Applies to amlodipine / hydrochlorothiazide / olmesartan: oral tablet.

Serious side effects

Along with its needed effects, amlodipine/hydrochlorothiazide/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/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

Incidence not known

• Persistent non-healing sore
• pink growth
• reddish patch or irritated area
• shiny bump
• white, yellow or waxy scar-like area

Other side effects

Some side effects of amlodipine / hydrochlorothiazide / 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

• 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

Common (1% to 10%): Renal function impaired

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]