ADVERSE REACTIONS
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 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 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).