"In a drug safety communication issued today, the US Food and Drug Administration (FDA) says it is aware of recent reports "questioning" the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy, but that it l"...
Hemabate Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Hemabate (carboprost tromethamine) Sterile Solution is a form of prostaglandin (a hormone-like substance that occurs naturally in the body) used to treat severe bleeding after childbirth (postpartum). Hemabate is also used to produce an abortion by causing uterine contractions. It is usually given between the 13th and 20th weeks of pregnancy, but may be given at other times for medical reasons. Hemabate is often used when another method of abortion has not completely emptied the uterus, or when a complication of pregnancy would cause the baby to be born too early to survive. Common side effects of Hemabate include mild fever that may come and go, chills, numbness, tingly feeling, nausea, diarrhea, cough, headache, breast pain or tenderness, menstrual type pain, or ringing in your ears.
To treat refractory postpartum uterine bleeding, an initial dose of 250 mcg of Hemabate Sterile Solution (1 mL) is given deep, intramuscularly. For abortion and other indications, an initial dose of 1 mL (250 mcg) is administered deep in the muscle. Subsequent doses of 250 mcg are administered at 1½ to 3½ hour intervals depending on uterine response. Hemabate may interact with dinoprostone, mifepristone, misoprostol, or oxytocin. Tell your doctor all medications you are taking. During pregnancy, Hemabate should be used only if prescribed. There is no information on this medication and whether it passes into breast milk. Consult your doctor before breast-feeding.
Our Hemabate (carboprost tromethamine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Hemabate in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- severe pelvic pain, cramping, or vaginal bleeding;
- high fever;
- feeling light-headed or short of breath;
- severe nausea, vomiting, or diarrhea; or
- increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).
Less serious side effects include:
- mild fever that may come and go;
- chills, numbness, or tingly feeling;
- mild nausea or diarrhea;
- breast pain or tenderness;
- menstrual type pain; or
- ringing in your ears.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Hemabate (Carboprost Tromethamine)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Hemabate FDA Prescribing Information: Side Effects
The adverse effects of HEMABATE 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 HEMABATE.
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 HEMABATE for abortion and for hemorrhage, not all of which are clearly drug related, in decreasing order of frequency include:
|Flushing or hot flashes||Dyspnea|
|Chills or shivering||Tightness in chest|
|Muscular pain||Excessive thirst|
|Breast tenderness||Twitching eyelids|
|Eye pain||Gagging, retching|
|Dystonia||Sensation of choking|
|Injection site pain||Syncope|
|Vaso-vagal syndrome||Upper respiratory|
|Dryness of mouth||infection|
|Respiratory distress||Perforated uterus|
|Taste alterations||Chest pain|
|Urinary tract infection||Retained placental|
|Torticollis||Shortness of breath|
|Lethargy||Fullness of throat|
|Endometritis from IUCD||Uterine rupture|
The most common complications when HEMABATE 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.
Read the entire FDA prescribing information for Hemabate (Carboprost Tromethamine)
Additional Hemabate Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Parenting and Pregnancy
Get tips for baby and you.