Prostin E2 Adverse Reactions

Maternal Adverse Events: The following maternal adverse events have been reported with use of vaginal tablets: Immune system disorders: Hypersensitivity reactions (e.g., Anaphylactic reaction, Anaphylactic shock, Anaphylactoid reaction).
Gastrointestinal disorders: Diarrhea, nausea, vomiting.
Musculoskeletal and connective tissue disorders: Back pain.
Pregnancy, puerperium and perinatal conditions: Uterine contractile abnormalities (increase frequency, tone, or duration), uterine rupture, abruptio placenta, pulmonary amniotic fluid embolism, rapid cervical dilatation.
Reproductive system and breast disorders: Warm feeling in vagina.
General disorders and administration site conditions: Fever.
Vascular disorders: Hypertension.
Respiratory, thoracic and mediastinal disorders: Asthma, bronchospasm.
Fetal Adverse Events: The following fetal adverse events have been reported with use of vaginal tablets: Pregnancy, puerperium and perinatal conditions: Foetal death, Still births, Neonatal death.
Investigations: Fetal distress/altered fetal heart rate (FHR), neonatal distress/low Apgar score.
Foetal death, stillbirth, and neonatal death have been reported after application of dinoprostone, especially following the occurrence of serious events such as uterine rupture (see Dosage & Administration, Contraindications and Precautions).
Post-marketing surveillance: Blood and lymphatic system disorders: An increased risk of post-partum disseminated intravascular coagulation has been described in patients whose labor was induced by pharmacological means, either with dinoprostone or oxytocin (see Precautions). The frequency of this adverse event, however, appears to be rare (<1 per 1,000 labors).