Aldactone Side Effects Center

Last updated on RxList: 1/6/2023
Aldactone Side Effects Center

What Is Aldactone?

Aldactone (spironolactone) is an aldosterone receptor antagonist that causes the kidneys to remove water and sodium from the body, with reduced losses of potassium. Aldactone is used to reduce edema caused by heart, liver or kidney problems, high blood pressure (hypertension), and certain patients with hyperaldosteronism. Aldactone is available in a generic form named spironolactone.

What Are Side Effects of Aldactone?

Aldactone may cause serious side effects including:

  • lightheadedness,
  • little or no urination,
  • bloody or tarry stools,
  • coughing up blood or vomit that looks like coffee grounds,
  • uneven heart rate,
  • extreme thirst,
  • increased urination,
  • leg discomfort,
  • muscle weakness or limp feeling,
  • vomiting,
  • muscle spasms,
  • numbness or tingly feeling,
  • slow heart rate,
  • weak pulse,
  • headache,
  • confusion,
  • slurred speech,
  • loss of coordination, and
  • feeling unsteady

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Aldactone include:

  • skin rash,
  • headache,
  • dizziness,
  • nausea,
  • vomiting,
  • gas, and
  • stomach pain.

Tell your doctor if you have serious side effects of Aldactone including irregular heart rate, muscle pain or weakness, urinating less than usual, shallow breathing, tremors, confusion, or a severe skin reaction, hyperkalemia (high levels of potassium in the blood), and numbness.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Aldactone

Aldactone is available in 25, 50 and 100 mg tablets.

Aldactone During Pregnancy and Breastfeeding

Because of tumor formation in experimental animals, use in pregnancy should be avoided unless the benefits outweigh the potential risks to the fetus; women who are breastfeeding are advised not to use Aldactone. In addition, the drug should not be used to decrease the normal edema of pregnancy. An active metabolite of Aldactone appears in breast milk. Breastfeeding while using Aldactone is not recommended. If use of Aldactone is deemed essential, an alternative method of infant feeding should be used.

Additional Information

Our Aldactone (spironolactone) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Aldactone Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • little or no urination;
  • high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; o
  • signs of other electrolyte imbalances--increased thirst or urination, confusion, vomiting, muscle pain, slurred speech, severe weakness, numbness, loss of coordination, feeling unsteady.

Common side effects may include:

  • breast swelling or tenderness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Salt and sodium are the same. See Answer
Aldactone Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

The following adverse reactions associated with the use of spironolactone were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure.

Digestive: Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting.

Reproductive: Decreased libido, inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding, breast and nipple pain.

Hematologic: Leukopenia (including agranulocytosis), thrombocytopenia.

Hypersensitivity: Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis.

Metabolism: Hyperkalemia, electrolyte disturbances [see WARNINGS AND PRECAUTIONS], hyponatremia, hypovolemia.

Musculoskeletal: Leg cramps.

Nervous system/psychiatric: Lethargy, mental confusion, ataxia, dizziness, headache, drowsiness.

Liver/biliary: A very few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with spironolactone administration.

Renal: Renal dysfunction (including renal failure).

Skin: Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), alopecia, pruritis.

DRUG INTERACTIONS

Drugs And Supplements Increasing Serum Potassium

Concomitant administration of ALDACTONE with potassium supplementation or drugs that can increase potassium may lead to severe hyperkalemia. In general, discontinue potassium supplementation in heart failure patients who start ALDACTONE [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]. Check serum potassium levels when ACE inhibitor or ARB therapy is altered in patients receiving ALDACTONE.

Examples of drugs that can increase potassium include:

Lithium

Like other diuretics, ALDACTONE reduces the renal clearance of lithium, thus increasing the risk of lithium toxicity. Monitor lithium levels periodically when ALDACTONE is coadministered [see CLINICAL PHARMACOLOGY].

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

In some patients, the administration of an NSAID can reduce the diuretic, natriuretic, and antihypertensive effect of diuretics. Therefore, when ALDACTONE and NSAIDs are used concomitantly, monitor closely to determine if the desired effect of the diuretic is obtained [see CLINICAL PHARMACOLOGY].

Digoxin

Spironolactone and its metabolites interfere with radioimmunoassays for digoxin and increase the apparent exposure to digoxin. It is unknown to what extent, if any, spironolactone may increase actual digoxin exposure. In patients taking concomitant digoxin, use an assay that does not interact with spironolactone.

Cholestyramine

Hyperkalemic metabolic acidosis has been reported in patients given ALDACTONE concurrently with cholestyramine.

Acetylsalicylic Acid

Acetylsalicylic acid may reduce the efficacy of spironolactone. Therefore, when ALDACTONE and acetylsalicylic acid are used concomitantly, ALDACTONE may need to be titrated to higher maintenance dose and the patient should be observed closely to determine if the desired effect is obtained [see CLINICAL PHARMACOLOGY].

Abiraterone

Spironolactone binds to the androgen receptor and may increase prostate-specific antigen (PSA) levels in abiraterone-treated prostate cancer patients. Concomitant use of spironolactone and abiraterone is not recommended.

Read the entire FDA prescribing information for Aldactone (Spironolactone)

© Aldactone Patient Information is supplied by Cerner Multum, Inc. and Aldactone Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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