Active substance
Megestrol
- SFDA 2
- US FDA 18
- Health Canada 2
- US price lines 5
- NHS prices 1
- Safety 6
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| MEGACE | 40 mg | Capsule · Oral use | 100 Tablet Container | SAR 140.60 | NCE · Prescription | MEADJOHNSON | Invalid · Not Marketed |
| MEGACE | 20 mg | Capsule · Oral use | 100 Tablet Container | SAR 81.15 | NCE · Prescription | MEADJOHNSON | Invalid · Not Marketed |
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| MEGESTROL ACETATE | 20MG | tablet · oral | STRIDES PHARMA INTL | Prescription | 8 Aug 1988 |
| MEGESTROL ACETATE | 40MG | tablet · oral | STRIDES PHARMA INTL | Prescription | 8 Aug 1988 |
| MEGESTROL ACETATE | 40MG; 20MG | tablet · oral | BARR | Prescription | 30 Nov 1995 |
| MEGESTROL ACETATE | 40MG/ML | suspension · oral | STRIDES PHARMA INTL | Prescription | 25 Jul 2001 |
| MEGESTROL ACETATE | 40MG/ML | suspension · oral | PHARMOBEDIENT | Prescription | 1 Nov 2004 |
| MEGESTROL ACETATE | 40MG/ML | suspension · oral | NOVITIUM PHARMA | Prescription | 16 Feb 2006 |
| MEGESTROL ACETATE | 125MG/ML | suspension · oral | TWI PHARMS | Prescription | 27 Aug 2014 |
| MEGACE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | BRISTOL MYERS SQUIBB | Discontinued | 18 Aug 1971 |
| MEGACE | 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | suspension · oral | BRISTOL MYERS SQUIBB | Discontinued | 10 Sep 1993 |
| MEGESTROL ACETATE | 20MG; 40MG | tablet · oral | HIKMA PHARMS | Discontinued | 29 Sep 1995 |
| MEGESTROL ACETATE | 40MG | tablet · oral | TEVA | Discontinued | 27 Feb 1998 |
| MEGESTROL ACETATE | 40MG/ML | suspension · oral | HIKMA PHARMS | Discontinued | 15 Feb 2002 |
| MEGESTROL ACETATE | 40MG/ML | suspension · oral | TEVA PHARMS | Discontinued | 5 May 2003 |
| MEGACE ES | 125MG/ML | suspension · oral | ENDO OPERATIONS | Discontinued | 5 Jul 2005 |
| MEGESTROL ACETATE | 40MG/ML | suspension · oral | HIKMA PHARMS | Discontinued | 9 Jun 2017 |
| MEGESTROL ACETATE | 125MG/ML | suspension · oral | CHARTWELL | Discontinued | 1 Dec 2017 |
| MEGESTROL ACETATE | 20MG | tablet · oral | USL PHARMA | Discontinued | |
| MEGESTROL ACETATE | 40MG | tablet · oral | USL PHARMA | Discontinued |
Canada Canada — marketed products (Health Canada)
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | MEGESTROL 20 MG TABLET | $0.19502 | per EA | 23 Sep 2026 |
| US NADAC | MEGESTROL 40 MG TABLET | $0.24078 | per EA | 23 Sep 2026 |
| US NADAC | MEGESTROL 625 MG/5 ML SUSP | $1.44029 | per ML | 23 Sep 2026 |
| US NADAC | MEGESTROL ACET 40 MG/ML SUSP | $0.13605 | per ML | 23 Sep 2026 |
| US NADAC | MEGESTROL ACET 40 MG/ML SUSP | $0.12905 | per ML | 23 Sep 2026 |
| NHS Drug Tariff | Megestrol 160mg tablets | £19.52 | 30 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- EMA PRAC 31 Aug 2023 PRAC signal: Meningioma
Action for MAH: update of the product information: No - EMA PRAC 14 Apr 2023 PRAC signal: Meningioma
Action for MAH: update of the product information: No - US FDA 18 Jul 2019 MEGACE — safety-related labeling change
Labeling sections changed: Drug Interactions - US FDA 18 Dec 2018 MEGACE ES — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 11 Jan 2018 PRAC signal: Drug interaction leading to elevated international normalised ratio (INR)/ haemorrhage with megestrol and vitamin K antagonists
Action for MAH: update of the product information: No - EMA PRAC 1 Sep 2017 PRAC signal: Drug interaction leading to elevated international normalised ratio (INR)/ haemorrhage with megestrol and vitamin K antagonists
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.