pharmacopeia
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/api/v1/drug/norgestrel

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Progestational Hormone Receptor Agonists.

Progestational Hormone Receptor

Indications

Sourced from openFDA
  • Use To prevent pregnancy

Dosage & administration

Sourced from openFDA

Directions take 1 tablet at the same time every day this product will work best to prevent pregnancy when taken exactly as directed you can start on any day of the month use a condom (or another barrier method) every time you have sex during the first 2 days of use (48 hours) after you start your first pack of this product, because it takes 2 days for this product to start working See the enclosed leaflet for more information on how to switch from another contraceptive method. never skip your daily tablet to prevent pregnancy, take this product every day, even when you bleed or have spotting when you finish this pack, start the next one the following day without a break if you are more than 3 hours late taking your tablet or miss taking your tablet on 1 more days: take 1 tablet immediately, as soon as you remember that you missed it then go back to taking your daily tablet at your usual time use a condom (or another barrier method) every time you have sex during the next 2 days (48 hours), because it takes 2 days for this product to start working again if you vomit for any reason or have severe diarrhea within 4 hours of taking your daily tablet, use a condom (or another barrier method) every time you have sex for the next 2 days (48 hours), because the medicine may not have been fully absorbed you should continue to see your healthcare provider(s) for routine healthcare visits When to use a condom (or another barrier method) every time you have sex for the next 2 days (48 hours): after you start your first pack of this product if you take a tablet more than 3 hours late or…

Warnings & precautions

Sourced from openFDA

Allergy alert: Do not use if you are allergic to this product or any of its ingredients, such as FD&C yellow No. 5 (tartrazine). People allergic to aspirin often have a tartrazine allergy too. Symptoms may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, blisters. If an allergic reaction occurs, stop use and seek medical help right away. Sexually transmitted diseases (STDs) alert: This product does not protect against HIV/AIDS or other STDs. Do not use if you have or ever had breast cancer if you are already pregnant or think you may be pregnant together with another birth control pill, vaginal ring, patch, implant, injection or an IUD (intra-uterine device) as an emergency contraceptive (morning after pill). This product does not prevent pregnancy when used after unprotected sex if you are male Ask a doctor before use if you currently have vaginal bleeding between your periods and you have not already talked to a doctor you have liver problems you have or ever had any cancer Ask doctor or pharmacist before use if you are taking a prescription drug for seizures, tuberculosis, HIV/AIDS, pulmonary hypertension you are taking a supplement containing St John’s Wort (an herbal ingredient) if you have taken ulipristal acetate (an emergency contraceptive, or morning after pill) in the past 5 days See the enclosed leaflet for a detailed list of medicines that may interact with this product.

Approval history

Sourced from openFDA
  • Oct 23, 1973NDANDA017031Laboratoire Hra
  • Jul 28, 1999ANDAANDA075288Dr Reddys Labs Sa
  • Nov 30, 2001ANDAANDA075840Duramed Pharms Barr
  • Mar 28, 2012ANDAANDA091105Novast Labs Ltd
  • Jul 31, 2023ANDAANDA202980Lupin

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
2,223 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Heavy Menstrual Bleeding24511%
  2. 2Pregnancy On Oral Contraceptive2099.4%
  3. 3Intermenstrual Bleeding1828.2%
  4. 4Polymenorrhoea1577.1%
  5. 5Nausea1366.1%
  6. 6Headache1315.9%
  7. 7Drug Ineffective1305.8%
  8. 8Product Dose Omission Issue1004.5%
  9. 9Fatigue843.8%
  10. 10Weight Increased763.4%
  11. 11Adverse Drug Reaction733.3%
  12. 12Muscle Spasms683.1%
  13. 13Rash683.1%
  14. 14Vaginal Haemorrhage673.0%
  15. 15Product Quality Issue642.9%

Literature

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Recent PubMed references pinned to Norgestrel as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 205 ClinicalTrials.gov registrations naming Norgestrel as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Norgestrel work?
Mechanism-of-action class: Progestational Hormone Receptor Agonists.
What is Norgestrel used for?
According to FDA labeling, Norgestrel carries indications including: Use To prevent pregnancy. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Norgestrel?
Norgestrel is classified as Progestational Hormone Receptor Agonists, Increased Blood Pressure, Increased Coagulation Activity.
Note. Data for norgestrel is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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