Misoprostol

Common brands: Cytotec, Doxycycline, Doxycycline Hyclate, Oracea, Doxy 100

Top reporter: Pfizer Laboratories Div Pfizer Inc

Prostaglandin E1 Analog [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Tetracycline-class Drug [EPC]Corticosteroid [EPC]Progestin Antagonist [EPC]
9,596
Total Reports
2,235
Serious Reports
733
Death Reports
30
Reported Reactions
Death Report Ratio: High (7.64%)

Patient Demographics

Male
1,366
Female
7,522

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Misoprostol.

# Reaction Reports % of Total
1 HAEMORRHAGE 1,259
10.5%
2 ABORTION INCOMPLETE 1,159
9.6%
3 OFF LABEL USE 907
7.5%
4 FOETAL EXPOSURE DURING PREGNANCY 627
5.2%
5 PAIN 538
4.5%
6 ANAEMIA 511
4.3%
7 PREGNANCY 448
3.7%
8 NAUSEA 441
3.7%
9 DRUG INEFFECTIVE 429
3.6%
10 VOMITING 422
3.5%
11 MATERNAL EXPOSURE DURING PREGNANCY 403
3.4%
12 PYREXIA 403
3.4%
13 DIZZINESS 393
3.3%
14 MUSCLE SPASMS 352
2.9%
15 ABDOMINAL PAIN 343
2.9%
16 EXPOSURE DURING PREGNANCY 326
2.7%
17 PRODUCT USE IN UNAPPROVED INDICATION 315
2.6%
18 FATIGUE 283
2.4%
19 MENORRHAGIA 262
2.2%
20 DIARRHOEA 244
2.0%
21 MALAISE 227
1.9%
22 DRUG INEFFECTIVE FOR UNAPPROVED INDICATION 218
1.8%
23 FOETAL EXPOSURE DURING DELIVERY 206
1.7%
24 DYSPNOEA 205
1.7%
25 HEADACHE 202
1.7%
26 ASTHENIA 199
1.7%
27 SYNCOPE 178
1.5%
28 DRUG EXPOSURE DURING PREGNANCY 176
1.5%
29 VAGINAL HAEMORRHAGE 174
1.4%
30 RASH 172
1.4%

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.