This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Cervidil (Dinoprostone Vaginal) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (8)
Life Threatening Events (2)
Reports by Reaction Type
Caesarean Section (4),
Maternal Exposure During Pregnancy (4),
Foetal Heart Rate Deceleration (3),
Premature Separation of Placenta (3),
Maternal Drugs Affecting Foetus (2),
Foetal Distress Syndrome (2),
Bradycardia Foetal (2),
Product Quality Issue (2),
Uterine Hypertonus (2),
Hypertension (2),
Foetal Exposure During Pregnancy (1),
Electroencephalogram Abnormal (1)
Possible Cervidil side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-03
Patient: female, weighing 50.8 kg (111.9 pounds)
Reactions: Off Label Use, Premature Separation of Placenta, Gestational Diabetes, Hypertension, Postpartum Depression
Drug(s) suspected as cause:
Cervidil
Indication: Induced Labour
Start date: 2011-10-14
End date: 2011-10-14
Humira
Indication: Colitis Ulcerative
Start date: 2007-01-01
End date: 2011-02-01
Other drugs received by patient: Lovenox; Multi-Vitamins
Possible Cervidil side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-03
Patient: male
Reactions: Ultrasound Scan Abnormal, Exposure During Breast Feeding, Foetal Heart Rate Deceleration, Foetal Exposure During Pregnancy, Neonatal Respiratory Arrest
Drug(s) suspected as cause:
Cervidil
Indication: Maternal Exposure Timing Unspecified
Humira
Indication: Maternal Exposure Timing Unspecified
Humira
Possible Cervidil side effects in 35 year old female
Reported by a pharmacist from United States on 2012-03-15
Patient: 35 year old female, weighing 84.0 kg (184.8 pounds)
Reactions: Hysterectomy, Drug Effect Decreased, Maternal Exposure During Pregnancy, Hypotension, Uterine Rupture
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Cervidil
Possible Cervidil side effects in 33 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-14
Patient: 33 year old female
Reactions: Product Quality Issue, Caesarean Section, Premature Separation of Placenta, Maternal Exposure During Pregnancy
Drug(s) suspected as cause:
Cervidil
Possible Cervidil side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-14
Patient: female
Reactions: Product Quality Issue, Uterine Hypertonus, Foetal Heart Rate Deceleration, Maternal Exposure During Pregnancy
Drug(s) suspected as cause:
Cervidil
Possible Cervidil side effects in 33 year old female
Reported by a physician from United States on 2011-12-27
Patient: 33 year old female, weighing 72.5 kg (159.5 pounds)
Reactions: Caesarean Section, Maternal Drugs Affecting Foetus, Foetal Heart Rate Deceleration, Uterine Contractions Abnormal, Premature Separation of Placenta
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Cervidil
Possible Cervidil side effects in 36 year old female
Reported by a pharmacist from United Kingdom on 2011-10-11
Patient: 36 year old female, weighing 61.0 kg (134.2 pounds)
Reactions: Defaecation Urgency, Uterine Hypertonus, Maternal Exposure During Pregnancy, Abdominal Discomfort, Bradycardia Foetal, Foetal Distress Syndrome, Gastrointestinal Pain, Caesarean Section, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cervidil
Other drugs received by patient: Human Protaphane (Insulin Human Injection, Isophane) (Injection) (Insu; Novolog; Fefol (Folic Acid)
Possible Cervidil side effects in female
Reported by a pharmacist from United Kingdom on 2011-10-11
Patient: female, weighing 3.8 kg (8.3 pounds)
Reactions: Maternal Drugs Affecting Foetus, Apgar Score LOW, Convulsion Neonatal, Foetal Distress Syndrome, Electroencephalogram Abnormal, Bradycardia Foetal, Hypoxic-Ischaemic Encephalopathy, Caesarean Section, Thalamic Infarction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cervidil
Other drugs received by patient: Novorapid (Insuloin Aspart); Fefol (Folic Acid); Human Protaphane (Insuloin Human Injection, Isophane)
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