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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:

Vomiting Nervousness
Diarrhea Nosebleed
Nausea Sleep disorders
Flushing or hot flashes Dyspnea
Chills or shivering Tightness in chest
Coughing Wheezing
Headaches Posterior cervical
Endometritis perforation
Hiccough Weakness
Dysmenorrhea-like Diaphoresis
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
Dryness of mouth infection
Hyperventilation Leg cramps
Respiratory distress Perforated uterus
Hematemesis Anxiety
Taste alterations Chest pain
Urinary tract infection Retained placental
Septic shock fragment
Torticollis Shortness of breath
Lethargy Fullness of throat
Hypertension Uterine sacculation
Tachycardia Faintness, light-
Pulmonary edema headedness
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.

Post-marketing experience

Hypersensitivity reactions (e.g. Anaphylactic reaction, Anaphylactic shock, Anaphylactoid reaction, Angioedema).