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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.

Severity: Major

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

Severity: Minor

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

General

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

Amlodipine:
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

Hydrochlorothiazide:
Frequency not reported: Lightheadedness, vertigo, paresthesia

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

Gastrointestinal

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

Amlodipine:
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

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

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

Musculoskeletal

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

Amlodipine:
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

Hydrochlorothiazide:
Frequency not reported: Muscle spasm

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

Respiratory

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

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

Hydrochlorothiazide:
Frequency not reported: Respiratory distress, pneumonitis, pulmonary edema

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

Other

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

Amlodipine:
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

Hydrochlorothiazide:
Frequency not reported: Weakness, fever

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

Genitourinary

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

Amlodipine:
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

Hydrochlorothiazide:
Frequency not reported: Glycosuria

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

Cardiovascular

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

Amlodipine:
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

Hydrochlorothiazide:
Frequency not reported: Cardiac arrhythmias, vasculitis, postural hypotension

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

Metabolic

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

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

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

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

Renal

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

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

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

Dermatologic

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

Amlodipine:
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

Hydrochlorothiazide:
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

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

Hepatic

Uncommon (0.1% to 1%): GGT increased

Amlodipine:
Postmarketing reports: Hepatic enzymes increased, hepatitis, jaundice

Hydrochlorothiazide:
Frequency not reported: Intrahepatic cholestatic jaundice

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

Psychiatric

Uncommon (0.1% to 1%): Libido decreased

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

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

Immunologic

Rare (less than 0.1%): Drug hypersensitivity

Amlodipine:
Uncommon (0.1% to 1%): Allergic reactions

Hydrochlorothiazide:
Frequency not reported: Anaphylactic reactions

Olmesartan:
Postmarketing reports: Anaphylactic reactions[Ref]

Ocular

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

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

Hematologic

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

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

References

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. Drugs.com 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.

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