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Azor Side Effects

Generic Name: amlodipine / olmesartan

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

Not all side effects for Azor 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


The most common adverse reaction is edema.[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

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

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

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

Common (1% to 10%): Dizziness, headache
Uncommon (0.1% to 1%): Vertigo
Rare (less than 0.1%): Lethargy[Ref]


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

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

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]


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

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

Uncommon (0.1% to 1%): Angina pectoris, hypertension, tachycardia
Rare (less than 0.1%): Hypotension[Ref]


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

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

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]


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

Uncommon (0.1% to 1%): Increased urinary frequency, micturition disorder, nocturia, erectile dysfunction/impotence, gynecomastia, sexual dysfunction
Frequency not reported: Dysuria, polyuria

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


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

Uncommon (0.1% to 1%): Weight decreased, weight increased, anorexia, thirst, hyperglycemia
Frequency not reported: Increased appetite

Common (1% to 10%): Hypertriglyceridemia, hyperuricemia, hyperglycemia
Rare (less than 0.1%): Hyperkalemia[Ref]


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

Uncommon (0.1% to 1%): Dyspnea, rhinitis, epistaxis
Very rare (less than 0.01%): Cough

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


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

Common (1% to 10%): Blood urea increased
Rare (less than 0.1%): Acute renal failure, renal insufficiency, blood creatinine increased[Ref]


Uncommon (0.1% to 1%): Rash
Rare (less than 0.1%): Urticaria

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

Uncommon (0.1% to 1%): Allergic dermatitis, exanthema, pruritus, rash, urticaria
Rare (less than 0.1%): Angioneurotic edema
Postmarketing reports: Angioedema, alopecia[Ref]


Uncommon (0.1% to 1%): Libido decreased

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]


Uncommon (0.1% to 1%): GGT increased

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

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


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

Uncommon (0.1% to 1%): Allergic reactions
Very rare (less than 0.01%): Allergic reaction/drug hypersensitivity

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


Uncommon (0.1% to 1%): Visual disturbance, abnormal vision, conjunctivitis, diplopia, eye pain
Frequency not reported: Xerophthalmia[Ref]


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

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


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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