Prescription medicine
Megestrol First approved as Megace
Megestrol (Megace) is a prescription medicine with an FDA approval on record since 1971. FDA's NDC Directory lists it from 17 generic labelers, and pharmacies paid $0.241 per megestrol 40 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the megestrol FDA label on DailyMed (effective April 22, 2022, Strides Pharma Science Limited); the NDA 16979 record on Drugs@FDA; every megestrol label on DailyMed.
Highlights of the record
FDA label of April 22, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageMegestrol acetate oral suspension, USP is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).
Forms and strengths
- 20 mg
- 40 mg
- 40 mg/ml
- 125 mg/ml
- 400 mg/10ml
Suspension; tablet.
On the market
- Earliest approval on file
- August 18, 1971 Megace, Bristol Myers Squibb; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first August 8, 1988; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 17 of which 17 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.241 per tablet Megestrol 40 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2018 0 Class I among all firms' recalls; latest April 26, 2023
- FAERS reports
- 3,841 through July 30, 2026
What is megestrol used for?
From the label: indications and usageMegestrol acetate oral suspension, USP is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).
FDA pharmacologic class: Progestin.
Source: FDA drug label (Megestrol Acetate), Strides Pharma Science Limited, effective April 22, 2022 (SPL set 9f7365a0-67cf-45fc-a914-e40a4507a063), via openFDA; the full label on DailyMed
Is there a generic for megestrol (Megace)?
The FDA approved the first generic megestrol on August 8, 1988. 13 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists megestrol from 17 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1971 earliest approval on file
- 1988 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for megestrol (Megace)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.241 per Megestrol 40 mg tablet, up 10% from $0.219 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Megestrol 40 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Megestrol 20 mg tablet | Generic | $0.195 per tablet | $5.85 | +22% |
| Megestrol 40 mg tablet | Generic | $0.241 per tablet | $7.22 | +10% |
| Megestrol 625 mg/5 mL suspension | Generic | $1.44 per mL | n/a | +21% |
| Megestrol acet 40 mg/mL suspension | Generic | $0.133 per mL | n/a | +0.4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has megestrol been recalled?
The FDA's Enforcement Report lists 4 recalls naming megestrol since 2018: 0 Class I (the most serious), 2 Class II, 2 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 26, 2023 | Class II | Akorn, Inc. | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| November 6, 2018 | Class III | Breckenridge Pharmaceutical, Inc. | Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing. |
| August 14, 2018 | Class II | Mckesson Corporation | Supterpotent Drug |
| January 29, 2018 | Class III | Mckesson Packaging Services | Subpotent Drug: Out of specification for assay (stability testing) |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the megestrol label say about other medicines?
The megestrol label names no other medicine on this site. The labels of 2 other medicines name megestrol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name megestrol
Source: FDA drug label (Megestrol Acetate), Strides Pharma Science Limited, effective April 22, 2022 (SPL set 9f7365a0-67cf-45fc-a914-e40a4507a063), via openFDA; the full label on DailyMed
What do FAERS reports show for megestrol?
The FDA Adverse Event Reporting System holds 3,841 reports that list megestrol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 956 are coded as a death and 1,783 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other progestins
- the pharmacologic class, with prices and generics
- Megestrol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other