PROGESTERONE
Generic: PROGESTERONE
AvKAREManufacturer
ORALRoute
PROGESTERONEActive Substance
2017-10-20Original Approval
PROGESTERONE is FDA application ANDA205229, sponsored by XIROMED. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class II2024-07-26
Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Mfd. in India for: Eugia US Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Class II2021-02-26
Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Distributed by: Dr. Reddy's Laboratories, IncFailed Dissolution Specifications: Out-of-specification results observed for dissolution during stab
Class II2024-12-27
Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLPresence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Top Reported Reactions
1
HEADACHE
1,744 reports
2
OFF LABEL USE
1,594 reports
3
DRUG INEFFECTIVE
1,557 reports
4
FATIGUE
1,497 reports
5
PAIN
1,247 reports
6
NAUSEA
1,237 reports
7
FOETAL EXPOSURE DURING PREGNANCY
868 reports
8
EXPOSURE DURING PREGNANCY
863 reports
9
RASH
851 reports
10
DIZZINESS
776 reports