Drug Safety Information for LEVONORGESTREL (Levonorgestrel)

Safety-related Labeling Changes for JADELLE (LEVONORGESTREL) Discontinued Drug: FDA Link

Safety-related Labeling Changes for PLAN B (LEVONORGESTREL) Rx Drug: FDA Link

Safety-related Labeling Changes for MIRENA (LEVONORGESTREL) Rx Drug: FDA Link

Safety-related Labeling Changes for PLAN B ONE-STEP (LEVONORGESTREL) Over-the-counter Drug: FDA Link

Safety-related Labeling Changes for SKYLA (LEVONORGESTREL) Rx Drug: FDA Link

Safety-related Labeling Changes for LILETTA (LEVONORGESTREL) Rx Drug: FDA Link

Adverse Drug Reactions for LEVONORGESTREL* (Levonorgestrel)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with LEVONORGESTREL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Device expulsion25426
2Menstruation irregular*12896
3Device dislocation9022
4Abdominal pain5892
5Vaginal haemorrhage5617
7Uterine perforation4484
8Pelvic pain4439
10Abdominal pain lower4329
11Genital haemorrhage4327
13Medical device complication4052
14Procedural pain3497
15Pregnancy with contraceptive device3324
17Emotional distress2837

* This side effect also appears in "Top 10 Side Effects of LEVONORGESTREL " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking LEVONORGESTREL
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
2Post coital contraception40096
3Product used for unknown indication17425
6Menstrual cycle management575
7Menstruation irregular535
8Vaginal haemorrhage453
9Menstrual disorder321
10Oral contraception301

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for LEVONORGESTREL

Total Reports Filed with FDA: 229779

Number of FDA Adverse Event Reports by Patient Age for LEVONORGESTREL

Total Reports Filed with FDA: 229779*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Levonorgestrel (Norlevo, Norplant ii, Next choice one dose, Fallback solo, Opcicon one-step, Liletta, Take action, Plan b, Mirena, My way, Skyla, Microval, Lutera, Next choice, Norgeston, Jadelle, Plan b one-step, Levonorgestrel, Norplant)

Charts are based on 229779 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and LEVONORGESTREL Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

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