Drug side effects
levonorgestrel Side Effects
The reactions most often reported to the FDA for levonorgestrel (also sold as Plan B, Mirena), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 197,074
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2004 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of levonorgestrel come from 197,074 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 197,074 reports to the FDA Adverse Event Reporting System (FAERS) for levonorgestrel (Plan B): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
197,074
Reports Mentioning Death
267
0.1% of reports — not proof the medicine caused the death
Hospitalizations
10,709
5.4% of reports
Top Indication
Contraception
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 267 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 52 |
| FOETAL EXPOSURE DURING PREGNANCY | 21 |
| PREMATURE BABY | 16 |
| COMPLETED SUICIDE | 15 |
| PAIN | 13 |
| SEPSIS | 13 |
| ABDOMINAL PAIN | 11 |
| ANXIETY | 11 |
| DEPRESSION | 11 |
| DEHYDRATION | 9 |
| FOETAL DEATH | 9 |
| PREGNANCY WITH CONTRACEPTIVE DEVICE | 9 |
| PULMONARY EMBOLISM | 9 |
| PYREXIA | 9 |
| CARDIAC ARREST | 8 |
| DRUG EXPOSURE DURING PREGNANCY | 8 |
| DYSPNOEA | 8 |
| FATIGUE | 8 |
| HEADACHE | 8 |
| VOMITING | 8 |
Reactions in Hospitalization Reports
Top reactions in 10,709 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| UTERINE PERFORATION | 3,146 |
| INJURY | 3,018 |
| PAIN | 2,310 |
| EMOTIONAL DISTRESS | 1,857 |
| ANXIETY | 1,800 |
| DEVICE DISLOCATION | 1,667 |
| ABDOMINAL PAIN | 1,651 |
| DEVICE ISSUE | 1,610 |
| DEPRESSION | 1,492 |
| ABDOMINAL PAIN LOWER | 1,130 |
| PELVIC PAIN | 1,031 |
| GENITAL HAEMORRHAGE | 983 |
| PREGNANCY WITH CONTRACEPTIVE DEVICE | 769 |
| PROCEDURAL PAIN | 739 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 641 |
| DEVICE DIFFICULT TO USE | 614 |
| EMBEDDED DEVICE | 573 |
| MEDICAL DEVICE DISCOMFORT | 571 |
| VAGINAL HAEMORRHAGE | 564 |
Nearby, Related Medications
What the FAERS Data Reveals About levonorgestrel Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 197,074 voluntary reports linked to levonorgestrel and its brand equivalents (Plan B, Mirena), spanning 2004 through 2025. Of those, 267 (0.1%) listed death as an outcome and 10,709 (5.4%) involved hospitalization. The most common indication reported alongside adverse events was Contraception.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 99% were female and 1% male; age distribution skews toward 18-44, with 106,973 reports in that bracket. The single most reported reaction is device expulsion with 44,866 submissions, followed by device dislocation and menstruation irregular.
How to read these numbers
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to levonorgestrel's 197,074.
Read our methodology - how this data is sourced, computed, and verified.