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Amlodipine / hydrochlorothiazide / olmesartan Side Effects

For the Consumer

Applies to amlodipine / hydrochlorothiazide / olmesartan: oral tablet

In addition to its needed effects, some unwanted effects may be caused by amlodipine / hydrochlorothiazide / olmesartan. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking amlodipine / hydrochlorothiazide / olmesartan:

More common:
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • rapid weight gain
  • tingling of the hands or feet
  • unusual weight gain or loss
Less common:
  • Bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • cough
  • difficult, burning, or painful urination
  • difficulty with breathing
  • fainting
  • frequent urge to urinate
  • headache
  • loss of voice
  • lower back or side pain
  • swelling of the joints
  • unusual tiredness or weakness

Minor Side Effects

Some of the side effects that can occur with amlodipine / hydrochlorothiazide / 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:
  • Diarrhea
  • muscle aches or spasms
  • nausea

For Healthcare Professionals

Applies to amlodipine / hydrochlorothiazide / olmesartan: oral tablet


The most common adverse reactions were dizziness, peripheral edema, and headache.[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache, syncope
Uncommon (0.1% to 1%): Hypoesthesia, lethargy, paresthesia, postural dizziness, vertigo

Common (1% to 10%): Dizziness, headache, somnolence
Uncommon (0.1% to 1%): Hypoesthesia, paresthesia, syncope, tremor, tinnitus, postural dizziness, peripheral neuropathy
Rare (less than 0.1%): Hypertonia, ataxia, migraine, amnesia, parosmia, taste perversion

Frequency not reported: Lightheadedness, vertigo, paresthesia

Common (1% to 10%): Dizziness, headache
Uncommon (0.1% to 1%): Vertigo
Postmarketing reports: Lethargy[Ref]


Common (1% to 10%): Nausea, diarrhea
Uncommon (0.1% to 1%): Constipation, dry mouth, dyspepsia, upper abdominal pain, vomiting

Common (1% to 10%): Abdominal pain, nausea, dyspepsia
Uncommon (0.1% to 1%): Altered bowel habits, dry mouth, vomiting, constipation, dysphagia, diarrhea, flatulence, pancreatitis, gingival hyperplasia
Rare (less than 0.1%): Gastritis, loose stools

Frequency not reported: Sialadenitis, cramping, gastric irritation, diarrhea, constipation, pancreatitis

Common (1% to 10%): Abdominal pain, diarrhea, dyspepsia, gastroenteritis, nausea
Postmarketing reports: Vomiting, sprue-like enteropathy[Ref]


Common (1% to 10%): Muscle spasms, joint swelling
Uncommon (0.1% to 1%): Back pain, pain in extremity

Common (1% to 10%): Muscle cramps
Uncommon (0.1% to 1%): Arthralgia, back pain, myalgia, rigors, arthrosis
Rare (less than 0.1%): Muscle weakness, twitching

Frequency not reported: Muscle spasm

Common (1% to 10%): Arthritis, back pain, skeletal pain, creatine phosphokinase increased
Uncommon (0.1% to 1%): Myalgia, arthralgia
Postmarketing reports: Rhabdomyolysis[Ref]


Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection
Uncommon (0.1% to 1%): Cough, dyspnea

Common (1% to 10%): Dyspnea
Uncommon (0.1% to 1%): Epistaxis
Rare (less than 0.1%): Coughing, rhinitis

Frequency not reported: Respiratory distress, pneumonitis, pulmonary edema

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


Common (1% to 10%): Fatigue, peripheral edema
Uncommon (0.1% to 1%): Asthenia
Rare (less than 0.1%): Face edema

Very common (10% or more): Edema (up to 10.8%)
Common (1% to 10%): Fatigue, asthenia
Uncommon (0.1% to 1%): Malaise, pain, gynecomastia, chest pain

Frequency not reported: Weakness, fever

Common (1% to 10%): Chest pain, fatigue, influenza-like symptoms, pain, peripheral edema
Postmarketing reports: Asthenia, malaise[Ref]


Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Pollakiuria, erectile dysfunction

Common (1% to 10%): Male sexual dysfunction
Uncommon (0.1% to 1%): Micturition frequency, micturition disorder, nocturia, female sexual dysfunction
Rare (less than 0.1%): Dysuria, polyuria

Frequency not reported: Glycosuria

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


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

Common (1% to 10%): Flushing, palpitation
Uncommon (0.1% to 1%): Hypotension, peripheral ischemia, tachycardia, postural hypotension, hot flushes, vasculitis, arrhythmia, bradycardia
Rare (less than 0.1%): Cardiac failure, pulse irregularity, extrasystoles
Frequency not reported: Arrhythmia, myocardial infarction

Frequency not reported: Cardiac arrhythmias, vasculitis, postural hypotension

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


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

Uncommon (0.1% to 1%): Weight gain, anorexia, thirst, hyperglycemia, weight decrease
Rare (less than 0.1%): Increased appetite

Frequency not reported: Anorexia, loss of appetite, hyperglycemia, hyperuricemia, electrolyte imbalance, hyponatremia, hypokalemia, cholesterol increased, triglycerides increased

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


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

Frequency not reported: Renal failure, renal dysfunction, interstitial nephritis

Postmarketing reports: Acute renal failure, blood creatinine increased[Ref]


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

Common (1% to 10%): Pruritus, rash
Uncommon (0.1% to 1%): Alopecia, pruritus, purpura, rash, sweating increased, angioedema, rash erythematous, rash maculopapular, erythema multiforme
Rare (less than 0.1%): Skin discoloration, urticaria, skin dryness, dermatitis, cold and clammy skin

Frequency not reported: Purpura, photosensitivity, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis, rash, cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus, erythematosus, cutaneous vasculitis, erythema multiforme, exfoliative dermatitis

Uncommon (0.1% to 1%): Rash
Postmarketing reports: Angioedema, alopecia, pruritus, urticaria[Ref]


Uncommon (0.1% to 1%): GGT increased

Postmarketing reports: Hepatic enzymes increased, hepatitis, jaundice

Frequency not reported: Intrahepatic cholestatic jaundice

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


Uncommon (0.1% to 1%): Libido decreased

Uncommon (0.1% to 1%): Depression, insomnia, mood changes, nervousness, abnormal dreams, anxiety, depersonalization
Rare (less than 0.1%): Apathy, agitation

Frequency not reported: Restlessness, sleep disturbances, depression[Ref]


Rare (less than 0.1%): Drug hypersensitivity

Uncommon (0.1% to 1%): Allergic reactions

Frequency not reported: Anaphylactic reactions

Postmarketing reports: Anaphylactic reactions[Ref]


Uncommon (0.1% to 1%): Abnormal vision, conjunctivitis, diplopia, eye pain
Rare (less than 0.1%): Xerophthalmia, abnormal visual accommodation

Frequency not reported: Transient blurred vision, xanthopsia[Ref]


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

Frequency not reported: Aplastic anemia, neutropenia/agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia, bone marrow depression[Ref]


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

2. "Product Information. Tribenzor (amlodipine / hydrochlorothiazide / olmesartan)." Daiichi Pharmaceuticals, Montvale, NJ.

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

Not all side effects for amlodipine / hydrochlorothiazide / 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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.