Levonorgestrel

Common brands: Mirena, Plan B One-Step, Liletta, Kyleena, Skyla

Top reporter: Bayer Healthcare Pharmaceuticals Inc.

Progestin [EPC]Progestin-containing Intrauterine System [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Benzodiazepine [EPC]Provitamin D2 Compound [EPC]
198,676
Total Reports
33,742
Serious Reports
267
Death Reports
30
Reported Reactions
Death Report Ratio: Low (0.13%)

Patient Demographics

Male
1,685
Female
195,667

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Levonorgestrel.

# Reaction Reports % of Total
1 DEVICE EXPULSION 45,198
17.8%
2 DEVICE DISLOCATION 20,183
8.0%
3 MENSTRUATION IRREGULAR 15,004
5.9%
4 VAGINAL HAEMORRHAGE 14,876
5.9%
5 GENITAL HAEMORRHAGE 11,020
4.3%
6 ABDOMINAL PAIN LOWER 9,229
3.6%
7 ABDOMINAL PAIN 8,567
3.4%
8 NAUSEA 8,489
3.3%
9 PROCEDURAL PAIN 8,357
3.3%
10 PAIN 7,505
3.0%
11 UTERINE PERFORATION 7,425
2.9%
12 DRUG INEFFECTIVE 7,039
2.8%
13 PELVIC PAIN 6,828
2.7%
14 HEADACHE 6,432
2.5%
15 PREGNANCY WITH CONTRACEPTIVE DEVICE 5,914
2.3%
16 MENSTRUATION DELAYED 5,752
2.3%
17 COMPLICATION OF DEVICE INSERTION 5,611
2.2%
18 INTRA-UTERINE CONTRACEPTIVE DEVICE EXPELLED 5,573
2.2%
19 FATIGUE 5,221
2.1%
20 DYSMENORRHOEA 5,026
2.0%
21 ANXIETY 4,831
1.9%
22 DEPRESSION 4,820
1.9%
23 AMENORRHOEA 4,784
1.9%
24 VOMITING 4,654
1.8%
25 INJURY 4,599
1.8%
26 MENORRHAGIA 4,430
1.7%
27 DIZZINESS 4,209
1.7%
28 DEVICE DIFFICULT TO USE 4,179
1.6%
29 BACK PAIN 3,872
1.5%
30 WEIGHT INCREASED 3,843
1.5%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.