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Cytotec (Misoprostol) - Off Label Use - Suspected Cause - Side Effect Reports

 
 



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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