NORGESTIMATE AND ETHINYL ESTRADIOL (Norgestimate and Ethinyl Estradiol)
What to know about NORGESTIMATE AND ETHINYL ESTRADIOL — also sold as Norgestimate and Ethinyl Estradiol: uses, side effects, interactions, and safety considerations for people taking it or caring for someone who is.
NORGESTIMATE AND ETHINYL ESTRADIOL (brand names: Norgestimate and Ethinyl Estradiol) is classified as Low risk (1 risk points) by AllMeds. It is a S4 medication under the TGA in Australia. FDA approved in the United States. Combined hormonal contraceptive with minimal impact on work capacity or cognitive function.
Key Takeaways
- TGA Schedule: S4 in Australia
- Risk level: Low (1 points)
Scheduling and Classification
| Jurisdiction | Classification | Status |
|---|---|---|
| Australia (TGA) | S4 | Not PBS listed |
| United States (FDA) | Rx only | FDA approved |
Risk Profile
Combined hormonal contraceptive with minimal impact on work capacity or cognitive function.
How NORGESTIMATE AND ETHINYL ESTRADIOL is regulated
NORGESTIMATE AND ETHINYL ESTRADIOL is overseen by medicines regulators in each country. The rules below explain how it's scheduled, what oversight applies, and what to discuss with your doctor or pharmacist before starting, changing, or stopping this medication.
Australia TGA / PBS / State Schemes
Classified as S4 under the Therapeutic Goods Administration (TGA).
United States FDA / CDC / State WC
FDA approved for use in the United States.
FDA Boxed Warning: WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke [see Contraindications ( 4 )]. WARNING: CIGARETTE SMOKING and SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. Sprintec is contraindicated in women over 35 years old who smoke. (4) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. (4)
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Important: This page is general health information, not personal medical advice. If you have questions about your medication — including starting it, stopping it, changing the dose, or combining it with something else — speak with your doctor or pharmacist. For an emergency or suspected overdose, call your local emergency number or poison information service immediately. Information is drawn from regulator and clinical guideline sources (TGA, FDA, MHRA, NICE, PBS, CDC); see our methodology for details.