Amlodipine, hydrochlorothiazide, and olmesartan

You should not take this medicine if you are allergic to sulfa drugs, or if you are unable to urinate.

Do not use if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away.

If you have diabetes, do not use amlodipine, hydrochlorothiazide, and olmesartan together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo).

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take this medicine with or without food.

Your chest pain may become worse when you first start taking this medicine or when your dose is increased. Call your doctor if your chest pain is severe or ongoing.

Your blood pressure will need to be checked often.

Vomiting, diarrhea, or heavy sweating can cause you to become dehydrated. This can lead to very low blood pressure, electrolyte disorders, or kidney failure while you are taking amlodipine, hydrochlorothiazide, and olmesartan. Drink plenty of water each day while you are taking this medication.

Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual.

If you need surgery or medical tests, tell the surgeon ahead of time that you are using this medicine.

It may take up to 2 weeks before your blood pressure improves. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture and heat.

Do not use potassium supplements or salt substitutes while you are taking this medicine, unless your doctor has told you to.

Drinking alcohol can further lower your blood pressure and may increase side effects of this medicine.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

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]

Some side effects of amlodipine / hydrochlorothiazide / olmesartan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

US BOXED WARNING:
-FETAL TOXICITY: If pregnancy is detected, discontinue this drug as soon as possible. Drugs that act directly on the renin angiotensin system (RAS) can cause injury and death to the developing fetus.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.