This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ammonul 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 (5)
Death (3)
Reports by Reaction Type
Death (3),
Abortion Induced (1),
Device Related Sepsis (1),
Maternal Exposure During Pregnancy (1),
Ornithine Transcarbamoylase Deficiency (1)
Possible Ammonul side effects in male
Reported by a consumer/non-health professional from Turkey on 2012-06-18
Patient: male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Ammonul
Possible Ammonul side effects in 27 year old female
Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-05-17
Patient: 27 year old female
Reactions: Maternal Exposure During Pregnancy, Abortion Induced, Ornithine Transcarbamoylase Deficiency
Drug(s) suspected as cause:
Ammonul
Other drugs received by patient: Amino Acid Supplementation; LMW Heparin; Citrulline; B6; B9
Possible Ammonul side effects in female
Reported by a health professional (non-physician/pharmacist) from Turkey on 2011-12-28
Patient: female, weighing 3.6 kg (7.9 pounds)
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Ammonul
Other drugs received by patient: IV Lipid; Sodium Benzoate; Unspecified Antibiotics; L-Arginine; IV Calcium
Possible Ammonul side effects in male
Reported by a physician from Belgium on 2011-12-20
Patient: male
Reactions: Device Related Sepsis
Drug(s) suspected as cause:
Ammonul
Dosage: 250 mg/kg;qd 300 mg/kg;qd
Indication: Hyperammonaemia
End date: 2011-01-01
Ammonul
Dosage: 250 mg/kg;qd 300 mg/kg;qd
Indication: Hyperammonaemia
End date: 2011-01-01
Possible Ammonul side effects in female
Reported by a health professional (non-physician/pharmacist) from Turkey on 2011-12-12
Patient: female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Ammonul
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