HIGH-VOLUME · FEMALE-LED
levonorgestrel Side Effects
levonorgestrel (also sold as Plan B, Mirena) is HIGH-VOLUME in this FAERS book #29 of 524 by FAERS report count. Signature opener: FEMALE-LED - 99% of sex-coded reports are female (194,108 F / 1,680 M).
Data updated 2026-05-15
- 197,074
- FAERS reports
FAERS voluntary reports, 2004 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
levonorgestrel reporting skew - 99% of sex-coded reports are female (194,108 F / 1,680 M). Volume band HIGH-VOLUME #29 of 524 by FAERS report count; caseload MEGA-CASE.
High-report extract for levonorgestrel (Plan B): 197,074 FAERS rows (2004-2025). Top named reactions: DEVICE EXPULSION, DEVICE DISLOCATION, MENSTRUATION IRREGULAR. Outcome stamps DEATH-RARE · HOSP-LIGHT · FEMALE-LED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2004–2025). Stamps MEGA-CASE · DEATH-RARE · HOSP-LIGHT · FEMALE-LED.
DEVICE EXPULSION leads 44,866 of 197,074 reports
FEMALE-LED reporters · age peak 18-44
Female-led reporters (99% of sex-coded rows)
Age peak 18-44 (106,973 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death is rare in this extract (267 / 197,074). Co-reported reactions in that thin subset:
| 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
Hospitalization is lighter here (10,709). Reactions in that subset:
| 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 |
How to read levonorgestrel FAERS figures (MEGA-CASE · DEATH-RARE · HOSP-LIGHT)
FAERS holds 197,074 voluntary reports linked to levonorgestrel (Plan B, Mirena), 2004-2025. Death is listed on 267 (0.1%). Hospitalization appears on 10,709 (5.4%). Top co-reported indication: Contraception.
MEGA-CASE books overweight common drugs and loud reporting cultures; FEMALE-LED is the page opener, not a per-patient risk.
Read with levonorgestrel
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-RARE · HOSP-LIGHT stamps.
ABS(total_reports) peer at 197,405 FAERS cases (Δ 331 heavier vs levonorgestrel); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's MEGA-CASE · DEATH-RARE · HOSP-LIGHT · FEMALE-LED.
ABS(total_reports) peer at 196,342 FAERS cases (Δ 732 lighter vs levonorgestrel); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's MEGA-CASE · DEATH-RARE · HOSP-LIGHT · FEMALE-LED.
ABS(total_reports) peer at 194,743 FAERS cases (Δ 2,331 lighter vs levonorgestrel); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-RARE · HOSP-LIGHT · FEMALE-LED.
ABS(total_reports) peer at 200,719 FAERS cases (Δ 3,645 heavier vs levonorgestrel); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-RARE · HOSP-LIGHT · FEMALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 62.0 pp vs levonorgestrel's DEATH-RARE): CASELOAD · HOSP-MID.
levonorgestrel sits in MEGA-CASE; high report volume tracks exposure and reporting culture more than per-patient risk. Methodology states the de-dup rules.