Applies to amlodipine / olmesartan: oral tablet.

Serious side effects

Along with its needed effects, amlodipine/olmesartan 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 amlodipine / olmesartan:

More common

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• rapid weight gain

Less common

• Fast, irregular, pounding, or racing heartbeat or pulse
• unusual tiredness or weakness

Incidence not known

• Dark urine
• decreased urine output
• diarrhea
• fever
• itching, skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• muscle pain or stiffness
• stomach pain
• upper right abdominal or stomach pain
• yellow eyes or skin

Other side effects

Some side effects of amlodipine / olmesartan 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:

Less common

• Dizziness
• feeling of warmth
• redness of the face, neck, arms, and occasionally, upper chest
• sleepiness or unusual drowsiness

Incidence not known

• Hives or welts
• redness of the skin

For Healthcare Professionals

Applies to amlodipine / olmesartan: oral tablet.

General

The most common adverse reaction is edema.^[Ref]

Other

There was a greater incidence of edema in women (14.6%) than men (5.6%).^[Ref]

Very common (10% or more): Edema (up to 13.3%)

Common (1% to 10%): Fatigue, peripheral edema, pitting edema

Uncommon (0.1% to 1%): Asthenia

Rare (less than 0.1%): Face edema

Amlodipine:

Very common (10% or more): Edema (up to 24.5%)

Common (1% to 10%): Fatigue, peripheral edema

Uncommon (0.1% to 1%): Asthenia, chest pain, malaise, pain, pitting edema, gynecomastia

Olmesartan:

Common (1% to 10%): Chest pain, fatigue, influenza-like symptoms, pain, peripheral edema, edema

Uncommon (0.1% to 1%): Asthenia, face edema, malaise, pitting edema^[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache

Uncommon (0.1% to 1%): Hypoesthesia, lethargy, paresthesia, postural dizziness, vertigo

Rare (less than 0.1%): Syncope

Amlodipine:

Common (1% to 10%): Dizziness, headache, somnolence

Uncommon (0.1% to 1%): Dysgeusia, hypoesthesia, paresthesia, syncope, tremor, tinnitus, postural dizziness, vertigo, peripheral neuropathy

Very rare (less than 0.01%): Hypertonia

Frequency not reported: Extrapyramidal syndrome, ataxia, migraine, amnesia, parosmia

Olmesartan:

Common (1% to 10%): Dizziness, headache

Uncommon (0.1% to 1%): Vertigo

Rare (less than 0.1%): Lethargy^[Ref]

There was a greater incidence of somnolence in women (1.6%) than men (1.3%).^[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Constipation, diarrhea, dry mouth, dyspepsia, nausea, upper abdominal pain, vomiting

Amlodipine:

Common (1% to 10%): Abdominal pain, nausea

Uncommon (0.1% to 1%): Altered bowel habits, dry mouth, dyspepsia, vomiting, constipation, dysphagia, diarrhea, flatulence, pancreatitis, gingival hyperplasia

Very rare (less than 0.01%): Gastritis

Frequency not reported: Loose stools

Olmesartan:

Common (1% to 10%): Abdominal pain, diarrhea, dyspepsia, gastroenteritis, nausea

Uncommon (0.1% to 1%): Vomiting

Very rare (less than 0.01%): Sprue-like enteropathy^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Palpitations, tachycardia, hypotension, orthostatic hypotension, hypertension

Rare (less than 0.1%): Flushing

Amlodipine:

Common (1% to 10%): Flushing, palpitation

Uncommon (0.1% to 1%): Angina pectoris, hypotension, peripheral ischemia, tachycardia, postural hypotension, hot flushes, vasculitis

Very rare (less than 0.01%): Arrhythmia, myocardial infarction

Frequency not reported: Cardiac failure, pulse irregularity, extrasystoles

Olmesartan:

Uncommon (0.1% to 1%): Angina pectoris, hypertension, tachycardia

Rare (less than 0.1%): Hypotension^[Ref]

There was a greater incidence of flushing and palpitation in women than men. The incidence of flushing was 4.5% in females and 1.5% in males. The incidence of palpitation was 3.3% in females and 1.4% in males.^[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Back pain, muscle spasm, pain in extremity

Amlodipine:

Common (1% to 10%): Ankle swelling

Uncommon (0.1% to 1%): Arthralgia, back pain, muscle spasm, myalgia, rigors, arthrosis, muscle cramps

Frequency not reported: Muscle weakness, twitching

Olmesartan:

Common (1% to 10%): Arthritis, back pain, skeletal pain, blood creatine phosphokinase increased

Uncommon (0.1% to 1%): Myalgia, arthralgia

Rare (less than 0.1%): Muscle spasm

Frequency not reported: Rhabdomyolysis^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Pollakiuria, erectile dysfunction/impotence

Amlodipine:

Uncommon (0.1% to 1%): Increased urinary frequency, micturition disorder, nocturia, erectile dysfunction/impotence, gynecomastia, sexual dysfunction

Frequency not reported: Dysuria, polyuria

Olmesartan:

Common (1% to 10%): Hematuria, urinary tract infection^[Ref]

Metabolic

Uncommon (0.1% to 1%): Hyperkalemia, blood potassium decreased

Amlodipine:

Uncommon (0.1% to 1%): Weight decreased, weight increased, anorexia, thirst, hyperglycemia

Frequency not reported: Increased appetite

Olmesartan:

Common (1% to 10%): Hypertriglyceridemia, hyperuricemia, hyperglycemia

Rare (less than 0.1%): Hyperkalemia^[Ref]

Respiratory

Uncommon (0.1% to 1%): Cough, dyspnea

Amlodipine:

Uncommon (0.1% to 1%): Dyspnea, rhinitis, epistaxis

Very rare (less than 0.01%): Cough

Olmesartan:

Common (1% to 10%): Bronchitis, cough, pharyngitis, rhinitis, sinusitis^[Ref]

Renal

Uncommon (0.1% to 1%): Blood creatinine increased, blood uric acid increased

Olmesartan:

Common (1% to 10%): Blood urea increased

Rare (less than 0.1%): Acute renal failure, renal insufficiency, blood creatinine increased^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash

Rare (less than 0.1%): Urticaria

Amlodipine:

Uncommon (0.1% to 1%): Alopecia, exanthema, hyperhidrosis, pruritus, purpura, rash, skin discoloration, sweating increased, angioedema, rash erythematous, rash maculopapular

Very rare (less than 0.01%): Angioneurotic edema, erythema multiforme, exfoliative dermatitis, photosensitivity, Quincke edema, Stevens-Johnson syndrome, urticaria

Frequency not reported: Skin dryness, dermatitis, cold and clammy skin

Olmesartan:

Uncommon (0.1% to 1%): Allergic dermatitis, exanthema, pruritus, rash, urticaria

Rare (less than 0.1%): Angioneurotic edema

Postmarketing reports: Angioedema, alopecia^[Ref]

Psychiatric

Uncommon (0.1% to 1%): Libido decreased

Amlodipine:

Uncommon (0.1% to 1%): Depression, insomnia, irritability, mood changes, sleep disorder, nervousness, abnormal dreams, anxiety, depersonalization

Rare (less than 0.1%): Confusion

Frequency not reported: Apathy, agitation^[Ref]

Hepatic

Uncommon (0.1% to 1%): GGT increased

Amlodipine:

Very rare (less than 0.01%): Hepatic enzymes increased, hepatitis, jaundice

Olmesartan:

Common (1% to 10%): Hepatic enzymes increased^[Ref]

Immunologic

Rare (less than 0.1%): Allergic reaction/drug hypersensitivity

Amlodipine:

Uncommon (0.1% to 1%): Allergic reactions

Very rare (less than 0.01%): Allergic reaction/drug hypersensitivity

Olmesartan:

Uncommon (0.1% to 1%): Anaphylactic reaction^[Ref]

Ocular

Amlodipine:

Uncommon (0.1% to 1%): Visual disturbance, abnormal vision, conjunctivitis, diplopia, eye pain

Frequency not reported: Xerophthalmia^[Ref]

Hematologic

Frequency not reported: Hemoglobin decreased, hematocrit decreased

Amlodipine:

Uncommon (0.1% to 1%): Leukopenia, thrombocytopenia

Olmesartan:

Uncommon (0.1% to 1%): Thrombocytopenia^[Ref]