carboprost tromethamine

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
carboprost tromethamine
Generic name
CARBOPROST TROMETHAMINE
Manufacturer
Amneal Pharmaceuticals LLC
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
eac3fd1c-ca4b-4aa3-9dc2-e7dbeb4c122a
SPL ID
ec46a8fb-b01e-4e93-950a-a3c34203e351
Version
6
Effective date
2025-10-31
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:15:49
Harmonized routes table
Harmonized routes
INTRAMUSCULAR

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 2 matching rows.

adverse reactions

ADVERSE REACTIONS The adverse effects of carboprost tromethamine injection are generally transient and reversible when therapy ends. The most frequent adverse reactions observed are related to its contractile effect on smooth muscle. In patients studied, approximately two-thirds experienced vomiting and diarrhea, approximately one-third had nausea, one-eighth had a temperature increase greater than 2°F, and one-fourteenth experienced flushing. The pretreatment or concurrent administration of antiemetic and antidiarrheal drugs decreases considerably the very high incidence of gastrointestinal effects common with all prostaglandins used for abortion. Their use should be considered an integral part of the management of patients undergoing abortion with carboprost tromethamine. Of those patients experiencing a temperature elevation, approximately one-sixteenth had a clinical diagnosis of endometritis. The remaining temperature elevations returned to normal within several hours after the last injection. Adverse effects observed during the use of carboprost tromethamine for abortion and for hemorrhage, not all of which are clearly drug related, in decreasing order of frequency include: Vomiting Nervousness Diarrhea Nosebleed Nausea Sleep disorders Flushing or hot flashes Dyspnea Chills or shivering Tightness in chest Coughing Wheezing Headaches Posterior cervical perforation Endometritis Weakness Hiccough Diaphoresis Dysmenorrhea-like pain Dizziness Paresthesia Blurred vision Backache Epigastric pain Muscular pain Excessive thirst Breast tenderness Twitching eyelids Eye pain Gagging, retching Drowsiness Dry throat Dystonia Sensation of choking Asthma Thyroid storm Injection site pain Syncope Tinnitus Palpitations Vertigo Rash Vaso-vagal syndrome Upper respiratory infection Dryness of mouth Leg cramps Hyperventilation Perforated uterus Respiratory distress Anxiety Hematemesis Chest pain Taste alterations Retained placental fragment Urinary tract infection Shortness of breath Septic shock Fullness of throat Torticollis Uterine sacculation Lethargy Faintness, light-headedness Hypertension Uterine rupture Tachycardia Pulmonary edema Endometritis from IUCD The most common complications when carboprost tromethamine was utilized for abortion requiring additional treatment after discharge from the hospital were endometritis, retained placental fragments, and excessive uterine bleeding, occurring in about one in every 50 patients. Post-marketing experience: Hypersensitivity reactions (e.g. anaphylactic reaction, anaphylactic shock, anaphylactoid reaction, angioedema).

adverse reactions table

<table width="100%" cellspacing="0" cellpadding="0" border="1"><col width="17pt"/><col width="17pt"/><tbody><tr><td><paragraph>Vomiting</paragraph></td><td><paragraph>Nervousness</paragraph></td></tr><tr><td><paragraph>Diarrhea</paragraph></td><td><paragraph>Nosebleed</paragraph></td></tr><tr><td><paragraph>Nausea</paragraph></td><td><paragraph>Sleep disorders</paragraph></td></tr><tr><td><paragraph>Flushing or hot flashes</paragraph></td><td><paragraph>Dyspnea</paragraph></td></tr><tr><td><paragraph>Chills or shivering</paragraph></td><td><paragraph>Tightness in chest</paragraph></td></tr><tr><td><paragraph>Coughing</paragraph></td><td><paragraph>Wheezing</paragraph></td></tr><tr><td><paragraph>Headaches</paragraph></td><td><paragraph>Posterior cervical perforation</paragraph></td></tr><tr><td><paragraph>Endometritis</paragraph></td><td><paragraph>Weakness</paragraph></td></tr><tr><td><paragraph>Hiccough</paragraph></td><td><paragraph>Diaphoresis</paragraph></td></tr><tr><td><paragraph>Dysmenorrhea-like pain</paragraph></td><td><paragraph>Dizziness</paragraph></td></tr><tr><td><paragraph>Paresthesia</paragraph></td><td><paragraph>Blurred vision</paragraph></td></tr><tr><td><paragraph>Backache</paragraph></td><td><paragraph>Epigastric pain</paragraph></td></tr><tr><td><paragraph>Muscular pain</paragraph></td><td><paragraph>Excessive thirst</paragraph></td></tr><tr><td><paragraph>Breast tenderness</paragraph></td><td><paragraph>Twitching eyelids</paragraph></td></tr><tr><td><paragraph>Eye pain</paragraph></td><td><paragraph>Gagging, retching</paragraph></td></tr><tr><td><paragraph>Drowsiness</paragraph></td><td><paragraph>Dry throat</paragraph></td></tr><tr><td><paragraph>Dystonia</paragraph></td><td><paragraph>Sensation of choking</paragraph></td></tr><tr><td><paragraph>Asthma</paragraph></td><td><paragraph>Thyroid storm</paragraph></td></tr><tr><td><paragraph>Injection site pain</paragraph></td><td><paragraph>Syncope</paragraph></td></tr><tr><td><paragraph>Tinnitus</paragraph></td><td><paragraph>Palpitations</paragraph></td></tr><tr><td><paragraph>Vertigo</paragraph></td><td><paragraph>Rash</paragraph></td></tr><tr><td><paragraph>Vaso-vagal syndrome</paragraph></td><td><paragraph>Upper respiratory infection</paragraph></td></tr><tr><td><paragraph>Dryness of mouth</paragraph></td><td><paragraph>Leg cramps</paragraph></td></tr><tr><td><paragraph>Hyperventilation</paragraph></td><td><paragraph>Perforated uterus</paragraph></td></tr><tr><td><paragraph>Respiratory distress</paragraph></td><td><paragraph>Anxiety</paragraph></td></tr><tr><td><paragraph>Hematemesis</paragraph></td><td><paragraph>Chest pain</paragraph></td></tr><tr><td><paragraph>Taste alterations</paragraph></td><td><paragraph>Retained placental fragment</paragraph></td></tr><tr><td><paragraph>Urinary tract infection</paragraph></td><td><paragraph>Shortness of breath</paragraph></td></tr><tr><td><paragraph>Septic shock</paragraph></td><td><paragraph>Fullness of throat</paragraph></td></tr><tr><td><paragraph>Torticollis</paragraph></td><td><paragraph>Uterine sacculation</paragraph></td></tr><tr><td><paragraph>Lethargy</paragraph></td><td><paragraph>Faintness, light-headedness</paragraph></td></tr><tr><td><paragraph>Hypertension</paragraph></td><td><paragraph>Uterine rupture</paragraph></td></tr><tr><td><paragraph>Tachycardia</paragraph></td><td/></tr><tr><td><paragraph>Pulmonary edema</paragraph></td><td/></tr><tr><td><paragraph>Endometritis from IUCD</paragraph></td><td/></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.