Hemabate Side Effects

Generic name: carboprost

Note: This document contains side effect information about carboprost. Some of the dosage forms listed on this page may not apply to the brand name Hemabate.

Some side effects of Hemabate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to carboprost: injectable solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking carboprost (the active ingredient contained in Hemabate) 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;

• cough;

• headache;

• 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.

For Healthcare Professionals

Applies to carboprost: injectable solution

Gastrointestinal

Pretreatment or concurrent administration of antiemetic and antidiarrheal drugs considerably decreases the very high incidence of gastrointestinal side effects that are common with all prostaglandins used for abortion.

Gastrointestinal side effects including vomiting and diarrhea (67%), nausea (33%), dryness of mouth, hematemesis, taste alterations, epigastric pain, gagging, retching, sensation of choking, dry throat, and fullness of throat have been reported.

Dermatologic

Dermatologic side effects including hot flashes (7%), paresthesia, diaphoresis, and rash have been reported.

Cardiovascular

The degree of hypertension was moderate and it is not certain as to whether it was due to a direct effect of carboprost (the active ingredient contained in Hemabate) or a return to a status of pregnancy associated hypertension manifested by the correction of hypovolemic shock.

Cardiovascular side effects have been reported including an increase in blood pressure (4%) in the postpartum hemorrhage series of clinical studies. Hypertension, tachycardia, and palpitations have also been reported.

Genitourinary

Genitourinary side effects including endometritis, dysmenorrhea-like pain, breast tenderness, vasovagal syndrome, urinary tract infection, posterior cervical perforation, perforated uterus, retained placental fragment, uterine sacculation, excessive uterine bleeding, and uterine rupture have been reported.

When carboprost was used for abortion, the most common complications which required additional treatment after discharge from the hospital were endometritis, retained placental fragments, and excessive uterine bleeding which was reported to have occurred in approximately 2% of patients.

General

Transient pyrexia may be due to the effect of carboprost (the active ingredient contained in Hemabate) on hypothalamic thermoregulation. Temperature elevation exceeding 2 degrees Fahrenheit have been reported in approximately 12.5% of the patients who received the recommended dosage regimen. In all cases, temperature returned to normal when therapy ended.

General side effects have been reported including transient pyrexia, chills, shivering, drowsiness, septic shock, lethargy, sleep disorders, weakness, dizziness, excessive thirst, syncope, chest pain, faintness, and lightheadedness.

Respiratory

Respiratory side effects including hiccough, coughing, asthma, hyperventilation, respiratory distress, pulmonary edema, nosebleed, dyspnea, tightness in chest, wheezing, upper respiratory infection, and shortness of breath have been reported.

Nervous system

Nervous system side effects including headaches have been reported.

Musculoskeletal

Musculoskeletal side effects including backache, dystonia, muscular pain, torticollis, and leg cramps have been reported.

Ocular

Ocular side effects including eye pain, blurred vision, and twitching eyelids have been reported.

Local

Local side effects including injection site pain have been reported.

Other

Other side effects including tinnitus and vertigo have been reported.

Psychiatric

Psychiatric side effects including nervousness and anxiety have been reported.

Endocrine

Endocrine side effects including thyroid storm have been reported.

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