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Ammonul (Sodium Phenylacetate / Sodium Benzoate) - Side Effect Reports to FDA

 
 



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)Device Related Sepsis (1)Maternal Exposure During Pregnancy (1)Abortion Induced (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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