respiratory side effects associated with olmesartan have included cough (0.9% vs. 0.7% with placebo), bronchitis, rhinitis, pharyngitis, sinusitis, and upper respiratory tract infection.

Hepatic

Hepatic side effects including jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis) have been reported with amlodipine use. In some instances, these cases were severe enough to require hospitalization.

Hepatic side effects associated with olmesartan have rarely included liver enzyme and serum bilirubin elevations.

Metabolic

Metabolic side effects associated with olmesartan have included hyperglycemia and hypertriglyceridemia.

Hypersensitivity

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 side effects including rare cases of angioedema have been reported in patients receiving olmesartan.

Hypersensitivity reactions reported postmarketing have included anaphylactic reactions and peripheral edema.

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.

Other

Calcium channel blockers have been suggested as possibly unsafe in patients with acute porphyria.

Other side effects including a single case of acute porphyria exacerbation have been associated with the use of amlodipine, and confirmed upon rechallenge in the same patient.

Renal

Renal side effects have been reported rarely with amlodipine use. At least one case of interstitial nephritis has been associated with amlodipine therapy.

Renal side effects associated with ACE inhibitors have included increases in serum creatinine or BUN in patients with renal artery stenosis. Acute renal failure and increased serum creatinine levels have been reported in postmarketing experience.

Musculoskeletal

Musculoskeletal side effects including arthralgia, arthritis, myalgia, and skeletal pain have been reported in 0.5% to 1% of patients receiving olmesartan. Rhabdomyolysis has been reported during postmarketing experience in patients receiving angiotensin II receptor blockers.

Gastrointestinal

Gastrointestinal side effects including nausea have been associated with amlodipine in 3% of patients.

Gastrointestinal side effects including abdominal pain, dyspepsia, gastroenteritis, and nausea have been reported in 0.5% to 1% of patients receiving olmesartan. Vomiting has been reported in postmarketing experience. Diarrhea has been reported in more than 1% of patients but at the same or greater incidence than placebo.

Anorexia, constipation, dyspepsia, vomiting, flatulence, and diarrhea have been reported in less than 1% of patients. As with some other calcium channel blockers, rare cases of gingival hyperplasia have been associated with amlodipine. At least one case of amlodipine-associated dysgeusia has been reported and confirmed upon rechallenge.

Dermatologic

Dermatologic side effects including amlodipine-associated lichen planus and telangiectasia have been rarely reported.

Dermatologic side effects associated with olmesartan have included rash (0.5% to 1%), alopecia, pruritus, and urticaria.

Endocrine

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 side effects including a single case of gynecomastia have been associated with the use of amlodipine.

Genitourinary

Genitourinary side effects including gynecomastia have been reported in postmarketing experience with amlodipine.

Genitourinary side effects including urinary tract infection have been reported in 0.5% to 1% of patients receiving olmesartan. Hematuria has been reported in more than 1% of patients but at the same or greater incidence than placebo.

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