Amlodipine / Hydrochlorothiazide / Olmesartan Side Effects
Medically reviewed by Drugs.com. Last updated on Aug 15, 2024.
Applies to amlodipine / hydrochlorothiazide / olmesartan: oral tablet.
Important warnings
This medicine can cause some serious health issues
Oral route (tablet)
Drugs that act directly on the renin-angiotensin system can cause fetal toxicity, including injury and even death to the developing fetus.
When pregnancy is confirmed, discontinue immediately.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby, especially in your second or third trimester. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away. You may need to stop using this medicine.
This medicine may cause dizziness, lightheadedness, or fainting, especially when you get up suddenly from a lying or sitting position. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.
Check with your doctor right away if you become sick while taking this medicine, especially if you have severe nausea, vomiting, or diarrhea that does not stop. These conditions may cause you to lose too much water and lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.
This medicine may cause angina (chest pain) or a heart attack in certain patients with severe heart or blood vessel disease. Check with your doctor right away if you are having chest pain or discomfort, fast or irregular heartbeat, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, trouble breathing, or sweating.
Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.
Check with your doctor right away if blurred vision, difficulty with reading, eye pain, or any other change in vision occurs during or after treatment. This could be a sign of a serious eye problem. Your doctor may want an eye doctor to check your eyes.
This medicine may affect blood sugar levels. Diabetic patients may notice a change in the results of blood or urine glucose tests. Talk to your doctor if you have any questions.
Severe, chronic diarrhea with weight loss may develop months to years after taking this medicine. Tell your doctor right away if you have these symptoms.
This medicine may increase your risk of getting skin cancer (eg, non-melanoma skin cancer). Avoid sun exposure. Use a sunscreen when you are outdoors. Talk to your doctor if you have concerns about this risk.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.
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 side effects
- 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 side effects
- 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 side effects
- diarrhea
- muscle aches or spasms
- nausea
For healthcare professionals
Applies to amlodipine / hydrochlorothiazide / olmesartan: oral tablet.
General adverse events
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]
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. Cerner Multum, Inc. "Australian Product Information."
3. (2010) "Product Information. Tribenzor (amlodipine / hydrochlorothiazide / olmesartan)." Daiichi Pharmaceuticals
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Further information
Amlodipine/hydrochlorothiazide/olmesartan side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.