Applies to candesartan / hydrochlorothiazide: oral tablet.

Serious side effects

Along with its needed effects, candesartan / hydrochlorothiazide 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 candesartan / hydrochlorothiazide:

Less common

• Cough
• dizziness
• dryness of the mouth
• fever
• increased thirst
• irregular heartbeat
• lightheadedness
• muscle cramps
• nausea
• sore throat
• unusual tiredness
• vomiting
• weak pulse
• weakness

Rare

• Arm pain
• chest pain or tightness
• fast heartbeat
• large, hive like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• trouble breathing

Incidence not known

• Black, tarry stools
• chills
• confusion
• lower back or side pain
• nervousness
• numbness or tingling in the hands, feet, or lips
• painful or difficult urination
• pale skin
• persistent non-healing sore
• pink growth
• reddish patch or irritated area
• shiny bump
• sores, ulcers, or white spots in the mouth or on the lips
• stomach pain
• swelling of the face, ankles, or hands
• unusual bleeding or bruising
• weakness or heaviness of the legs
• white, yellow or waxy scar-like area

Other side effects

Some side effects of candesartan / hydrochlorothiazide 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

• Back pain
• diarrhea
• headache
• joint pain
• loss of appetite
• muscle aches and pains
• runny nose
• sneezing
• sweating
• trouble sleeping

Incidence not known

• Blistering, peeling, loosening of skin
• decreased interest in sexual intercourse
• hair loss, thinning of the hair
• hives or welts, itching, skin rash
• inability to have or keep an erection
• increased sensitivity of the skin to sunlight
• loss in sexual ability, desire, drive, or performance
• redness of the skin
• redness or other discoloration of the skin
• red irritated eyes
• red skin lesions, often with a purple center
• severe sunburn

For Healthcare Professionals

Applies to candesartan / hydrochlorothiazide: oral tablet.

Respiratory

Common (1% to 10%): Upper respiratory tract infection, respiratory infection, bronchitis, pharyngitis, sinusitis, nasopharyngitis, cough

Candesartan:

Frequency not reported: Cough, rhinitis

Hydrochlorothiazide:

Frequency not reported: Pneumonitis, pulmonary edema^[Ref]

Metabolic

Common (1% to 10%): Hypokalemia, dyslipidemia

Uncommon (0.1% to 1%): Hyperkalemia

Candesartan:

Very rare (less than 0.01%): Hyponatremia, hyperkalemia

Hydrochlorothiazide:

Frequency not reported: Anorexia, loss of appetite, hyperglycemia, hyperuricemia, hyponatremia, hypokalemia, cholesterol increased, triglycerides increased^[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, nausea

Uncommon (0.1% to 1%): Vomiting

Candesartan:

Frequency not reported: Diarrhea

Hydrochlorothiazide:

Frequency not reported: Gastric irritation, diarrhea, constipation

Postmarketing reports: Sialadenitis, cramping^[Ref]

Other

Common (1% to 10%): Influenza-like symptoms, inflicted injury

Frequency not reported: Fatigue

Candesartan:

Frequency not reported: Peripheral edema

Hydrochlorothiazide:

Frequency not reported: Fever, weakness, vertigo^[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache

Candesartan:

Postmarketing reports: Somnolence

Hydrochlorothiazide:

Frequency not reported: Lightheadedness, paresthesia^[Ref]

Cardiovascular

Common (1% to 10%): Tachycardia

Uncommon (0.1% to 1%): Atrioventricular block

Candesartan:

Postmarketing reports: Palpitations

Hydrochlorothiazide:

Frequency not reported: Vasculitis, postural hypotension, cardiac arrhythmias^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain

Postmarketing reports: Myalgia

Candesartan:

Postmarketing reports: Rhabdomyolysis

Hydrochlorothiazide:

Frequency not reported: Muscle spasm^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection

Hydrochlorothiazide:

Frequency not reported: Glycosuria

Postmarketing reports: Impotence^[Ref]

Dermatologic

Candesartan:

Very rare (less than 0.01%): Angioedema, urticaria, pruritus, rash

Hydrochlorothiazide:

Frequency not reported: Photosensitivity reactions, rash, cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, urticaria, cutaneous vasculitis, toxic epidermal necrolysis

Postmarketing reports: Purpura, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, alopecia^[Ref]

Hematologic

Candesartan:

Very rare (less than 0.01%): Leucopenia, neutropenia, agranulocytosis

Hydrochlorothiazide:

Frequency not reported: Leucopenia, neutropenia, agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia, bone marrow depression^[Ref]

Hepatic

Candesartan:

Very rare (less than 0.01%): Liver enzymes increased, abnormal hepatic function, hepatitis

Hydrochlorothiazide:

Frequency not reported: Intrahepatic cholestatic jaundice, pancreatitis^[Ref]

Renal

Candesartan:

Very rare (less than 0.01%): Renal impairment, renal failure

Hydrochlorothiazide:

Frequency not reported: BUN increased, serum creatinine increased, renal dysfunction, interstitial nephritis^[Ref]

Psychiatric

Candesartan:

Postmarketing reports: Agitation, anxiety, depression, insomnia, nervousness, sleep disorder, nightmare

Hydrochlorothiazide:

Frequency not reported: Restlessness, sleep disturbances, depression^[Ref]

Ocular

Hydrochlorothiazide:

Frequency not reported: Transient blurred vision, acute myopia, acute angle-closure glaucoma, xanthopsia^[Ref]

Immunologic

Hydrochlorothiazide:

Frequency not reported: Anaphylactic reactions^[Ref]