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Prometrium (Progesterone) - Off Label Use - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Off Label Use (10)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Prometrium (Progesterone) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Prometrium side effects in 36 year old female

Reported by a physician from Greece on 2012-06-04

Patient: 36 year old female

Reactions: Off Label Use, Premature Rupture of Membranes, Caesarean Section, Maternal Exposure During Pregnancy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prometrium

Other drugs received by patient: Calcium Carbonate; Paricalcitol; Vitamin B Complex CAP; Darbepoetin Alfa; Tinzaparin; Levocarnitine; Iron Sucrose; Sevelamer Hydrochloride; Tinzaparin; Folic Acid



Possible Prometrium side effects in 36 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-05-30

Patient: 36 year old female

Reactions: Off Label Use, Abortion Spontaneous

Drug(s) suspected as cause:
Aspirin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Prometrium
    Indication: Product Used FOR Unknown Indication



Possible Prometrium side effects in 39 year old female

Reported by a consumer/non-health professional from United States on 2012-05-15

Patient: 39 year old female, weighing 63.6 kg (139.8 pounds)

Reactions: Off Label Use, Thinking Abnormal, Fatigue

Drug(s) suspected as cause:
Prometrium
    Indication: Antioestrogen Therapy

Prometrium
    Dosage: take on days 11-28 of cycle at bedtime
    Indication: Endometriosis
    Start date: 2012-04-06

Other drugs received by patient: Thyroid TAB



Possible Prometrium side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-15

Patient: female, weighing 49.9 kg (109.9 pounds)

Reactions: Off Label Use, Asthma, Hypersensitivity, Urticaria, Headache, Upper Respiratory Tract Congestion

Drug(s) suspected as cause:
Prometrium



Possible Prometrium side effects in female

Reported by a physician from Greece on 2012-05-15

Patient: female

Reactions: Off Label Use, Caesarean Section, Premature Rupture of Membranes, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Folic Acid
    Indication: Product Used FOR Unknown Indication

Vitamin B Complex CAP
    Indication: Product Used FOR Unknown Indication

Paricalcitol
    Indication: Product Used FOR Unknown Indication

Prometrium
    Dosage: start at 22 weeks of pregnancy
    Indication: Prophylaxis of Abortion

Other drugs received by patient: Darbepoetin Alfa; Sevelamer Hydrochloride; Levocarnitine



Possible Prometrium side effects in female

Reported by a pharmacist from United States on 2012-05-15

Patient: female

Reactions: Off Label Use, Pruritus, Food Allergy, Urticaria, Eye Swelling, Infertility

Drug(s) suspected as cause:
Prometrium



Possible Prometrium side effects in 39 year old female

Reported by a consumer/non-health professional from United States on 2012-05-15

Patient: 39 year old female

Reactions: Off Label Use, Flatulence, Abdominal Distension

Drug(s) suspected as cause:
Prometrium



Possible Prometrium side effects in 31 year old female

Reported by a pharmacist from Canada on 2012-05-03

Patient: 31 year old female

Reactions: Off Label Use, Blindness Transient

Drug(s) suspected as cause:
Prometrium



Possible Prometrium side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-12

Patient: female

Reactions: Off Label Use, Abortion Spontaneous, Vaginal Haemorrhage

Drug(s) suspected as cause:
Prometrium
    Indication: Abortion Spontaneous
    Start date: 2011-01-01
    End date: 2011-05-01

Prometrium
    Indication: Prophylaxis
    Start date: 2011-05-01
    End date: 2011-06-01

Other drugs received by patient: Multi-Vitamins; Aspirin



Possible Prometrium side effects in 39 year old female

Reported by a consumer/non-health professional from Canada on 2012-04-02

Patient: 39 year old female

Reactions: Off Label Use, Abortion Spontaneous

Drug(s) suspected as cause:
Prometrium

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