SODIUM PHENYLBUTYRATE for Hyperammonaemia: Side Effects & Safety Data
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There are 13 adverse event reports in the FDA FAERS database where SODIUM PHENYLBUTYRATE was used for Hyperammonaemia.
Most Reported Side Effects for SODIUM PHENYLBUTYRATE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Hyperammonaemia | 43 | 14.3% | 5 | 34 |
| Vomiting | 31 | 10.3% | 1 | 14 |
| Off label use | 29 | 9.7% | 9 | 4 |
| Nausea | 22 | 7.3% | 0 | 4 |
| Death | 20 | 6.7% | 18 | 2 |
| Ammonia increased | 19 | 6.3% | 0 | 15 |
| Hyperammonaemic crisis | 19 | 6.3% | 4 | 13 |
| Product use complaint | 14 | 4.7% | 0 | 0 |
| Retching | 14 | 4.7% | 0 | 2 |
| Decreased appetite | 13 | 4.3% | 0 | 3 |
| Abdominal pain upper | 10 | 3.3% | 0 | 3 |
| Diarrhoea | 10 | 3.3% | 0 | 6 |
| Headache | 10 | 3.3% | 0 | 1 |
| Seizure | 10 | 3.3% | 1 | 4 |
| Drug ineffective | 9 | 3.0% | 3 | 3 |
Other Indications for SODIUM PHENYLBUTYRATE
Ornithine transcarbamoylase deficiency (89)
Product used for unknown indication (39)
Urea cycle disorder (39)
Urea cycle enzyme deficiency (28)
Argininosuccinate synthetase deficiency (19)
Amyotrophic lateral sclerosis (9)
Argininosuccinate lyase deficiency (8)
Arginase deficiency (7)
Carbamoyl phosphate synthetase deficiency (7)
Progressive familial intrahepatic cholestasis (6)
Other Drugs Used for Hyperammonaemia
CARGLUMIC ACID (114)
RIFAXIMIN (88)
LACTULOSE (57)
SODIUM\SODIUM PHENYLACETATE (16)
GLYCEROL PHENYLBUTYRATE (14)
LEVOCARNITINE (13)
SODIUM (13)
ARGININE (12)
ACARBOSE (5)