OpenClaim

Dinoprostone Side Effects

The most commonly reported side effects of dinoprostone include drug exposure during pregnancy, foetal exposure during pregnancy, and caesarean section, based on 1,091 FDA adverse event reports from 2004 to 2025. 3.9% of reports found the drug to be ineffective.

Dinoprostone side effects

Percentages show how often each reaction appears relative to total reports for dinoprostone.

1
Drug Exposure During Pregnancy13.0%142
2
Foetal Exposure During Pregnancy12.6%138
3
Caesarean Section10.4%114
4
Maternal Exposure During Pregnancy7.0%76
5
Exposure During Pregnancy6.3%69
6
Off Label Use4.8%52
7
Uterine Hyperstimulation4.8%52
8
Maternal Drugs Affecting Foetus4.0%44
9
Drug Ineffective3.9%43
10
Premature Baby3.9%43
11
Small For Dates Baby3.7%40
12
Premature Separation Of Placenta3.5%38
13
Premature Delivery3.3%36
14
Foetal Heart Rate Deceleration Abnormality3.2%35
15
Uterine Hypertonus2.9%32

These are voluntary reports and do not establish that dinoprostone caused these reactions.

Report severity

88.8%Serious969 reports
24.9%Hospitalizations272 reports
8.0%Fatal87 reports

Seriousness is determined by the reporter, not by OpenClaim.

Dinoprostone drug interactions

Other drugs that appear in adverse event reports alongside dinoprostone. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Oxytocin12.5%136
2
Betamethasone5.5%60
3
Cefuroxime4.9%53
4
Metronidazole4.8%52
5
Cytarabine4.4%48
6
Amphotericin-b4.4%48
7
Daunorubicin4.4%48
8
Meropenem4.3%47
9
Quetiapine-fumarate4.0%44
10
Magnesium-acetate-tetrahydrate3.5%38
11
Venlafaxine3.1%34
12
Fentanyl2.7%29
13
Ferrous-sulfate2.4%26
14
Pantoprazole-sodium1.6%17
15
Prednisolone1.5%16

Taken alongside

1
Oxytocin8.2%89
2
Acetaminophen2.8%31
3
Misoprostol2.4%26
4
Aspirin1.9%21
5
Levothyroxine-sodium1.8%20
6
Folic-acid1.5%16
7
Albuterol1.5%16
8
Methyldopa1.3%14
9
Ondansetron1.3%14
10
Labetalol-hydrochloride1.2%13
11
Insulin1.2%13
12
Amoxicillin1.2%13
13
Sodium-chloride1.1%12
14
Enoxaparin-sodium0.9%10
15
Bupivacaine0.9%10

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports dinoprostone side effects

58.7% of dinoprostone adverse event reports involve female patients and 10.1% involve male patients. The largest age group is adult at 74%. These figures reflect who reports side effects, not underlying risk.

Sex

Female58.7%
Male10.1%
Unknown31.3%

Age group

< 222.7%
2–110.4%
12–172.0%
18–6473.8%
65+1.0%

What is dinoprostone used for

Conditions and purposes for which patients were taking dinoprostone when the adverse event was reported.

Aborted PregnancyAbortion InducedArthropathyBlood PressureBishop ScoreCervix DisorderComplication Of DeliveryCongenital Tricuspid Valve AtresiaCervical DilatationDelayed DeliveryDeliveryDrug Use For Unknown IndicationDeliveryDermatitis AtopicEbstein's Anomaly

Showing 15 of 63 indications

Dinoprostone brand names and reporting trend

Dinoprostone is sold under the brand name Prepidil.

Brand names

Prepidil566

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking dinoprostone with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.