Hemabate Side Effects

Please note - some side effects for Hemabate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Hemabate Side Effects - for the Professional

Hemabate

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:

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.

Side Effects by Body System

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 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 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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.