Norgestrel

OPILL

What it isProgestin used in combined and, at low dose, over-the-counter progestin-only contraception.

Why this oneIt is the first oral contraceptive available without prescription in the US.

What limits itThe progestin-only pill needs a narrow dosing window. Irregular bleeding.

FDA-approved for

FDA dosing	Population	Start	Target	Max
Contraception	Females of reproductive potential	1 tablet QD	1 tablet QD, continuous (no pack break)

Renal Undefined

Hepatic Undefined

Take 1 tablet at the same time every day
Use a barrier method for the first 48 hours after starting the first pack
If >3 hours late or a dose is missed, take one immediately, resume usual schedule, and use backup for the next 48 hours
If vomiting or severe diarrhea within 4 hours of a dose, use backup for 48 hours
When a pack finishes, start the next the following day with no break

Pregnancy Undefined

Lactation Undefined

NO BOXED WARNINGS

Principal riskA narrow dosing window for the progestin-only pill

Cost, est. cash$300–$2,500/month

Generic entry1999

Therapeutic safety burden2 / 4

Overdose danger1 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk0 / 4

Legacy pregnancy categoryX

Defining liabilityVenous thromboembolism and hormone-related adverse effects; estrogen also lowers lamotrigine exposure.

CYP3A4 substrate