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Aldactone

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Aldactone

Aldactone Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

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, hypertension, and certain patients with hyperaldosteronism. Aldactone is available in a generic form named spironolactone. Common side effects of Aldactone include skin rash, headache, dizziness, and GI symptoms of nausea, vomiting, gas, and stomach pain.

Aldactone is available in 25, 50 and 100 mg tablets. Serious side effects of Aldactone include hyperkalemia, altered heart beats, confusion, tremors, decreased or no urine output, shallow breathing, muscle pain or weakness, and numbness. 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. Aldactone has not been proved safe or effective in the pediatric population.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Aldactone in Detail - Patient Information: Side Effects

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

Stop using spironolactone and call your doctor at once if you have a serious side effect such as:

  • numbness or tingly feeling;
  • muscle pain or weakness;
  • slow, fast, or uneven heart rate;
  • feeling drowsy, restless, or light-headed;
  • urinating less than usual or not at all;
  • shallow breathing;
  • tremors, confusion;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • mild nausea or vomiting;
  • dizziness, headache;
  • gas, stomach pain; or
  • skin rash.

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.

Read the entire detailed patient monograph for Aldactone (Spironolactone) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Aldactone Overview - Patient Information: Side Effects

SIDE EFFECTS: Drowsiness, dizziness, lightheadedness, stomach upset, diarrhea, nausea, vomiting, or headache may occur. To minimize lightheadedness, get up slowly when rising from a seated or lying position. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: increased thirst, change in the amount of urine, mental/mood changes, unusual fatigue/weakness, muscle spasms, menstrual period changes, breast pain, breast enlargement (gynecomastia) in men, sexual function problems.

This medication may lead to high levels of potassium, especially in patients with kidney problems. If not treated, very high potassium levels can be fatal. Tell your doctor immediately if you notice any of the following unlikely but serious side effects: slow/irregular heartbeat, muscle weakness.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (e.g., fever, persistent sore throat), severe stomach/abdominal pain, persistent nausea/vomiting, vomit that looks like coffee grounds, dark urine, yellowing of the eyes/skin, easy bruising/bleeding.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Aldactone (Spironolactone)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Aldactone FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions have been reported and, within each category (body system), are listed in order of decreasing severity.

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

Endocrine: Gynecomastia (see PRECAUTIONS), inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding. Carcinoma of the breast has been reported in patients taking ALDACTONE but a cause and effect relationship has not been established.

Hematologic: Agranulocytosis.

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

Metabolism: Hyperkalemia (see WARNINGS and PRECAUTIONS).

Nervous system /psychiatric: Mental confusion, ataxia, headache, drowsiness, lethargy.

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

Renal: Renal dysfunction (including renal failure).

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

Read the entire FDA prescribing information for Aldactone (Spironolactone) »

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Aldactone - User Reviews

Aldactone User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Aldactone sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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