Aldactone Side Effects
Generic name: spironolactone
Medically reviewed by Drugs.com. Last updated on Oct 11, 2024.
Note: This document provides detailed information about Aldactone.
Applies to spironolactone: oral suspension, oral tablet Side Effects associated with spironolactone. Some dosage forms listed on this page may not apply specifically to the brand name Aldactone.
Applies to spironolactone: oral suspension, oral tablet.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.
Do not take this medicine together with eplerenone (Inspra®). Using these medicines together may cause serious unwanted effects.
Do not take other medicines unless they have been discussed with your doctor. This especially includes potassium supplements or salt substitutes containing potassium, certain diuretics (eg, amiloride, triamterene (Dyazide®, Dyrenium®, Maxzide®, Midamor®, Moduretic®), or other products containing spironolactone (the active ingredient contained in Aldactone) (Aldactazide®).
Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have the following symptoms: stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, or weakness or heaviness of the legs. Ask your doctor before you use any medicine, supplement, or salt substitute that contains potassium.
Spironolactone may worsen kidney function in patients with low to no salt in their body or in those who take other blood pressure medicines (eg, ARB, ACE inhibitor). Talk to your doctor if you have concerns about this.
Dizziness, lightheadedness, or fainting may also occur, especially when you get up suddenly from a lying or sitting position. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.
This medicine may also cause electrolyte imbalances (including low sodium, magnesium, and calcium in the blood, hypochloremic alkalosis) and an increase in your uric acid and blood sugar levels. Talk to your doctor if you have concerns.
Check with your doctor right away if you become sick while taking this medicine, especially if you have severe or continuing nausea, vomiting, or diarrhea that does not stop. These conditions may cause you to lose too much water or salt and may lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.
This medicine may cause swelling of the breasts (gynecomastia) and breast pain in some patients. If you have questions about this, talk to your doctor.
Make sure any doctor or dentist who treats you knows that you are using this medicine.
Serious side effects of Aldactone
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
Other side effects of Aldactone
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
For healthcare professionals
Applies to spironolactone: compounding powder, oral suspension, oral tablet.
General adverse events
The most common adverse effect was gynecomastia.[Ref]
Endocrine
- 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[Ref]
Metabolic
- 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[Ref]
Genitourinary
- Common (1% to 10%): Changes in vaginal secretions, amenorrhea, postmenopausal bleeding
- Frequency not reported: Reproductive system disorders, erectile dysfunction, impotence, menstrual disorders[Ref]
Nervous system
- 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[Ref]
Gastrointestinal
- 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[Ref]
Psychiatric
- Common (1% to 10%): Libido reduced in women
- Uncommon (0.1% to 1%): Confusion
- Frequency not reported: Libido reduced in men[Ref]
Oncologic
- Common (1% to 10%): Malaise
- Very rare (less than 0.01%): Breast cancer[Ref]
Other
- Common (1% to 10%): Weakness
- Frequency not reported: Fatigue, fever[Ref]
Dermatologic
- 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[Ref]
Musculoskeletal
- Uncommon (0.1% to 1%): Muscle spasms, leg cramps
- Very rare (less than 0.01%): Systemic lupus erythematosus, osteomalacia[Ref]
Renal
- 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[Ref]
Hematologic
- Rare (less than 0.1%): Thrombocytopenia, eosinophilia, leukopenia
- Frequency not reported: Agranulocytosis[Ref]
Immunologic
- Rare (less than 0.1%): Hypersensitivity
- Frequency not reported: Anaphylactic reactions[Ref]
Cardiovascular
- Very rare (less than 0.01%): Vasculitis
- Frequency not reported: Mild hypotension[Ref]
Hepatic
- Very rare (less than 0.01%): Hepatitis
- Frequency not reported: Mixed cholestatic/hepatocellular toxicity[Ref]
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References
1. (2001) "Product Information. Aldactone (spironolactone)." Searle
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Cerner Multum, Inc. "Australian Product Information."
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Further information
Aldactone side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.