megestrol (Rx)

Brand and Other Names:Megace, Megace ES
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 20mg
  • 40mg

oral suspension

  • 200mg/5mL
  • 625mg/5mL

AIDS-Related Cachexia

Megace: 800 mg/day PO

Megace ES: 312.5-625 mg/day PO

Breast Cancer

40 mg PO q6hr

Endometrial Cancer

40-320 mg/day PO in divided doses; evaluate efficacy after 2 months of treatment; up to 800 mg/day may be used

Cancer-Related Cachexia (Off-label)

480-600 mg/day PO

Dosing Modifications

Renal impairment: Use with caution; in normal renal function, 57-78% is excreted in urine within 10 days

Safety and efficacy not established

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Interactions

Interaction Checker

and megestrol

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (1)

              • mavacamten

                mavacamten will decrease the level or effect of megestrol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Progestin and ethinyl estradiol are CYP3A4 substrates. Mavacamten may decrease systemic exposures of ethinyl estradiol and progestin, which may lead to contraceptive failure or an increase in breakthrough bleeding. Advise patients to use a contraceptive method that is not affected by CYP450 enzyme induction (eg, intrauterine system) or add nonhormonal contraception (eg, condoms) during coadministration and for 4 months after last mavacamten dose.

              Monitor Closely (5)

              • insulin degludec

                megestrol decreases effects of insulin degludec by pharmacodynamic antagonism. Use Caution/Monitor. Progestins may impair glucose tolerance.

              • insulin degludec/insulin aspart

                megestrol decreases effects of insulin degludec/insulin aspart by pharmacodynamic antagonism. Use Caution/Monitor. Progestins may impair glucose tolerance.

              • insulin inhaled

                megestrol decreases effects of insulin inhaled by pharmacodynamic antagonism. Use Caution/Monitor. Progestins may impair glucose tolerance.

              • siponimod

                siponimod and megestrol both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • warfarin

                megestrol increases effects of warfarin by unspecified interaction mechanism. Use Caution/Monitor.

              Minor (2)

              • maitake

                maitake increases effects of megestrol by pharmacodynamic synergism. Minor/Significance Unknown. Maitake mushroom has anti-tumor effects (animal/in vitro research).

              • taurine

                megestrol decreases levels of taurine by unspecified interaction mechanism. Minor/Significance Unknown.

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              Adverse Effects

              Frequency Not Defined

              Common

              • Hypertension
              • Insomnia, mood swings
              • Rash, sweating
              • Amenorrhea, breakthrough bleeding, change in menstrual flow, hot sweats, impotence, spotting
              • Diarrhea, flatulence, indigestion, nausea, vomiting, weight gain

              Serious

              • Deep vein thrombosis (DVT)
              • Pulmonary embolism
              • Thrombophlebitis
              • Anemia
              • Adrenal insufficiency

              Postmarketing report

              Asthenia, rash, impotence

              Overdose may cause shortness of breath, cough, unsteady gait, listlessness, chest pain

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              Warnings

              Contraindications

              Known or suspected pregnancy

              Acute thrombophlebitis, thromboembolic disorder, breast cancer

              Undiagnosed abnormal genital bleeding

              Prophylaxis of weight loss

              Documented hypersensitivity

              May induce vaginal bleeding in women

              Cautions

              Diabetes mellitus

              History of thromboembolic disease

              Not to be used as prophylaxis against weight loss or as diagnostic test for pregnancy

              Adrenal insufficiency may occur in patients receiving or being withdrawn from long-term megestrol treatment

              Megestrol is a progesterone derivative which may induce vaginal bleeding in women

              Cushing syndrome reported with thearpy

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              Pregnancy & Lactation

              Pregnancy

              Obtain a pregnancy test in females of reproductive potential prior to initiating treatment; advise females of reproductive potential to use effective contraception while taking drug

              There are no available human data to assess for any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes; advise a pregnant women of potential risk to fetus

              Pregnancy testing is recommended prior to treatment

              Contraception

              • Therapy may cause fetal harm when administered during pregnancy; advise females of reproductive potential to use effective contraception during treatment

              Animal data

              • Based on animal data, megestrol acetate may cause fetal harm when administered to a pregnant woman and is contraindicated during pregnancy; there are no adequate animal developmental toxicity data at clinically relevant doses; pregnant rats treated with low doses resulted in reduction in fetal weight and number of live births, and feminization of male fetuses at doses below maximum recommended clinical dosing based on body surface area

              Lactation

              The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1; the drug is present in human milk; there are no data on effects of drug on breastfed infant or on milk production; because of potential for HIV transmission and adverse effects on a breastfed infant, instruct mothers not to breastfeed if they are receiving therapy

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Progestin derivative with antiestrogenic properties; interferes with estrogen cycle, resulting in lower luteinizing hormone (LH) titer; antineoplastic properties may come from direct effect on endometrium through anti-LH effect mediated via pituitary

              Absorption

              Bioavailability: Well absorbed PO

              Peak plasma time: 1-3 hr (tablet); 3-5 hr (suspension)

              Metabolism

              Metabolized by liver

              Metabolites: Sulfate and glucuronide metabolites (inactive)

              Elimination

              Half-life: 13-105 hr (mean, 34 hr)

              Excretion: Urine (57-78%), feces (8-30%)

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              megestrol oral
              -
              40 mg tablet
              megestrol oral
              -
              400 mg/10 mL (40 mg/mL) suspension
              megestrol oral
              -
              400 mg/10 mL (40 mg/mL) suspension
              megestrol oral
              -
              625 mg/5 mL (125 mg/mL) suspension
              megestrol oral
              -
              625 mg/5 mL (125 mg/mL) suspension
              megestrol oral
              -
              20 mg tablet
              megestrol oral
              -
              400 mg/10 mL (10 mL) suspension
              megestrol oral
              -
              400 mg/10 mL (40 mg/mL) suspension
              megestrol oral
              -
              400 mg/10 mL (40 mg/mL) suspension
              megestrol oral
              -
              40 mg tablet
              megestrol oral
              -
              20 mg tablet
              megestrol oral
              -
              400 mg/10 mL (40 mg/mL) suspension
              megestrol oral
              -
              400 mg/10 mL (40 mg/mL) suspension
              megestrol oral
              -
              400 mg/10 mL (10 mL) suspension

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              megestrol oral

              MEGESTROL - ORAL

              (me-JES-trol)

              COMMON BRAND NAME(S): Megace

              USES: This medication is used to treat cancer of the breast or uterus. Megestrol is similar to a natural substance made by your body called progesterone.

              HOW TO USE: Take this medication by mouth as directed by your doctor. The dosage and how often you take this medication are based on your medical condition and response to treatment. Follow your doctor's instructions carefully.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

              SIDE EFFECTS: Trouble sleeping, fever, gas, decreased sexual ability/desire, weight gain, changes in appetite, or upset stomach may occur. Women may have changes in their menstrual periods, including unpredictable bleeding. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including: fast/pounding heartbeat, fatigue, headache, swelling of the hands/feet.This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.Get medical help right away if you have any very serious side effects, including: symptoms of a blood clot (such as chest pain, trouble breathing, pain/redness/swelling of arms or legs), confusion, mental/mood changes, weakness/numbness on one side of the body, trouble speaking, vision changes.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before taking megestrol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: adrenal gland problems (such as Cushing's syndrome), blood clots, diabetes, heart disease (such as congestive heart failure), high blood pressure, kidney disease, stomach or abdominal problems, unusual vaginal bleeding.If you have diabetes, this product may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar (see Side Effects section). Your doctor may need to adjust your diabetes medication, exercise program, or diet.Using megestrol for a long time may make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have recently stopped taking it. Tell your doctor right away if you develop unusual/extreme tiredness, dizziness, nausea, or vomiting.Older adults may be more sensitive to the side effects of this drug, especially the risk for blood clots.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using megestrol. Megestrol may harm an unborn baby. Your doctor may order a pregnancy test before starting this medication. Women of childbearing age should ask about reliable forms of birth control while taking this medication. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.This medication passes into breast milk. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: dofetilide.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: Do not share this medication with others.Lab and/or medical tests (such as blood pressure readings, blood sugar) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

              MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

              STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              Information last revised February 2022. Copyright(c) 2022 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

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              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.