Index of reports
> Cases with Off Label Use (11)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Cytotec (Misoprostol) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Cytotec side effects in 32 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-27
Patient: 32 year old female
Reactions: Uterine Hypertonus, Off Label Use, Abdominal Pain, Pyrexia, Sinus Tachycardia, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cytotec
Other drugs received by patient: Atarax; Nimbex; Lidocaine; Mifegyne; Sufentanil
Possible Cytotec side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-27
Patient: female
Reactions: Off Label Use, Diarrhoea, Vaginal Haemorrhage
Drug(s) suspected as cause:
Cytotec
Possible Cytotec side effects in female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-07-23
Patient: female
Reactions: Off Label Use, Premature Separation of Placenta, Uterine Haemorrhage
Drug(s) suspected as cause:
Cytotec
Possible Cytotec side effects in 32 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-23
Patient: 32 year old female
Reactions: Off Label Use, Uterine Hypertonus, Abdominal Pain, Pyrexia, Hypertension, Sinus Tachycardia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cytotec
Other drugs received by patient: Mifegyne; Nimbex; Sufentanil; Atarax; Lidocaine
Possible Cytotec side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-19
Patient: female
Reactions: Off Label Use, Diarrhoea, Vaginal Haemorrhage
Drug(s) suspected as cause:
Cytotec
Possible Cytotec side effects in female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-07-18
Patient: female
Reactions: Off Label Use, Haemorrhage, Premature Separation of Placenta
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cytotec
Possible Cytotec side effects in 28 year old female
Reported by a physician from Sweden on 2012-07-16
Patient: 28 year old female
Reactions: Off Label Use, Duodenal Ulcer Perforation, Abortion
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Cytotec
Possible Cytotec side effects in 37 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2011-11-18
Patient: 37 year old female
Reactions: Third Stage Postpartum Haemorrhage, Haemoglobin Decreased, Off Label Use, Fibrinolysis, Caesarean Section, Uterine Atony, Maternal Exposure During Pregnancy
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Cytotec
Possible Cytotec side effects in 45 year old female
Reported by a physician from Norway on 2011-10-13
Patient: 45 year old female
Reactions: Off Label Use, Cardiac Failure
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Cytotec
Administration route: Oral
Indication: Abortion Spontaneous
Start date: 2011-07-31
End date: 2011-07-31
Cytotec
Indication: Vaginal Haemorrhage
Possible Cytotec side effects in 67 year old female
Reported by a physician from Germany on 2011-10-07
Patient: 67 year old female, weighing 70.0 kg (154.0 pounds)
Reactions: Off Label Use, Abdominal Pain Lower, Abasia, Peripheral Vascular Disorder, Chills, Pyrexia, Asthenia
Drug(s) suspected as cause:
Cytotec
Possible Cytotec side effects in female
Reported by a physician from United Kingdom on 2011-10-06
Patient: female
Reactions: Off Label Use, Incorrect Dose Administered, Uterine Rupture
Adverse event resulted in: death
Drug(s) suspected as cause:
Cytotec
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