Applies to amiloride / hydrochlorothiazide: oral tablet.

Serious side effects

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

More common

• Confusion
• difficulty breathing
• irregular heartbeat
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• stomach pain
• trouble breathing
• weakness or heaviness of the legs

Less common

• Dizziness
• fainting
• fast or slow heartbeat
• labored breathing
• tightness in the chest

Rare

• Ankle, knee, or great toe joint pain
• arm, back, or jaw pain
• blistering, peeling, or loosening of the skin
• bloody or black, tarry stools
• bloody urine
• burning while urinating
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain, discomfort, or heaviness
• chills
• cloudy urine
• cold sweats
• coma
• constipation
• cough
• cracks in the skin
• decreased awareness or responsiveness
• decreased frequency or amount of urine
• diarrhea
• difficult or painful urination
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• dry mouth
• fever
• headache
• increase in heart rate
• increased blood pressure
• increased thirst
• itching
• joint pain, stiffness, or swelling
• lightheadedness
• loss of appetite
• loss of heat from the body
• lower back or side pain
• muscle pain or cramps
• pounding heartbeat or pulse
• rapid breathing
• red skin lesions, often with a purple center
• red, irritated eyes
• red, swollen skin
• scaly skin
• seizures
• severe sleepiness
• severe stomach pain
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sunken eyes
• sweating
• swelling of the face, ankles, hands, fingers, or lower legs
• trouble breathing
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• weight gain
• wrinkled skin

Incidence not known

• Persistent non-healing sore
• pink growth
• reddish patch or irritated area
• shiny bump
• white, yellow or scar-like area

Get emergency help immediately if any of the following symptoms of overdose occur while taking amiloride / hydrochlorothiazide:

Symptoms of overdose

• Drowsiness
• irritability
• mood changes
• pain or weakness in the hands or feet
• trembling
• weak pulse

Other side effects

Some side effects of amiloride / 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:

More common

• Rash
• weight loss

Less common

• Leg ache

Rare

• Bad taste
• bloated, full feeling
• blurred or loss of vision
• changes in appetite
• decreased interest in sexual intercourse
• discouragement
• disturbed color perception
• double vision
• excess air or gas in the stomach or intestines
• feeling of constant movement of self or surroundings
• feeling of warmth
• feeling sad or empty
• general feeling of discomfort or illness
• hair loss or thinning of hair
• hiccups
• inability to have or keep an erection
• increased sweating
• increased urge to urinate during the night
• indigestion
• loss in sexual ability, desire, drive, or performance
• loss of bladder control
• loss of interest or pleasure
• muscle spasm
• night blindness
• overbright appearance of lights
• passing of gas
• redness of the face, neck, arms, and occasionally upper chest
• seeing halos around lights
• sensation of spinning
• sleepiness
• sleeplessness
• stomach fullness or discomfort
• stuffy nose
• swelling of the breasts or breast soreness in both females and males
• trouble concentrating
• trouble sleeping
• tunnel vision
• unable to sleep
• waking to urinate at night

For Healthcare Professionals

Applies to amiloride / hydrochlorothiazide: oral tablet.

General

The most common adverse reactions were headache, weakness, nausea/anorexia, dizziness, and rash.^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea/anorexia, diarrhea, gastrointestinal pain, abdominal pain

Frequency not reported: Constipation, gastrointestinal bleeding, gastrointestinal disturbance, abdominal fullness, vomiting, flatulence

Amiloride:

Frequency not reported: Activation of probable preexisting peptic ulcer, dyspepsia, heartburn, dry mouth

Hydrochlorothiazide:

Frequency not reported: Pancreatitis, sialadenitis, cramping, gastric irritation^[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus

Frequency not reported: Diaphoresis, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, alopecia

Amiloride:

Frequency not reported: Alopecia, itching, diaphoresis

Hydrochlorothiazide:

Frequency not reported: Cutaneous vasculitis, photosensitivity, urticaria, purpura, toxic epidermal necrolysis^[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness

Frequency not reported: Syncope, paresthesia/numbness, vertigo, stupor, sleepiness, bad taste

Amiloride:

Frequency not reported: Encephalopathy, tremors, tinnitus, somnolence^[Ref]

Other

Common (1% to 10%): Weakness, fatigue/tiredness

Frequency not reported: Malaise, chest pain, digitalis toxicity, gynecomastia

Amiloride:

Frequency not reported: Fatigability

Hydrochlorothiazide:

Frequency not reported: Fever^[Ref]

Metabolic

Common (1% to 10%): Serum potassium greater than 5.5 mEq/L

Frequency not reported: Appetite changes, anorexia, thirst, gout, dehydration, symptomatic hyponatremia, electrolyte imbalance, hyponatremia

Hydrochlorothiazide:

Frequency not reported: Electrolyte imbalance, hyperglycemia, hyperuricemia, hypokalemia^[Ref]

Cardiovascular

Common (1% to 10%): Arrhythmia

Frequency not reported: Tachycardia, orthostatic hypotension, angina pectoris, flushing

Amiloride:

Frequency not reported: Palpitation, partial heart block increased to complete heart block

Hydrochlorothiazide:

Frequency not reported: Vasculitis^[Ref]

Musculoskeletal

Common (1% to 10%): Leg ache

Frequency not reported: Back pain, muscle cramps/spasm, joint pain

Amiloride:

Frequency not reported: Painful extremities, neck/shoulder ache^[Ref]

Respiratory

Common (1% to 10%): Dyspnea

Frequency not reported: Hiccups, nasal congestion

Amiloride:

Frequency not reported: Shortness of breath, cough

Hydrochlorothiazide:

Frequency not reported: Respiratory distress, pneumonitis, pulmonary edema^[Ref]

Genitourinary

Frequency not reported: Impotence, nocturia, dysuria, incontinence

Amiloride:

Frequency not reported: Bladder spasm, polyuria, urinary frequency

Hydrochlorothiazide:

Frequency not reported: Glycosuria^[Ref]

Psychiatric

Frequency not reported: Insomnia, nervousness, depression, mental confusion

Amiloride:

Frequency not reported: Libido decreased

Hydrochlorothiazide:

Frequency not reported: Restlessness^[Ref]

Renal

Frequency not reported: Renal dysfunction, renal failure

Hydrochlorothiazide:

Frequency not reported: Interstitial nephritis^[Ref]

Ocular

Frequency not reported: Visual disturbance

Amiloride:

Frequency not reported: Intraocular pressure increased

Hydrochlorothiazide:

Frequency not reported: Transient blurred vision, xanthopsia^[Ref]

Immunologic

Frequency not reported: Anaphylactic reaction

Hydrochlorothiazide:

Frequency not reported: Anaphylactic reaction^[Ref]

Hematologic

Amiloride:

Frequency not reported: Aplastic anemia, neutropenia

Hydrochlorothiazide:

Frequency not reported: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia^[Ref]

Hepatic

Amiloride:

Frequency not reported: Abnormal liver function, jaundice

Hydrochlorothiazide:

Frequency not reported: Intrahepatic cholestatic jaundice^[Ref]