Avalide Side Effects
Generic name: hydrochlorothiazide / irbesartan
Medically reviewed by Drugs.com. Last updated on Sep 2, 2024.
Note: This document provides detailed information about Avalide Side Effects associated with hydrochlorothiazide / irbesartan. Some dosage forms listed on this page may not apply specifically to the brand name Avalide.
Applies to hydrochlorothiazide / irbesartan: oral tablet.
Important warnings
This medicine can cause some serious health issues
Oral route (tablet)
May cause injury or death to a developing fetus.
Discontinue use as soon as possible if pregnancy is detected.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that 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. If you faint, call your doctor right away.
Check with your doctor right away if you become sick while taking this medicine, especially if you have severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water and lead to low blood pressure. You can also loose water by sweating, so drink plenty of water during exercise or in hot weather.
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 immediately if blurred vision, difficulty with reading, eye pain, or any other change in vision occurs during or after treatment. These could be signs of serious eye problems (eg, angle-closure glaucoma, myopia, and choroidal effusion). Your doctor will want you to have your eyes checked by an ophthalmologist (eye doctor).
This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.
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. Avoid sunlamps and tanning beds. Talk to your doctor if you have concerns about this risk.
Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have stomach pain, confusion, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, trouble breathing, or weakness or heaviness of the legs. Ask your doctor before you use medicines, supplements, or salt substitutes that contain potassium.
Alcohol, narcotic pain relievers, or sleeping pills may cause you to feel more lightheaded, dizzy, or faint when used with this medicine. Tell your doctor if you are drinking alcohol or using pain relievers or sleeping pills.
Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.
Common side effects of Avalide
Some side effects of hydrochlorothiazide / irbesartan 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:
More common side effects
- headache
- sunburn
Less common side effects
- acid or sour stomach
- blistering, peeling, loosening of the skin
- chills
- congestion
- cough
- diarrhea
- dryness or soreness of the throat
- joint pain
- red irritated eyes
- red skin lesions, often with a purple center
- sneezing
- sores, ulcers, or white spots in the mouth or on the lips
- stomach discomfort or upset
- tender, swollen glands in the neck
- trouble sleeping
- trouble swallowing
Serious side effects of Avalide
Along with its needed effects, hydrochlorothiazide/irbesartan 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 hydrochlorothiazide / irbesartan:
Less common side effects
- bloody or cloudy urine
- chest pain
- confusion
- difficult with breathing
- difficult, burning, or painful urination
- fast, pounding, or irregular heartbeat or pulse
- frequent urge to urinate
- lower back or side pain
- nausea or vomiting
- numbness or tingling in the hands, feet, or lips
- stomach pain
- swelling
- weakness or heaviness of the legs
Rare side effects
- blurred vision
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- loss of appetite
- muscle pain or cramps
- seizures
- sweating
- unusual tiredness or weakness
Incidence not known
- dark-colored urine
- eye pain
- fever
- hives or welts, itching, skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- muscle spasms or stiffness
- nearsightedness
- persistent non-healing sore
- pink growth
- reddish patch or irritated area
- shiny bump
- upper right abdominal or stomach pain
- white, yellow or waxy scar-like area
- yellow eyes and skin
For healthcare professionals
Applies to hydrochlorothiazide / irbesartan: oral tablet.
General adverse events
The most common adverse reactions were headache, dizziness, fatigue, and musculoskeletal pain.[Ref]
Nervous system
- Very common (10% or more): Headache (up to 11%)
- Common (1% to 10%): Dizziness, dizziness orthostatic
- Uncommon (0.1% to 1%): Syncope, abnormal reflexes, coordination disturbance, numbness, paresthesia, somnolence, vertigo, taste disturbance
- Frequency not reported: Tinnitus, dysgeusia
Hydrochlorothiazide:
- Very common (10% or more): Headache (up to 11.6%)
- Common (1% to 10%): Dizziness, dizziness orthostatic
- Frequency not reported: Vertigo, paresthesia, lightheadedness
Irbesartan:
- Common (1% to 10%): Dizziness, dizziness orthostatic, headache
- Frequency not reported: Syncope, anxiety/nervousness, numbness, somnolence, vertigo, paresthesia, tremor, transient ischemic attack, cerebrovascular accident
- Postmarketing reports: Tinnitus[Ref]
Other
- Common (1% to 10%): Chest pain, fatigue, edema
- Uncommon (0.1% to 1%): Cold sensation, malaise, weakness, extremity swelling, abnormal hearing
Hydrochlorothiazide:
- Common (1% to 10%): Chest pain, fatigue, edema
- Frequency not reported: Weakness, fever
Irbesartan:
- Common (1% to 10%): Chest pain, fatigue, edema
- Frequency not reported: Tinnitus
- Frequency not reported: Fever, chills, orthostatic effects, facial edema, upper extremity edema, extremity swelling, hearing abnormality, ear pain[Ref]
Musculoskeletal
- Common (1% to 10%): Musculoskeletal pain, muscle cramp, musculoskeletal trauma, creatine kinase increased
- Uncommon (0.1% to 1%): Muscle ache, myalgia, extremity weakness
- Frequency not reported: Arthralgia
Hydrochlorothiazide:
- Very common (10% or more): Musculoskeletal pain (10%)
- Common (1% to 10%): Muscle cramp, musculoskeletal trauma
- Frequency not reported: Muscle spasm
Irbesartan:
- Common (1% to 10%): Musculoskeletal pain, musculoskeletal trauma
- Uncommon (0.1% to 1%): Muscle cramp
- Frequency not reported: Arthritis, muscle ache, musculoskeletal chest pain, joint stiffness, bursitis, muscle weakness
- Postmarketing reports: Creatine phosphokinase increased, rhabdomyolysis[Ref]
Respiratory
- Common (1% to 10%): Sinus abnormality, cough, upper respiratory infection, pharyngitis, rhinitis, dry nasopharynx, dyspnea, wheezing
Hydrochlorothiazide:
- Common (1% to 10%): Cough, pharyngitis, rhinitis, sinus abnormality, upper respiratory infection
- Frequency not reported: Respiratory distress, pneumonitis, pulmonary edema
Irbesartan:
- Common (1% to 10%): Cough, pharyngitis, rhinitis, sinus abnormality, upper respiratory infection
- Frequency not reported: Epistaxis, tracheobronchitis, congestion, pulmonary congestion, dyspnea, wheezing[Ref]
Gastrointestinal
- Common (1% to 10%): Abdominal pain, nausea/vomiting, dyspepsia/heartburn, diarrhea, anorectal disorder
- Uncommon (0.1% to 1%): Constipation, abdominal distention, dry mouth, epigastric pain, flatulence, gastroesophageal reflux
Hydrochlorothiazide:
- Common (1% to 10%): Abdominal pain, nausea/vomiting, dyspepsia/heartburn, diarrhea
- Frequency not reported: Pancreatitis, sialadenitis, cramping, gastric irritation, constipation
Irbesartan:
- Common (1% to 10%): Abdominal pain, nausea/vomiting, diarrhea
- Uncommon (0.1% to 1%): Anorectal disorder, dyspepsia/heartburn
- Frequency not reported: Constipation, gastroenteritis, flatulence, abdominal distention[Ref]
Genitourinary
- Common (1% to 10%): Abnormality urination, urinary tract infection, sexual dysfunction
Hydrochlorothiazide:
- Common (1% to 10%): Abnormality urination, urinary tract infection
- Frequency not reported: Glycosuria
Irbesartan:
- Common (1% to 10%): Abnormality urination, urinary tract infection
- Frequency not reported: Sexual dysfunction, prostate disorder[Ref]
Metabolic
- Common (1% to 10%): Hypokalemia, hyperkalemia
- Uncommon (0.1% to 1%): Diabetes, gout, weight gain, serum potassium decreased, serum sodium decreased
Hydrochlorothiazide:
- Frequency not reported: Hyperglycemia, hyperuricemia, hypokalemia, hyponatremia, anorexia, loss of appetite, cholesterol increased, triglycerides increased
Irbesartan:
- Frequency not reported: Gout
- Postmarketing reports: Hyperkalemia, hypoglycemia in diabetic patients[Ref]
Renal
- Common (1% to 10%): BUN increased, serum creatinine increased
- Frequency not reported: Impaired renal function, renal failure
Hydrochlorothiazide:
- Frequency not reported: Renal failure, renal dysfunction, interstitial nephritis
- Postmarketing reports: Renal function impaired
Irbesartan:
- Postmarketing reports: Impaired renal function, renal failure[Ref]
Immunologic
- Common (1% to 10%): Influenza, allergy
Hydrochlorothiazide:
- Common (1% to 10%): Influenza, allergy
- Frequency not reported: Anaphylactic reactions
Irbesartan:
- Common (1% to 10%): Influenza, allergy
- Frequency not reported: Ear infection
- Postmarketing reports: Anaphylactic reaction, anaphylactic shock[Ref]
Cardiovascular
- Common (1% to 10%): Tachycardia
- Uncommon (0.1% to 1%): Hypotension, bradycardia, disturbance of cardiac rhythm, subjective disturbance of cardiac rhythm, disturbance of ventricular rhythm, ECG abnormality, flushing, orthostatic hypotension, hot flushes
Hydrochlorothiazide:
- Common (1% to 10%): Tachycardia
- Frequency not reported: Vasculitis, cardiac arrhythmias, postural hypotension
Irbesartan:
- Common (1% to 10%): Tachycardia
- Frequency not reported: Flushing, hypertension, cardiac murmur, myocardial infarction, angina pectoris, hypotension, arrhythmic/conduction disorder, cardiorespiratory arrest, heart failure, hypertensive crisis[Ref]
Psychiatric
- Common (1% to 10%): Anxiety/nervousness
- Uncommon (0.1% to 1%): Libido changes, depression, emotional lability/disturbance, sleep disturbance
Hydrochlorothiazide:
- Uncommon (0.1% to 1%): Anxiety/nervousness
- Frequency not reported: Restlessness
Irbesartan:
- Common (1% to 10%): Anxiety/nervousness
- Frequency not reported: Libido change, sleep disturbance, emotional disturbance, depression[Ref]
Dermatologic
- Common (1% to 10%): Rash
- Uncommon (0.1% to 1%): Pruritus, skin discomfort, hyperhidrosis
- Frequency not reported: Angioedema, urticaria
Hydrochlorothiazide:
- Common (1% to 10%): Rash
- Frequency not reported: Purpura, photosensitivity, urticaria, cutaneous vasculitis, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, cutaneous lupus erythematosus-like reactions
- Postmarketing reports: Non-melanoma skin cancer
Irbesartan:
- Frequency not reported: Pruritus, dermatitis, ecchymosis, erythema face, urticaria
- Postmarketing reports: Angioedema[Ref]
Hepatic
- Uncommon (0.1% to 1%): Jaundice
- Frequency not reported: Liver enzymes increased, serum bilirubin increased, hepatitis, abnormal liver function
Hydrochlorothiazide:
- Frequency not reported: Intrahepatic cholestatic jaundice
- Postmarketing reports: Jaundice, hepatitis
Irbesartan:
- Frequency not reported: Jaundice
- Postmarketing reports: Hepatitis[Ref]
Ocular
- Uncommon (0.1% to 1%): Vision disturbance
Hydrochlorothiazide:
- Frequency not reported: Transient blurred vision, xanthopsia, acute myopia, secondary acute angle-closure glaucoma, choroidal effusion
Irbesartan:
- Frequency not reported: Vision disturbance, conjunctivitis[Ref]
Hematologic
Hydrochlorothiazide:
- Frequency not reported: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia, bone marrow depression
Irbesartan:
- Postmarketing reports: Thrombocytopenia, anemia[Ref]
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. Cerner Multum, Inc. "Australian Product Information."
3. (2015) "Product Information. Avalide (hydrochlorothiazide-irbesartan)." Bristol-Myers Squibb
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Further information
Avalide 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.