Side effects of spironolactone

Spironolactone

Spironolactone is the generic form of the brand-name drug Aldactone, a prescription diuretic drug.

The drug is used to treat a condition called primary hyperaldosteronism, in which the body produces excess amounts of the hormone aldosterone, which regulates your body’s sodium and water levels.

Spironolactone helps restore a healthy balance of sodium and potassium in your body.

It’s also used to treat:

  • Essential hypertension (high blood pressure with an unknown cause)
  • Hypokalemia (potassium deficiency)
  • Edema (fluid retention) from various conditions, including congestive heart failure, kidney disease, and cirrhosis (liver scarring)
  • Severe heart failure

Spironolactone is a potassium-sparing diuretic. Sometimes called “water pills,” diuretics help the kidneys expel water and salt in urine while retaining potassium.

The drug may also be used in combination with other medications to treat precocious (early) puberty and myasthenia gravis, a neuromuscular disease.

Manufactured by Pfizer, spironolactone was approved by the Food and Drug Administration (FDA) in 1985.

Though spironolactone has been around for over 25 years, the FDA is still updating the drug’s safety labeling.

In 2011, the FDA added Stevens-Johnson syndrome and toxic epidermal necrolysis — two life-threatening skin disorders — to spironolactone’s list of possible side effects.

In 2013, the agency added a warning about a potentially fatal condition called hyperkalemia (high potassium levels in the blood).

Spironolactone for Acne

Spironolactone is sometimes used off-label to treat women with persistent adult acne due to increased androgen levels, because the drug is able to inhibit the activity of sebaceous glands (small skin glands that releases an oily, lubricating substance called sebum).

The development of acne lesions is associated partly with increased sebum secretion, which can be stimulated in women by androgen excess.

Spironolactone for Hair Loss and Hirsutism

Because of its anti-androgen activity, spironolactone is also used off-label to treat female-pattern hair loss and hirsutism.

Women with certain endocrine disorders produce more androgens than normal, leading to hair loss on the top or front of the scalp, and increased hair on the face and other (generally hair-free) body areas.

Spironolactone helps by slowing down the production, and blocking the action, of androgens.

Spironolactone Warnings

Spironolactone carries a black-box warning for tumor risk, due to chronic toxicity studies that show spironolactone can cause tumor development in rats.

Spironolactone shouldn’t be taken with potassium-supplementing drugs or diets because the excessive potassium intake may cause hyperkalemia, which can lead to abnormal heart rhythms (arrhythmias).

Your doctor should also know if you have severe heart failure, because hyperkalemia has an increased risk of death in such cases.

Additionally, tell your doctor if you have liver problems such as cirrhosis, as even minor changes in fluid and electrolyte balance may cause liver-related coma.

Spironolactone shouldn’t be used if you have certain kidney problems or conditions associated with hyperkalemia, including the adrenal gland disorder known as Addison’s disease.

Pregnancy and Spironolactone

Spironolactone may pose risks to a developing fetus.

Some research suggests that spironolactone has the potential to feminize male fetuses during early pregnancy and cause endocrine problems in late pregnancy by inhibiting the activity of male hormones (androgens).

In general, diuretics such as spironolactone aren’t recommended for pregnant women.

Unless the drug is absolutely necessary, it’s not recommended for women who are breastfeeding because canrenone, a byproduct of spironolactone, is excreted in breast milk.

Aldactone

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 12/05/2018

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. 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.

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

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.

For a really cheap and safe medication, spironolactone has many uses. From heart health to hair growth, this popular diuretic is safe and effective.

How does spironolactone work for so many conditions?

Spironolactone is commonly known as a potassium-sparing diuretic, which means in exchange for relieving the body of sodium and water, it makes the body retain potassium. This is how spironolactone works to protect the heart, lower blood pressure, and help with any leg swelling that a weak heart can cause.

Wait, but what else?

When it comes to excess hair growth, acne, and female pattern hair loss, spironolactone also works because it blocks the production and action of hormones like testosterone.

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Below, we’ll talk about seven conditions for which spironolactone at different doses can help.

1) Acute heart failure

When added to standard therapy, spironolactone at a starting dose of 12.5 – 25 mg once daily has been shown to help patients with acute heart failure, increasing the likelihood of survival and reducing the risk of hospitalization. It is also recommended in patients after a heart attack who develop heart failure symptoms like difficulty breathing, or have a history of diabetes.

2) High blood pressure

Spironolactone is not recommended as first-line treatment for high blood pressure, but when added to another blood pressure medication, 25 mg of spironolactone may help.

3) Swelling in the legs

For lower extremity swelling (known as edema), 25 – 200 mg of spironolactone taken daily may help to relieve the body of some of that fluid.

4) Acne in women

Several studies have shown that spironolactone taken at a dose of 50 – 200 mg once daily improves acne in women.

5) Excess hair growth in women

Oral contraceptives are the initial choice for the treatment of hirsutism, characterized by excess hair growth on the face or body in young women. However, studies have shown that spironolactone added to oral contraceptives delivers better results. When used for hirsutism, 50 – 200 mg daily in one to two divided doses is better than placebo and better than oral contraceptives alone.

6) Female pattern hair loss

Female pattern hair loss is characterized by thinning on the crown. In a 2005 British Journal of Dermatology study, 44% of women treated with 200 mg of spironolactone daily had regrowth of hair, while another 44% had no change.

7) Abdominal fluid buildup due to liver disease

Spironolactone is well studied in patients with liver disease or cirrhosis. When fluid accumulates in the abdomen due to liver disease (a condition known as ascites), 100 mg of spironolactone once daily, slowly dosed up to a maximum daily dose of 400 mg, may help.

– – –

Spironolactone is not for everyone. Women of reproductive age need to be aware that it should not be used during the first trimester of pregnancy. That’s because the anti-male hormone effects of spironolactone have been shown to cause feminization of the male fetus in animal studies.

Dr O.

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  • About spironolactone

    Type of medicine Aldosterone antagonist diuretic, potassium-sparing diuretic
    Used for Fluid retention
    Heart failure
    Primary hyperaldosteronism
    Also called Aldactone®, Lasilactone® (spironolactone with furosemide); Aldactide® (spironolactone with hydroflumethiazide)
    Available as Tablets

    Spironolactone is used to treat fluid retention (oedema) caused by liver disease, kidney problems or heart failure. Oedema occurs when fluid leaks out of your blood vessels, causing swelling in the tissues of your lungs, feet or ankles. This makes you feel breathless or your legs feel puffy. Spironolactone prevents a build-up of fluid in your body by increasing the amount of urine your kidneys produce. It is also used to treat some other conditions which cause fluid retention, such as a disorder called primary hyperaldosteronism.

    Spironolactone is known as a potassium-sparing diuretic. Unlike some other diuretics, it does not cause your body to lose potassium. Diuretics are sometimes referred to as ‘water tablets’.

    Spironolactone is often used alongside other diuretics. When it is used like this, it may be prescribed as a combination product, such as in Lasilactone® (spironolactone with furosemide) and Aldactide® (spironolactone with hydroflumethiazide). Combinations like these help to reduce the number of tablets you need to take each day.

    Before taking spironolactone

    Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking spironolactone it is important that your doctor or pharmacist knows:

    • If you are pregnant, trying for a baby or breastfeeding.
    • If you have kidney problems.
    • If you have a problem with your adrenal glands, called Addison’s disease.
    • If you have a rare inherited blood disorder, called porphyria.
    • If you are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.
    • If you have ever had an allergic reaction to a medicine.

    How to take spironolactone

    • Before you start this treatment, read the manufacturer’s printed information leaflet from inside your pack. The leaflet will give you more information about spironolactone and a full list of side-effects which you may experience from taking it.
    • Take spironolactone exactly as your doctor has told you. The usual dose varies from 25 mg to 200 mg. Depending upon which dose is right for you, you may be asked to take several tablets a day but these are generally taken at the same time.
    • Take the tablets with or just after a meal.
    • Spironolactone is commonly prescribed just once daily and you can generally take the dose at a time to suit you. However, diuretics are best taken no later than mid-afternoon. This is because you will find you may need to go to the toilet a couple of times after taking them and this could disturb your sleep if you take it late in the day.
    • If you have been prescribed more than one tablet of spironolactone a day and told to take them at different times, make sure you take your last tablet no later than 6 pm.
    • If you forget to take a dose, take it as soon as you remember. However, if it is after 6 pm in the evening, skip the missed dose and continue as usual the next day. Do not take two doses at the same time to make up for a missed dose.

    Getting the most from your treatment

    • Try to keep your regular appointments with your doctor. This is so your doctor can check on your progress. The salt balance in your bloodstream may be upset by diuretics and your doctor will want you to have a blood test from time to time to check for this.
    • Diuretics help you to lose water, so you can breathe or move more easily. If, however, you lose too much fluid, you may become dehydrated. This will make you feel thirsty and make your skin look and feel dry. Let your doctor know if this happens, as your dose may need to be adjusted.
    • Another sign of dehydration with spironolactone is rapid weight loss after starting the tablets. Speak with your doctor if you notice this happening.
    • Because spironolactone is a potassium-conserving diuretic, you should try to avoid things with a high potassium content, such as ‘salt substitutes’ or low-sodium salt. This is so the level of potassium in your body does not become too high.
    • Treatment with diuretics is usually long-term, so continue to take these tablets unless you are advised otherwise by your doctor.
    • If you buy any medicines, check with a pharmacist that they are suitable to take with your other medicines.
    • If you are having an operation or dental treatment, tell the person carrying out the treatment which medicines you are taking.

    Can spironolactone cause problems?

    Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. These usually improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following side-effects continue or become troublesome.

    Spironolactone side-effects What can I do if I experience this?
    Feeling sick (nausea) or being sick (vomiting) Stick to simple meals – avoid rich or spicy foods
    Feeling tired, dizzy, or sleepy If this happens, do not drive and do not use tools or machines until you feel better
    Sexual problems, breast discomfort and enlargement, feeling confused, irregular periods, confusion, sweating, cramps, hair loss or unwanted hair growth, and skin rash If any of these become troublesome, speak with your doctor

    If you experience any other symptoms which you think may be due to this medicine, speak with your doctor or pharmacist.

    How to store spironolactone

    • Keep all medicines out of the reach and sight of children.
    • Store in a cool, dry place, away from direct heat and light.

    Important information about all medicines

    Never take more than the prescribed dose. If you suspect that you or someone else has taken an overdose of this medicine, go to the accident and emergency department of your local hospital at once. Take the container with you, even if it is empty.

    This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.

    Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.

    If you have any questions about this medicine ask your pharmacist.

    A pharmaceutical company has issued a voluntary nationwide recall of a popular blood pressure medication, hydrochlorothiazide, after a lot of the company’s product was found to be mislabeled, the Food and Drug Administration said this week.

    The labels of the Accord Healthcare bottles say they contain 100 12.5-milligram tablets of hydrochlorothiazide, but they actually contain 100 25-milligram tablets of spironolactone, a drug used to treat heart, liver and kidney failure, the FDA said in a statement issued Monday.

    Accord Healthcare’s hydrochlorothiazide tablets.Accord Healthcare

    Accord does not believe that other lots of hydrochlorothiazide are involved in the mix-up, the FDA said, adding that Accord learned of the error after a pharmacy alerted the company. The recall does not affect hydrochlorothiazide sold by other drug companies.

    Let our news meet your inbox. The news and stories that matters, delivered weekday mornings.

    Spironolactone is commonly used to treat fluid retention, or edema, in patients with heart, liver and kidney failure. The drug is also frequently used to help control high blood pressure and increase potassium in the blood. Common side effects are mild nausea, vomiting, diarrhea, dizziness, leg cramps, headache, and difficulty having an erection.

    The FDA said spironolactone could increase potassium levels in some patients, potentially leading to life-threatening situations. Taken in large doses, spironolactone, sold under the brand names Aldactone and CaroSpir, can cause arrhythmia. Patients who experience racing heart or chest pain are encouraged to see their doctors immediately.

    No injuries have been reported, the FDA said.

    Hydrochlorothiazide 12.5-milligram tablets are light orange to peach-colored, round and printed with an H on one side and a 1 on the other.

    Patients whose pills do not match that description should return them to the pharmacy or doctor who issued them, the FDA said.

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    Caution is key when prescribing spironolactone for adult acne

    NEWPORT BEACH, CALIF. – While off-label use of spironolactone for treatment of acne is quite common, it should be prescribed with special caution, advised Julie C. Harper, MD.

    “The vast majority of you write this for acne,” Dr. Harper, a dermatologist in private practice in Birmingham, Ala., said during a presentation on adult acne at the Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.

    Dr. Julie C. Harper

    She offered this blunt advice about one potential patient group: “Do not use this in men.” She cited a 2006 Japanese study of 139 patients with acne, treated with oral spironolactone, which found that 3 of the 23 males in the study developed gynecomastia within 4-6 weeks. Subsequently, the treatment was stopped in all male patients (Aesthetic Plast Surg. 2006 Nov-Dec;30:689-94).

    In the same study, 80% of the 116 females in the study experienced menstrual irregularities. “We have to tell our patients that’s a possible side effect, that they may get breast tenderness or menstrual irregularities,” Dr. Harper said. “If you don’t tell them, they’re not thinking of acne drugs as causing this.”

    What about the risk of hyperkalemia in patients who take spironolactone, which is a diuretic? A retrospective study found similar hyperkalemia rates among healthy young women taking spironolactone for acne or an endocrine disorder with associated acne (mean age 26-27 years) and among healthy young women not taking spironolactone. The authors concluded that routine potassium testing was not necessary in healthy young women who take the drug (JAMA Dermatol. 2015 Sep;151:941-4).

    Dr. Harper recommended testing, however, if patients are older, have a history of renal or cardiac disease, have impaired hepatic function, or are taking higher doses of spironolactone.

    She also cautioned that spironolactone should not be taken with lithium, and that it boosts the risk of digoxin toxicity.

    Research doesn’t indicate that the risk of breast cancer is increased in women taking spironolactone, she said, nor does there appear to be a risk in lactating mothers. But the drug should not be taken during pregnancy or by women who could become pregnant, she noted.

    Dr. Harper warned against the use of tetracyclines and erythromycin estolate when treating pregnant women with acne. She avoids using topical retinoids, although she said they are probably safe in small areas. Benzoyl peroxide is acceptable for small areas, as are topical azelaic acid and clindamycin, she added.

    For information about acne treatment in lactating mothers, she cited a 2014 review (J Am Acad Dermatol. 2014 Mar;70:417.e1-417.e10.). Erythromycin, azithromycin, and clarithromycin are considered appropriate for short-term use, she said, as are tetracyclines, but for less than 3 weeks only. Oral clindamycin is acceptable, but may cause gastrointestinal side effects in the nursing infant; topical use appears to be appropriate, she said.

    Topical treatment with benzoyl peroxide is also appropriate for lactating women, she said, and topical retinoids are probably safe on small areas. Topical azelaic acid is considered a low risk to the nursing infant, she added.

    Dr. Harper disclosed financial relationships of various types with Allergan, Bayer, BiopharmX, Galderma, Novan, Promius and Valeant.

    SDEF and this news organization are owned by Frontline Medical Communications.

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