Efficacy

Safety

SAFETY Adverse Events Occurring in ≥3% of Patients Treated With AMMONUL^®

Adverse Event	No. of Patients (%) (n=316)
Number of patients with any adverse event	163 (52%)
Blood and lymphatic system disorders Anemia Disseminated intravascular coagulation	35 (11%) 12 (4%) 11 (3%)
Cardiac disorders	28 (9%)
Gastrointestinal disorders Diarrhea Nausea Vomiting	42 (13%) 10 (3%) 9 (3%) 29 (9%)
General disorders and administration-site conditions Injection-site reactions Pyrexia	45 (14%) 11 (3%) 17 (5%)
Infections Urinary tract infection	39 (12%) 9 (3%)
Injury, poisoning, and procedural complications	12 (4%)
Investigations	32 (10%)
Metabolism and nutrition disorders Acidosis Hyperammonemia Hyperglycemia Hypocalcemia Hypokalemia Metabolic acidosis	67 (21%) 8 (3%) 17 (5%) 22 (7%) 8 (3%) 23 (7%) 13 (4%)
Nervous system disorders Brain edema Coma Convulsions Mental impairment	71 (22%) 17 (5%) 10 (3%) 19 (6%) 18 (6%)
Psychiatric disorders Agitation	16 (5%) 8 (3%)
Renal and urinary disorders	14 (4%)
Respiratory, thoracic, and mediastinal disorders Respiratory distress	47 (15%) 9 (3%)
Skin and subcutaneous tissue disorders	19 (6%)
Vascular disorders Hypotension	19 (6%) 14 (4%)

Adverse events leading to study drug discontinuation occurred in 4% of patients.
AMMONUL^® should not be administered to patients with known hypersensitivity to sodium phenylacetate or sodium benzoate.
See the prescribing information for a complete listing of warnings, precautions, drug interactions, and overdosage information.

Click here for important safety information

Click here for Full Prescribing Information