Skip to Content

Avalide Side Effects

Generic Name: hydrochlorothiazide / irbesartan

Note: This page contains information about the side effects of hydrochlorothiazide / irbesartan. Some of the dosage forms included on this document may not apply to the brand name Avalide.

In Summary

More frequent side effects include: dizziness and fatigue. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to hydrochlorothiazide / irbesartan: oral tablet

In addition to its needed effects, some unwanted effects may be caused by hydrochlorothiazide / irbesartan. 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 hydrochlorothiazide / irbesartan:

Less common:
  • Abdominal or stomach pain
  • 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
  • swelling
  • weakness or heaviness of the legs
Rare:
  • Blurred vision
  • convulsions
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • loss of appetite
  • muscle pain or cramps
  • sweating
  • unusual tiredness or weakness
Incidence not known:
  • Dark-colored urine
  • fever
  • hives or welts, itching, or skin rash
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • muscle spasms or stiffness
  • upper right abdominal or stomach pain
  • yellow eyes and skin

Severity: Minor

Some of the side effects that can occur with hydrochlorothiazide / irbesartan 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:

More common:
  • Headache
  • sunburn
Less common:
  • Acid or sour stomach
  • chills
  • congestion
  • cough
  • diarrhea
  • dryness or soreness of the throat
  • joint pain
  • sneezing
  • stomach discomfort or upset
  • tender, swollen glands in the neck
  • trouble sleeping
  • trouble swallowing

For Healthcare Professionals

Applies to hydrochlorothiazide / irbesartan: oral tablet

General

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[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: 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[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

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[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

Irbesartan:
Frequency not reported: Pruritus, dermatitis, ecchymosis, erythema face, urticaria[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

Irbesartan:
Frequency not reported: Jaundice[Ref]

Ocular

Uncommon (0.1% to 1%): Vision disturbance

Hydrochlorothiazide:
Frequency not reported: Transient blurred vision, xanthopsia, acute myopia, secondary acute angle-closure glaucoma

Irbesartan:
Frequency not reported: Vision disturbance, conjunctivitis[Ref]

Hematologic

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

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Avalide (hydrochlorothiazide-irbesartan)." Bristol-Myers Squibb, Princeton, NJ.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Not all side effects for Avalide 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.

Hide