Home FDA labels ed3dacb6-5a1e-4499-bec2-5ec46a0399ad carboprost tromethamine openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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Brand name carboprost tromethamine
Generic name CARBOPROST TROMETHAMINE
Manufacturer Gland Pharma Limited
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 5902edd8-16b3-4f52-ac35-b0f4dfb5ab6a
SPL ID ed3dacb6-5a1e-4499-bec2-5ec46a0399ad
Version 2
Effective date 2023-08-08
Source export date 2026-09-28
Source partition 3
Source file https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 05:17:49 Harmonized routes table Harmonized routes INTRAMUSCULAR
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adverse reactions ADVERSE REACTIONS The adverse effects of Carboprost Tromethamine Injection Sterile Solution 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 Injection 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 Injection 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 cellspacing="0" cellpadding="0" border="0" width="779.38"><colgroup><col width="46.7576791808874%"/><col width="53.2423208191126%"/></colgroup><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Vomiting </td><td styleCode="Rrule" align="justify" valign="top">Nervousness </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Diarrhea </td><td styleCode="Rrule" align="justify" valign="top">Nosebleed </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Nausea </td><td styleCode="Rrule" align="justify" valign="top">Sleep disorders </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Flushing or hot flashes </td><td styleCode="Rrule" align="justify" valign="top">Dyspnea </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Chills or shivering </td><td styleCode="Rrule" align="justify" valign="top">Tightness in chest </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Coughing </td><td styleCode="Rrule" align="justify" valign="top">Wheezing </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Headaches </td><td styleCode="Rrule" align="justify" valign="top">Posterior cervical perforation </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Endometritis </td><td styleCode="Rrule" align="justify" valign="top">Weakness </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Hiccough </td><td styleCode="Rrule" align="justify" valign="top">Diaphoresis </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Dysmenorrhea-like pain </td><td styleCode="Rrule" align="justify" valign="top">Dizziness </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Paresthesia </td><td styleCode="Rrule" align="justify" valign="top">Blurred vision </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Backache </td><td styleCode="Rrule" align="justify" valign="top">Epigastric pain </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Muscular pain </td><td styleCode="Rrule" align="justify" valign="top">Excessive thirst </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Breast tenderness </td><td styleCode="Rrule" align="justify" valign="top">Twitching eyelids </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Eye pain </td><td styleCode="Rrule" align="justify" valign="top">Gagging, retching </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Drowsiness </td><td styleCode="Rrule" align="justify" valign="top">Dry throat </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Dystonia </td><td styleCode="Rrule" align="justify" valign="top">Sensation of choking </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Asthma </td><td styleCode="Rrule" align="justify" valign="top">Thyroid storm </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Injection site pain </td><td styleCode="Rrule" align="justify" valign="top">Syncope </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Tinnitus </td><td styleCode="Rrule" align="justify" valign="top">Palpitations </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Vertigo </td><td styleCode="Rrule" align="justify" valign="top">Rash </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Vaso-vagal syndrome </td><td styleCode="Rrule" align="justify" valign="top">Upper respiratory infection </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Dryness of mouth </td><td styleCode="Rrule" align="justify" valign="top">Leg cramps </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Hyperventilation </td><td styleCode="Rrule" align="justify" valign="top">Perforated uterus </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Respiratory distress </td><td styleCode="Rrule" align="justify" valign="top">Anxiety </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Hematemesis </td><td styleCode="Rrule" align="justify" valign="top">Chest pain </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Taste alterations </td><td styleCode="Rrule" align="justify" valign="top">Retained placental fragment </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Urinary tract infection </td><td styleCode="Rrule" align="justify" valign="top">Shortness of breath </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Septic shock </td><td styleCode="Rrule" align="justify" valign="top">Fullness of throat </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Torticollis </td><td styleCode="Rrule" align="justify" valign="top">Uterine sacculation </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Lethargy </td><td styleCode="Rrule" align="justify" valign="top">Faintness, light-headedness </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Hypertension </td><td styleCode="Rrule" align="justify" valign="top">Uterine rupture </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Tachycardia </td><td styleCode="Rrule" align="justify" valign="top"> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top">Pulmonary edema </td><td styleCode="Rrule" align="justify" valign="top"> </td></tr><tr><td styleCode="Lrule Rrule" align="justify" valign="top">Endometritis from IUCD </td><td styleCode="Rrule" align="justify" valign="top"> </td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.