Spironolactone

Applies to spironolactone: oral suspension, oral tablet

Along with its needed effects, spironolactone 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 spironolactone:

Incidence not known

• Bleeding gums
• bloody or black, tarry stools
• bloody urine
• blurred vision
• breast pain
• chest pain
• clay-colored stools
• clear or bloody discharge from the nipple
• cloudy urine
• confusion
• constipation
• cough
• dark urine
• decrease in urine output or decrease in urine-concentrating ability
• diarrhea
• difficulty with swallowing
• dimpling of the breast skin
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• fast or irregular heartbeat
• fever with or without chills
• general feeling of tiredness or weakness
• headache
• heartburn
• hives, itching, or skin rash
• hoarseness
• increased thirst
• indigestion
• inverted nipple
• loss of appetite
• loss of consciousness
• lower back or side pain
• lump in the breast or under the arm
• muscle pain or cramps
• muscle spasms or twitching
• nausea
• painful or difficult urination
• persistent crusting or scaling of the nipple
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness or swelling of the breast
• seizures
• severe stomach pain
• shakiness and unsteady walk
• sore on the skin of the breast that does not heal
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach cramping, burning, or tenderness
• swelling of the face, fingers, feet, ankles, or lower legs
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tightness in the chest
• trembling
• troubled breathing
• unpleasant breath odor
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• vomiting of blood or material that looks like coffee grounds
• weight gain
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking spironolactone:

Symptoms of overdose

• Irregular heartbeat
• nervousness
• numbness or tingling in the hands, feet, or lips
• rash with flat lesions or small raised lesions on the skin
• reddened skin
• weakness or heaviness of the legs

Some side effects of spironolactone 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:

Incidence not known

• Burning feeling in the chest or stomach
• decreased interest in sexual intercourse
• hair loss or thinning of the hair
• inability to have or keep an erection
• leg cramps
• loss in sexual ability, desire, drive, or performance
• pain in the nipples
• sores, welts, or blisters
• stomach upset
• swelling of the breasts or breast soreness in both females and males
• unusual dullness or feeling of sluggishness

Applies to spironolactone: compounding powder, oral suspension, oral tablet

The most common adverse effect was gynecomastia.

Very common (10% or more): Gynecomastia (13%)

Frequency not reported: Breast disorders in women, slight androgenic effects, breast tenderness in women, voice deepening in women, breast pain

Common (1% to 10%): Hyperkalemia, hyponatremia

Uncommon (0.1% to 1%): Acidosis in patients with liver problems

Rare (less than 0.1%): Dehydration, porphyria, hyperuricemia

Frequency not reported: Reversible hyperchloremic metabolic acidosis in patients with decompensated hepatic cirrhosis, electrolyte disturbances

Common (1% to 10%): Changes in vaginal secretions, amenorrhea, postmenopausal bleeding

Frequency not reported: Reproductive system disorders, erectile dysfunction, impotence, menstrual disorders

Common (1% to 10%): Lethargy in patients with cirrhosis, paresthesia

Rare (less than 0.1%): Paralysis, paraplegia of the limbs due to hyperkalemia

Frequency not reported: Headache, drowsiness, dizziness, ataxia

Common (1% to 10%): Nausea, vomiting

Very rare (less than 0.01%): Gastric inflammation, gastric ulcers, intestinal hemorrhage, cramps

Frequency not reported: Digestive system disorders, diarrhea, indigestion, gastric bleeding

Common (1% to 10%): Libido reduced in women

Uncommon (0.1% to 1%): Confusion

Frequency not reported: Libido reduced in men

Common (1% to 10%): Malaise

Very rare (less than 0.01%): Breast cancer

Common (1% to 10%): Weakness

Frequency not reported: Fatigue, fever

Uncommon (0.1% to 1%): Rash, urticaria, erythema, chloasma, pruritus, exanthema

Rare (less than 0.1%): Eczema

Very rare (less than 0.01%): Alopecia, erythema annulare centrifugum, hypertrichosis

Frequency not reported: Hirsutism, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), maculopapular or erythematous cutaneous eruptions

Uncommon (0.1% to 1%): Muscle spasms, leg cramps

Very rare (less than 0.01%): Systemic lupus erythematosus, osteomalacia

Uncommon (0.1% to 1%): Serum creatinine elevated

Rare (less than 0.1%): BUN increased

Very rare (less than 0.01%): Acute renal failure

Frequency not reported: Renal dysfunction

Rare (less than 0.1%): Thrombocytopenia, eosinophilia, leukopenia

Frequency not reported: Agranulocytosis

Rare (less than 0.1%): Hypersensitivity

Frequency not reported: Anaphylactic reactions

Very rare (less than 0.01%): Vasculitis

Frequency not reported: Mild hypotension

Very rare (less than 0.01%): Hepatitis

Frequency not reported: Mixed cholestatic/hepatocellular toxicity