Carboprost tromethamine

What Carboprost tromethamine is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Carboprost tromethamine injection, USP 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: 1. Failure of expulsion of the fetus during the course of treatment by another method; 2. …

— FDA label: Carboprost Tromethamine, Dr. Reddy's Laboratories Inc., effective March 19, 2025. Read the full label on DailyMed →

Label quoted: the one for the most common form (injection, solution, intramuscular), Carboprost Tromethamine, Dr. Reddy's Laboratories Inc.; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 23 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

8 of 23 FDA labels for this medicine have a boxed warning.

Carboprost tromethamine side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

The adverse effects of carboprost tromethamine 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.

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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). To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy's Laboratories Inc., at 1-888-375-3784, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

— FDA label: Carboprost Tromethamine, Dr. Reddy's Laboratories Inc., effective March 19, 2025. This is part of the section. Read the full label on DailyMed →

Carboprost tromethamine drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

Carboprost tromethamine may augment the activity of other oxytocic agents. Concomitant use with other oxytocic agents is not recommended.

— FDA label: Carboprost Tromethamine, Dr. Reddy's Laboratories Inc., effective March 19, 2025. Read the full label on DailyMed →

Carboprost tromethamine dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

1. Abortion and Indications 1–4 An initial dose of 1 mL of carboprost tromethamine injection sterile solution (containing the equivalent of 250 micrograms of carboprost) is to be administered deep in the muscle. Subsequent doses of 250 micrograms should be administered at 1½ to 3½ hour intervals depending on uterine response. An optional test dose of 100 micrograms (0.4 mL) may be administered initially.

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The dose may be increased to 500 micrograms (2 mL) if uterine contractility is judged to be inadequate after several doses of 250 micrograms (1 mL). The total dose administered of carboprost tromethamine should not exceed 12 milligrams and continuous administration of the drug for more than two days is not recommended. 2. For Refractory Postpartum Uterine Bleeding: An initial dose of 250 micrograms of carboprost tromethamine injection sterile solution (1 mL of carboprost tromethamine injection) is to be given deep, intramuscularly. In clinical trials it was found that the majority of successful cases (73%) responded to single injections. In some selected cases, however, multiple dosing at intervals of 15 to 90 minutes was carried out with successful outcome. The need for additional injections and the interval at which these should be given can be determined only by the attending physicians as dictated by the course of clinical events. The total dose of carboprost tromethamine injection should not exceed 2 milligrams (8 doses). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 1. Abortion and Indications 1–4 An initial dose of 1 mL of carboprost tromethamine injection sterile solution (containing the equivalent of 250 micrograms of carboprost) is to be administered deep in the muscle. Subsequent doses of 250 micrograms should be administered at 1½ to 3½ hour intervals depending on uterine response. An optional test dose of 100 micrograms (0.4 mL) may be administered initially. The dose may be increased to 500 micrograms (2 mL) if uterine contractility is judged to be inadequate after several doses of 250 micrograms (1 mL). The total dose administered of carboprost tromethamine should not exceed 12 milligrams and continuous administration of the drug for more than two days is not recommended. 2. For Refractory Postpartum Uterine Bleeding: An initial dose of 250 micrograms of carboprost tromethamine injection sterile solution (1 mL of carboprost tromethamine injection) is to be given deep, intramuscularly. In clinical trials it was found that the majority of successful cases (73%) responded to single injections. In some selected cases, however, multiple dosing at intervals of 15 to 90 minutes was carried out with successful outcome. The need for additional injections and the interval at which these should be given can be determined only by the attending physicians as dictated by the course of clinical events. The total dose of carboprost tromethamine injection should not exceed 2 milligrams (8 doses).

— FDA label: Carboprost Tromethamine, Dr. Reddy's Laboratories Inc., effective March 19, 2025. This is part of the section. Read the full label on DailyMed →

Carboprost tromethamine in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Teratogenic Effects: Animal studies do not indicate that carboprost tromethamine is teratogenic, however, it has been shown to be embryotoxic in rats and rabbits and any dose which produces increased uterine tone could put the embryo or fetus at risk.

— FDA label: Carboprost Tromethamine, Dr. Reddy's Laboratories Inc., effective March 19, 2025. Read the full label on DailyMed →

When Carboprost tromethamine should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

1. Hypersensitivity (including anaphylaxis and angioedema) to carboprost tromethamine injection sterile solution [see ADVERSE REACTIONS, Post-marketing Experience] 2. Acute pelvic inflammatory disease 3. Patients with active cardiac, pulmonary, renal or hepatic disease WARNINGS Carboprost tromethamine injection sterile solution (carboprost tromethamine), like other potent oxytocic agents, should be used only with strict adherence to recommended dosages.

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Carboprost tromethamine injection should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities Carboprost tromethamine does not appear to directly affect the fetoplacental unit. Therefore, the possibility does exist that the previable fetus aborted by carboprost tromethamine could exhibit transient life signs. Carboprost tromethamine is not indicated if the fetus in utero has reached the stage of viability. Carboprost tromethamine injection should not be considered a feticidal agent. Evidence from animal studies has suggested that certain other prostaglandins have some teratogenic potential. Although these studies do not indicate that carboprost tromethamine injection is teratogenic, any pregnancy termination with carboprost tromethamine injection that fails should be completed by some other means. This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.

— FDA label: Carboprost Tromethamine, Dr. Reddy's Laboratories Inc., effective March 19, 2025. Read the full label on DailyMed →

Forms and how it is given

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Dr.Reddys Laboratories Inc2 products
• Dr. Reddy's Laboratories Inc.2 products
• Onesource Specialty Pharma Limited1 product
• Micro Labs Limited1 product
• Alembic Pharmaceuticals Inc.1 product
• Somerset Therapeutics, LLC1 product
• Hikma Pharmaceuticals USA Inc.1 product
• Eugia US LLC1 product
• ANI Pharmaceuticals, Inc.1 product
• BE Pharmaceuticals Inc.1 product
• Armas Pharmaceuticals Inc.1 product
• Alembic Pharmaceuticals Limited1 product
• Amneal Pharmaceuticals LLC1 product
• Hospira, Inc.1 product
• Fresenius Kabi USA, LLC1 product
• Caplin Steriles Limited1 product
• Gland Pharma Limited1 product
• Sagent Pharmaceuticals1 product
• Pharmacia & Upjohn Company LLC1 product
• Omnivium Pharmaceuticals LLC.1 product
• SOLA Pharmaceuticals, LLC1 product
• Long Grove Pharmaceuticals, LLC1 product
• Xellia Pharmaceuticals USA LLC1 product

FDA approval history

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (13)

• ANDA211941DR Reddys · July 2, 2019
• ANDA213118Sunny · March 25, 2021
• ANDA215337Amneal · January 27, 2022
• ANDA214499Long Grove Pharms · August 9, 2022
• ANDA216882Caplin · February 13, 2023
• ANDA216824Sola Pharms · May 19, 2023
• ANDA216939Eugia Pharma · May 25, 2023
• ANDA217198Alembic · June 15, 2023
• ANDA216897Onesource Specialty · July 25, 2023
• ANDA217657Gland · August 7, 2023
• ANDA215901Ani Pharms · January 25, 2024
• ANDA218013Micro Labs · April 3, 2024
• ANDA219529Somerset Theraps LLC · May 27, 2026

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

Next steps

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• HemabateBrand page: products, maker and price
• Dr.Reddys Laboratories IncMaker or distributor
• Dr. Reddy's Laboratories Inc.Maker or distributor
• Onesource Specialty Pharma LimitedMaker or distributor
• All prescription drugs A to ZSearch by generic, brand or Spanish name

Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Carboprost Tromethamine, Dr. Reddy's Laboratories Inc., effective March 19, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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