Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (2)
- etrasimod
etrasimod, megestrol. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Risk of additive immune system effects with etrasimod has not been studied in combination with antineoplastic, immune-modulating, or noncorticosteroid immunosuppressive therapies. Avoid coadministration during and in the weeks following administration of etrasimod.
- 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.
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
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
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.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%)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| megestrol oral - | 40 mg tablet |  | |
| megestrol oral - | 400 mg/10 mL (40 mg/mL) suspension |  | |
| megestrol oral - | 20 mg tablet |  | |
| megestrol oral - | 400 mg/10 mL (40 mg/mL) suspension |  | |
| 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 - | 625 mg/5 mL (125 mg/mL) suspension |  | |
| megestrol oral - | 625 mg/5 mL (125 mg/mL) suspension |  | |
| megestrol oral - | 400 mg/10 mL (40 mg/mL) suspension |  | |
| megestrol oral - | 400 mg/10 mL (40 mg/mL) suspension |  | |
| megestrol oral - | 20 mg tablet |  | |
| megestrol oral - | 40 mg tablet |  | |
| megestrol oral - | 400 mg/10 mL (10 mL) suspension |  | |
| megestrol oral - | 400 mg/10 mL (10 mL) suspension |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
megestrol oral
MEGESTROL SUSPENSION - ORAL
(me-JES-trol)
COMMON BRAND NAME(S): Megace
USES: Megestrol is used to treat loss of appetite and weight loss in people with AIDS. Improving your appetite and gaining weight may help you feel better and be more active.Megestrol is similar to a natural substance made by the body called progesterone.
HOW TO USE: Take this medication by mouth as directed by your doctor, usually once daily. Shake the bottle well before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.Do not switch between different liquid forms of megestrol because you may not get the correct dose.The dosage is based on your medical condition and response to treatment.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time 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 may harm an unborn baby, women who are pregnant or who may become pregnant should handle this medication carefully. Wash your skin well right away if megestrol gets on your skin.It may take up to several weeks before you get the full benefit of this drug.Tell your doctor if you do not get better or if you get worse.
SIDE EFFECTS: Trouble sleeping, fever, gas, decreased sexual ability/desire, or upset stomach may occur. Women may have changes in their menstrual periods, such as 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, tiredness, 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 heart failure), high blood pressure, kidney disease, 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.This medication must not be used during pregnancy. It may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.This medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.
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, 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 October 2023. Copyright(c) 2023 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.
Formulary
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