Summary

More frequently reported side effects include: dizziness and fatigue. Continue reading for a comprehensive list of adverse effects.

Applies to hydrochlorothiazide / irbesartan: oral tablet.

Serious side effects

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

• 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

• 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

Other side effects

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

• Headache
• sunburn

Less common

• 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

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

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]