Norgestrel
/api/v1/drug/norgestrelMechanism of action
Sourced from openFDAMechanism-of-action class: Progestational Hormone Receptor Agonists.
Indications
Sourced from openFDA- Use To prevent pregnancy
Dosage & administration
Sourced from openFDADirections 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 openFDAAllergy 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
- 1Heavy Menstrual Bleeding24511%
- 2Pregnancy On Oral Contraceptive2099.4%
- 3Intermenstrual Bleeding1828.2%
- 4Polymenorrhoea1577.1%
- 5Nausea1366.1%
- 6Headache1315.9%
- 7Drug Ineffective1305.8%
- 8Product Dose Omission Issue1004.5%
- 9Fatigue843.8%
- 10Weight Increased763.4%
- 11Adverse Drug Reaction733.3%
- 12Muscle Spasms683.1%
- 13Rash683.1%
- 14Vaginal Haemorrhage673.0%
- 15Product Quality Issue642.9%
Literature
Recent PubMed references pinned to Norgestrel as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Short fibers recruiting inflammatory exudate via smart-responsive estrogen antagonism for endometrial hyperplasia.Biomaterials · 2026 · Liu M, Zhou Y, Kang H, et al.PMID 42155173DOI 10.1016/j.biomaterials.2026.124306
- Levonorgestrel intrauterine system: do the contraceptive benefits outweigh the risks in light of new FSRH guidance?The British journal of general practice : the journal of the Royal College of General Practitioners · 2026 · Joseph APMID 42134930DOI 10.3399/bjgp26X745389
- Preliminary Evaluation of Leuprorelin Acetate Microspheres Plus Levonorgestrel-Releasing Intrauterine System in Endometriosis: An Exploratory Study Focusing on BNIP3 and EPAC1 Expression.The journal of obstetrics and gynaecology research · 2026 · Liu J, Li M, Zhang J, et al.PMID 42120175DOI 10.1111/jog.70304
- Assessment of the Drug-Drug Interaction Potential of Lotiglipron (PF-07081532) with Midazolam, Omeprazole, Dabigatran, Rosuvastatin, and the Oral Contraceptives Levonorgestrel and Ethinyl Estradiol.Journal of clinical pharmacology · 2026 · Cronenberger C, Amin NB, Le VH, et al.PMID 42053447DOI 10.1002/jcph.70158
- Life-time levonorgestrel exposure causes intergenerational alterations of the thyroid-catecholaminergic-GABAergic functional network in zebrafish (Danio rerio).Environmental research · 2026 · Hu X, Cai Q, Wu J, et al.PMID 42031046DOI 10.1016/j.envres.2026.124496
- Differences in Physiologically Based Pharmacokinetic Predictions between Software Platforms Can Be Clinically Relevant: Cases of Levornestrogel and Ethinylestradiol Concentrations with SIMCYP versus PK-Sim from a User Perspective.European journal of drug metabolism and pharmacokinetics · 2026 · Massaux C, Dogné JM, Musuamba FT, et al.PMID 41934490DOI 10.1007/s13318-026-00988-1
- Differential regulation of endometrial receptivity markers by levonorgestrel-releasing and copper intrauterine devices: A cross-sectional study.Journal of gynecology obstetrics and human reproduction · 2026 · Karakelleoğlu GPMID 41921785DOI 10.1016/j.jogoh.2026.103171
- Association of Levonorgestrel-Containing Emergency Contraceptive Pills with Breast Cancer in Premenopausal Latin American Women: The PRECAMA Study.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2026 · Cabrera-López M, Ángeles-Llerenas A, de la Vara-Salazar E, et al.PMID 41879672DOI 10.1158/1055-9965.EPI-25-1235
Clinical trials
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.
- Weight Management Plus LNG-IUS/Megestrol Acetate in Endometrial Atypical HyperplasiaRecruiting · Phase 2 · Phase 3 · Interventional · 172 enrolled · Xiaojun ChenNCT05316493updated 2026-06-04
- Effects of Copper Versus Levonorgestrel Intrauterine Devices on Mucosal Microbiota and Barrier Function Among Young African WomenNot yet recruiting · Interventional · 120 enrolled · Seattle Children's HospitalNCT07627958updated 2026-06-04
- Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency ContraceptionRecruiting · Phase 3 · Interventional · 980 enrolled · The University of Hong KongNCT06727734updated 2026-05-14
- A Study to Investigate the Effect of AZD6234, AZD9550, and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or ObesityRecruiting · Phase 1 · Interventional · 50 enrolled · AstraZenecaNCT07013643updated 2026-05-11
- A Phase 1 Study to Assess the Effect of ABBV-722 on Ethinyl Estradiol and Levonorgestrel Drug Levels in Healthy Adult Female ParticipantsRecruiting · Phase 1 · Interventional · 16 enrolled · AbbVieNCT07502417updated 2026-04-28
- A Study of ABBV-295 Subcutaneous Injections to Assess Pharmacokinetics and Adverse Events in Healthy Adult Women Participants With Overweight or Obesity Taking Oral ContraceptivesActive not recruiting · Phase 1 · Interventional · 20 enrolled · AbbVieNCT07414784updated 2026-04-27
- A Study of Elenestinib in Healthy Adult Female ParticipantsCompleted · Phase 1 · Interventional · 20 enrolled · Blueprint Medicines CorporationNCT07388511updated 2026-04-20
- Levonorgestrel 52 mg IUD for Emergency Contraception and Same-Day StartRecruiting · Phase 4 · Interventional · 1,404 enrolled · University of UtahNCT05444582updated 2026-04-16
- Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Ethinyl Estradiol/Levonorgestrel (EE/LNG)Completed · Phase 1 · Interventional · 24 enrolled · Atea Pharmaceuticals, Inc.NCT07272889updated 2026-04-13
- Kuwa Free! - Live Free!Recruiting · Interventional · 700 enrolled · University of Alabama at BirminghamNCT05044962updated 2026-04-13
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.
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.