Dinoprostone side effects: what 799 FDA adverse event reports show
Brand names
Cervidil
Who reports
799 reports · 86% serious · 50 with death outcome · 83% female
Used for
CERVIDIL is indicated for the initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labor. CERVIDIL is a prostaglandin analog indicated for the initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labor.
What it is
CERVIDIL (dinoprostone) vaginal insert contains dinoprostone, a prostaglandin analog. Each vaginal insert contains 10 mg of dinoprostone in 241 mg of a cross-linked polyethylene oxide/urethane.
Boxed warning
None in the current label
Causality screen of the 16 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 4 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Caesarean section | 62 | 139.1 109.4–176.8ROR 150.7 · χ² 8,322 / p <1e-300 | 132.8 EB05 107.3 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 89.1 | no trial data cached |
| Drug exposure during pregnancy | 75 | 57.2 46.1–70.9ROR 63.0 · χ² 4,081 / p <1e-300 | 56.3 EB05 46.4 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 40.8 | no trial data cached |
| Premature delivery | 33 | 54.2 38.8–75.8ROR 56.5 · χ² 1,669 / p <1e-300 | 52.6 EB05 39.2 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 37.1 | no trial data cached |
| Disseminated intravascular coagulation | 29 | 54.0 37.8–77.2ROR 56.0 · χ² 1,454 / p <1e-300 | 52.2 EB05 38.1 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 36.2 · 93% clinician | no trial data cached |
| Foetal exposure during pregnancy | 124 | 40.1 34.1–47.2ROR 47.3 · χ² 4,701 / p <1e-300 | 39.8 EB05 34.3 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious PRR 27.0 · ♀ 38% (drug 83%) | no trial data cached |
| Premature baby | 36 | 31.3 22.8–43.1ROR 32.8 · χ² 1,027 / p 1e-225 | 30.8 EB05 23.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 20.1 | no trial data cached |
| Exposure during pregnancy | 59 | 24.9 19.5–31.9ROR 26.8 · χ² 1,334 / p 3e-292 | 24.7 EB05 19.9 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 23.8 | no trial data cached |
| Maternal exposure during pregnancy | 59 | 17.6 13.7–22.5ROR 18.9 · χ² 908 / p 7e-200 | 17.4 EB05 14.0 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 14.0 | no trial data cached |
| Abortion induced | 5 | 13.9 5.8–33.4ROR 14.0 · χ² 48 / p 2e-12 | 9.5 EB05 3.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Circulatory collapse | 9 | 13.8 7.2–26.5ROR 14.0 · χ² 95 / p 1e-22 | 11.7 EB05 5.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 8 | 13.3 6.7–26.6ROR 13.5 · χ² 79 / p 3e-19 | 10.8 EB05 4.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Contraindicated product administered | 13 | 11.3 6.6–19.4ROR 11.5 · χ² 112 / p 2e-26 | 9.8 EB05 5.5 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 8.7 | no trial data cached |
| Drug withdrawal syndrome neonatal | 6 | 10.5 4.7–23.4ROR 10.6 · χ² 43 / p 3e-11 | 7.2 EB05 3.2 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Vaginal haemorrhage | 17 | 10.5 6.5–16.8ROR 10.7 · χ² 137 / p 7e-32 | 9.3 EB05 5.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.1 | no trial data cached |
| Incorrect product administration duration | 5 | 6.5 2.7–15.5ROR 6.5 · χ² 18 / p 1e-5 | 4.4 EB05 2.0 · IC025 +0.5 3/3 methods agree | Reporting / coding artifact | serious n=5 | no trial data cached |
| Abortion spontaneous | 7 | 4.6 2.2–9.5ROR 4.6 · χ² 16 / p 3e-5 | 3.6 EB05 1.9 · IC025 +0.6 | Labeled (related wording) related wording | serious PRR 3.1 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Foetal exposure during pregnancy | 124 | 40.1 34.1–47.2ROR 47.3 · χ² 4,701 / p <1e-300 | 39.8 EB05 34.3 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious PRR 27.0 · ♀ 38% (drug 83%) | no trial data cached |
| Drug exposure during pregnancy | 75 | 57.2 46.1–70.9ROR 63.0 · χ² 4,081 / p <1e-300 | 56.3 EB05 46.4 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 40.8 | no trial data cached |
| Caesarean section | 62 | 139.1 109.4–176.8ROR 150.7 · χ² 8,322 / p <1e-300 | 132.8 EB05 107.3 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 89.1 | no trial data cached |
| Maternal exposure during pregnancy | 59 | 17.6 13.7–22.5ROR 18.9 · χ² 908 / p 7e-200 | 17.4 EB05 14.0 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 14.0 | no trial data cached |
| Exposure during pregnancy | 59 | 24.9 19.5–31.9ROR 26.8 · χ² 1,334 / p 3e-292 | 24.7 EB05 19.9 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 23.8 | no trial data cached |
| Premature baby | 36 | 31.3 22.8–43.1ROR 32.8 · χ² 1,027 / p 1e-225 | 30.8 EB05 23.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 20.1 | no trial data cached |
| Premature delivery | 33 | 54.2 38.8–75.8ROR 56.5 · χ² 1,669 / p <1e-300 | 52.6 EB05 39.2 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 37.1 | no trial data cached |
| Disseminated intravascular coagulation | 29 | 54.0 37.8–77.2ROR 56.0 · χ² 1,454 / p <1e-300 | 52.2 EB05 38.1 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 36.2 · 93% clinician | no trial data cached |
| Vaginal haemorrhage | 17 | 10.5 6.5–16.8ROR 10.7 · χ² 137 / p 7e-32 | 9.3 EB05 5.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.1 | no trial data cached |
| Contraindicated product administered | 13 | 11.3 6.6–19.4ROR 11.5 · χ² 112 / p 2e-26 | 9.8 EB05 5.5 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 8.7 | no trial data cached |
| Circulatory collapse | 9 | 13.8 7.2–26.5ROR 14.0 · χ² 95 / p 1e-22 | 11.7 EB05 5.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 8 | 13.3 6.7–26.6ROR 13.5 · χ² 79 / p 3e-19 | 10.8 EB05 4.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Abortion spontaneous | 7 | 4.6 2.2–9.5ROR 4.6 · χ² 16 / p 3e-5 | 3.6 EB05 1.9 · IC025 +0.6 | Labeled (related wording) related wording | serious PRR 3.1 | no trial data cached |
| Drug withdrawal syndrome neonatal | 6 | 10.5 4.7–23.4ROR 10.6 · χ² 43 / p 3e-11 | 7.2 EB05 3.2 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Incorrect product administration duration | 5 | 6.5 2.7–15.5ROR 6.5 · χ² 18 / p 1e-5 | 4.4 EB05 2.0 · IC025 +0.5 3/3 methods agree | Reporting / coding artifact | serious n=5 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Caesarean section — n=62, PRR 139.1
- Premature delivery — n=33, PRR 54.2
- Premature baby — n=36, PRR 31.3
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Dinoprostone?
In FDA FAERS, the most frequently co-reported reaction terms for Dinoprostone are caesarean section, premature baby, premature delivery, disseminated intravascular coagulation, vaginal haemorrhage, circulatory collapse. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Dinoprostone have an FDA boxed warning?
No. The FDA label retrieved for Dinoprostone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dinoprostone causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID f3bc9031-0620-4a50-b440-f661cadfeb1d, effective 20230602; matched on
openfda.generic_name.exact:"DINOPROSTONE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 20 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.