MISOPROSTOL

N/A

Manufactured by Pfizer Laboratories Div Pfizer Inc

18,857 FDA adverse event reports analyzed

Last updated: 2026-04-14

About MISOPROSTOL

MISOPROSTOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. The most commonly reported adverse reactions for MISOPROSTOL include HAEMORRHAGE, ABORTION INCOMPLETE, OFF LABEL USE, FOETAL EXPOSURE DURING PREGNANCY, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MISOPROSTOL.

Top Adverse Reactions

HAEMORRHAGE1,258 reports
ABORTION INCOMPLETE1,159 reports
OFF LABEL USE897 reports
FOETAL EXPOSURE DURING PREGNANCY625 reports
PAIN536 reports
ANAEMIA511 reports
PREGNANCY448 reports
NAUSEA434 reports
DRUG INEFFECTIVE425 reports
VOMITING416 reports
PYREXIA402 reports
MATERNAL EXPOSURE DURING PREGNANCY397 reports
DIZZINESS389 reports
MUSCLE SPASMS352 reports
ABDOMINAL PAIN335 reports
EXPOSURE DURING PREGNANCY318 reports
PRODUCT USE IN UNAPPROVED INDICATION315 reports
FATIGUE280 reports
MENORRHAGIA262 reports
DIARRHOEA242 reports
MALAISE223 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION214 reports
FOETAL EXPOSURE DURING DELIVERY206 reports
HEADACHE204 reports
DYSPNOEA199 reports
ASTHENIA197 reports
SYNCOPE178 reports
DRUG EXPOSURE DURING PREGNANCY177 reports
PNEUMONIA171 reports
VAGINAL HAEMORRHAGE171 reports
RASH170 reports
ARTHRALGIA167 reports
INFECTION167 reports
DRUG HYPERSENSITIVITY166 reports
CHILLS160 reports
ENDOMETRITIS157 reports
CONDITION AGGRAVATED153 reports
PAIN IN EXTREMITY152 reports
HYPOAESTHESIA144 reports
PRURITUS142 reports
RHEUMATOID ARTHRITIS136 reports
PREMATURE BABY129 reports
HYPOTENSION125 reports
HYPERTENSION124 reports
PRODUCT USE ISSUE123 reports
ANXIETY119 reports
DRUG INTOLERANCE118 reports
ABORTION INDUCED116 reports
FALL116 reports
UTERINE RUPTURE110 reports
TREMOR107 reports
BACK PAIN104 reports
UTERINE TACHYSYSTOLE104 reports
DEATH103 reports
TACHYCARDIA102 reports
LOSS OF CONSCIOUSNESS101 reports
FOETAL HEART RATE DECREASED99 reports
HAEMOGLOBIN DECREASED99 reports
COMPLICATION OF DEVICE INSERTION97 reports
VENTRICULAR SEPTAL DEFECT97 reports
INSOMNIA95 reports
FOETAL DEATH94 reports
SEPSIS91 reports
SMALL FOR DATES BABY91 reports
DEPRESSION90 reports
CONSTIPATION88 reports
DRUG INTERACTION88 reports
URINARY TRACT INFECTION88 reports
INTERSTITIAL LUNG DISEASE87 reports
CHEST PAIN85 reports
COUGH85 reports
STAPHYLOCOCCAL INFECTION85 reports
WEIGHT DECREASED85 reports
FOETAL DISTRESS SYNDROME82 reports
PELVIC PAIN82 reports
PROCEDURAL PAIN82 reports
CARDIAC ARREST79 reports
OEDEMA PERIPHERAL79 reports
ABDOMINAL PAIN UPPER76 reports
ABDOMINAL DISCOMFORT75 reports
HYPERSENSITIVITY75 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE74 reports
GASTROOESOPHAGEAL REFLUX DISEASE73 reports
GESTATIONAL DIABETES73 reports
INDUCED ABORTION FAILED72 reports
STILLBIRTH72 reports
LYME DISEASE71 reports
UTERINE HAEMORRHAGE71 reports
ATRIAL SEPTAL DEFECT70 reports
DECREASED APPETITE70 reports
GAIT DISTURBANCE70 reports
BLOODY DISCHARGE69 reports
INJURY69 reports
INTERNATIONAL NORMALISED RATIO FLUCTUATION69 reports
PLEURAL EFFUSION69 reports
ANAPHYLACTIC REACTION68 reports
PLATELET COUNT DECREASED68 reports
RED BLOOD CELL SEDIMENTATION RATE INCREASED68 reports
DEHYDRATION66 reports
POSTPARTUM HAEMORRHAGE65 reports

Report Outcomes

Out of 9,541 classified reports for MISOPROSTOL:

Serious 68.8%Non-Serious 31.2%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female7,476 (84.2%)
Male1,362 (15.3%)
Unknown44 (0.5%)

Reports by Age

Age 22251 reports
Age 24248 reports
Age 27248 reports
Age 23247 reports
Age 28246 reports
Age 29242 reports
Age 21231 reports
Age 25230 reports
Age 32229 reports
Age 26211 reports
Age 33208 reports
Age 30207 reports
Age 20197 reports
Age 34194 reports
Age 1185 reports
Age 35173 reports
Age 19170 reports
Age 31169 reports
Age 37169 reports
Age 36144 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with MISOPROSTOL?

This profile reflects 18,857 FDA FAERS reports that mention MISOPROSTOL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for MISOPROSTOL?

Frequently reported terms in FAERS include HAEMORRHAGE, ABORTION INCOMPLETE, OFF LABEL USE, FOETAL EXPOSURE DURING PREGNANCY, PAIN, ANAEMIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures MISOPROSTOL?

Labeling and FAERS entries often list Pfizer Laboratories Div Pfizer Inc in connection with MISOPROSTOL. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.