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Amlodipine / olmesartan Side Effects

Not all side effects for amlodipine / olmesartan 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 amlodipine / olmesartan: oral tablet

In addition to its needed effects, some unwanted effects may be caused by amlodipine / olmesartan. 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 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
  • Abdominal or stomach pain
  • dark urine
  • decreased urine output
  • diarrhea
  • fever
  • itching skin or 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
  • upper right abdominal or stomach pain
  • yellow eyes or skin

Some of the side effects that can occur with amlodipine / olmesartan 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:

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

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]

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

Nervous system

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

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]

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

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]

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]

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

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

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

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Azor (amlodipine-olmesartan)." Daiichi Pharmaceuticals, Montvale, NJ.

3. Cerner Multum, Inc. "Australian Product Information." O 0

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