Plan B One-steplevonorgestrel

Name: PLAN B ONE-STEP (levonorgestrel) — FDA Adverse Event Reports
Creator: PillSignal
License: https://open.fda.gov/license/

According to the FDA label: Use for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)

38,450 adverse event reports submitted to the FDA (2004–2026)

This data reflects voluntary reports submitted to the FDA's Adverse Event Monitoring System (AEMS), formerly the FDA Adverse Event Reporting System (FAERS). A report does not mean the medication caused the event. Data may be incomplete or contain errors. Learn more about AEMS. New to this data? Read our guide on how to interpret FDA adverse event reports →

New to FDA adverse event data? Here's how to read these reports →

Top Reported Adverse Events

The most frequently reported events in association with Plan B One-step in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.

Show these terms with plain-language definitions

Tap any term below for a plain-language definition.

Menstruation Irregular 13,231 reports
Vaginal Haemorrhage 6,805 reports
Vaginal bleeding, particularly heavy or unexpected bleeding. Also spelled hemorrhage in American English.
Full definition in the glossary →
Nausea 4,445 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →
Menstruation Delayed 4,399 reports
Dysmenorrhoea 3,363 reports
Vomiting 2,930 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →
Pelvic Pain 2,206 reports
Headache 2,098 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →
Fatigue 1,857 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →
Drug Ineffective 1,725 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →
Pregnancy After Post Coital Contraception 1,720 reports
Dizziness 1,696 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →
Abdominal Pain 1,521 reports
Pain in the belly or stomach area.
Full definition in the glossary → See all drugs reporting this event →
Breast Tenderness 1,477 reports
Vaginal Discharge 1,467 reports

Browse the full glossary →

Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.

Who Is Reporting

Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.

By Sex

View reporter sex data as a table

Plan B One-step adverse event reports by reporter sex
Sex	Reports
Female	38,123
Male	44
Unknown	40

By Age Group

View age group data as a table

Plan B One-step adverse event reports by reporter age group
Age group	Reports
0-17	1,900
18-34	12,462
35-49	2,181
50-64	157
65-74	8
75+	4

This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.

Reported Outcomes

Outcomes recorded in FAERS reports that included Plan B One-step. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.

View outcome data as a table

Plan B One-step adverse event reports by reported outcome
Outcome	Reports
Non-Serious	34,367
Other Serious	3,637
Hospitalization	650
Life-Threatening	134
Disability	101
Death	58

Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.

Report Volume Over Time

Number of FAERS reports received per quarter for Plan B One-step. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.

View report trend as a table

Plan B One-step adverse event reports by year
Year	Reports
2004	39
2005	39
2006	37
2007	27
2008	22
2009	50
2010	85
2011	6,105
2012	4,980
2013	4,225
2014	4,305
2015	3,556
2016	3,120
2017	2,159
2018	1,459
2019	2,247
2020	1,817
2021	533
2022	1,072
2023	889
2024	863
2025	694
2026 (partial)	127

The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.

Other medications with similar adverse event profiles in FDA FAERS reports.

Data Source

This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.

View this data on the FDA website →

Data last updated: June 2026