Carboprost Tromethamine side effects: what 712 FDA adverse event reports show

Carboprost Tromethamine · 11 reaction terms · 239 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

712 reports · 96% serious · 2 with death outcome · 99% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Carboprost tromethamine injection is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion.

FDA label, Indications and Usage

What it is

DESCRIPTION Carboprost tromethamine injection, USP, an oxytocic, contains the tromethamine salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular injection.

FDA label, Description section

Boxed warning

Carboprost tromethamine, like other potent oxytocic agents, should be used only with strict adherence to recommended dosages. Carboprost tromethamine should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 11 strongest signals

Labeled (related wording) 2Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 7

What the badges mean

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.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
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. 0 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Tachypnoea	23	50.1 33.5–74.9ROR 51.7 · χ² 1,057 / p 4e-232	48.1 EB05 33.8 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 30.9	no trial data cached
Temperature intolerance	10	28.9 15.6–53.4ROR 29.3 · χ² 242 / p 8e-55	27.4 EB05 15.7 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached
Chest discomfort	90	26.0 21.4–31.6ROR 29.6 · χ² 2,148 / p <1e-300	25.9 EB05 21.7 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 23.3	no trial data cached
Bronchospasm (airway tightening)	11	22.6 12.6–40.7ROR 23.0 · χ² 206 / p 4e-47	21.6 EB05 12.4 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 15.0	no trial data cached
Oxygen saturation decreased	29	15.3 10.7–21.9ROR 15.9 · χ² 375 / p 1e-83	15.0 EB05 10.7 · IC025 +3.0 3/3 methods agree	Lab value / disease marker	serious PRR 10.1	no trial data cached
Cold sweat	9	15.0 7.8–28.8ROR 15.2 · χ² 104 / p 9e-25	13.0 EB05 6.1 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 13.6	no trial data cached
Discomfort	29	14.1 9.9–20.1ROR 14.7 · χ² 341 / p 2e-76	13.7 EB05 9.8 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 14.9	no trial data cached
Gastrointestinal pain	5	13.4 5.6–32.2ROR 13.5 · χ² 46 / p 6e-12	9.1 EB05 3.3 · IC025 +1.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.3	no trial data cached
Rash erythematous	21	13.2 8.7–20.1ROR 13.6 · χ² 225 / p 3e-51	12.5 EB05 8.2 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 16.1	no trial data cached
Injection site rash	6	5.8 2.6–12.9ROR 5.9 · χ² 19 / p 5e-6	4.2 EB05 2.1 · IC025 +0.7 3/3 methods agree	Labeled (related wording) related wording	serious n=5	no trial data cached
Incorrect route of drug administration	6	4.9 2.2–10.8ROR 4.9 · χ² 15 / p 6e-5	3.7 EB05 1.9 · IC025 +0.5	Reporting / coding artifact	serious PRR 9.7	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Chest discomfort	90	26.0 21.4–31.6ROR 29.6 · χ² 2,148 / p <1e-300	25.9 EB05 21.7 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 23.3	no trial data cached
Discomfort	29	14.1 9.9–20.1ROR 14.7 · χ² 341 / p 2e-76	13.7 EB05 9.8 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 14.9	no trial data cached
Oxygen saturation decreased	29	15.3 10.7–21.9ROR 15.9 · χ² 375 / p 1e-83	15.0 EB05 10.7 · IC025 +3.0 3/3 methods agree	Lab value / disease marker	serious PRR 10.1	no trial data cached
Tachypnoea	23	50.1 33.5–74.9ROR 51.7 · χ² 1,057 / p 4e-232	48.1 EB05 33.8 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 30.9	no trial data cached
Rash erythematous	21	13.2 8.7–20.1ROR 13.6 · χ² 225 / p 3e-51	12.5 EB05 8.2 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 16.1	no trial data cached
Bronchospasm (airway tightening)	11	22.6 12.6–40.7ROR 23.0 · χ² 206 / p 4e-47	21.6 EB05 12.4 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 15.0	no trial data cached
Temperature intolerance	10	28.9 15.6–53.4ROR 29.3 · χ² 242 / p 8e-55	27.4 EB05 15.7 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached
Cold sweat	9	15.0 7.8–28.8ROR 15.2 · χ² 104 / p 9e-25	13.0 EB05 6.1 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 13.6	no trial data cached
Incorrect route of drug administration	6	4.9 2.2–10.8ROR 4.9 · χ² 15 / p 6e-5	3.7 EB05 1.9 · IC025 +0.5	Reporting / coding artifact	serious PRR 9.7	no trial data cached
Injection site rash	6	5.8 2.6–12.9ROR 5.9 · χ² 19 / p 5e-6	4.2 EB05 2.1 · IC025 +0.7 3/3 methods agree	Labeled (related wording) related wording	serious n=5	no trial data cached
Gastrointestinal pain	5	13.4 5.6–32.2ROR 13.5 · χ² 46 / p 6e-12	9.1 EB05 3.3 · IC025 +1.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.3	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.

Tachypnoea — n=23, PRR 50.1
Chest discomfort — n=90, PRR 26.0
Discomfort — n=29, PRR 14.1
Rash erythematous — n=21, PRR 13.2

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 Carboprost Tromethamine?

In FDA FAERS, the most frequently co-reported reaction terms for Carboprost Tromethamine are chest discomfort, discomfort, oxygen saturation decreased, tachypnoea, rash erythematous, bronchospasm. 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 Carboprost Tromethamine have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: Carboprost tromethamine, like other potent oxytocic agents, should be used only with strict adherence to recommended dosages. Carboprost tromethamine should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities.

Do FAERS signals prove that Carboprost Tromethamine 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 32cb34f5-e199-4cf8-a848-aaec7d42bd10, effective 20251208; matched on openfda.generic_name.exact:"CARBOPROST TROMETHAMINE")
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, field patient.drug.openfda.generic_name.exact, 11 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.