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Ammonul (Sodium Phenylacetate / Sodium Benzoate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The safety data were obtained from 316 patients who received AMMONUL® as emergency (rescue) or prospective treatment for hyperammonemia as part of an uncontrolled, open-label study. The study population included patients between the ages of 0 to 53 years with a mean (SD) of 6.2 (8.54) years; 51% were male and 49% were female who had the following diagnoses: OTC (46%), ASS (22%), CPS (12%), ASL (2%), ARG (< 1%), THN (< 1%), and other (18%).

Table 2 Adverse Events Occurring in ≥ 3% of Patients Treated with AMMONUL®
Patients
N=316
No. patients with any adverse event163 (52%)
Blood and lymphatic system disorders35 (11%)
        Anemia NOS12 (4%)
        Disseminated intravascular coagulation11 (3%)
Cardiac disorders28 (9%)
Gastrointestinal disorders42 (13%)
        Diarrhea NOS10 (3%)
        Nausea9 (3%)
        Vomiting NOS29 (9%)
General disorders and administration-site conditions45 (14%)
        Injection-site reaction NOS11 (3%)
        Pyrexia17 (5%)
Infections39 (12%)
        Urinary tract infection NOS9 (3%)
Injury, poisoning and procedural complications12 (4%)
Investigations32 (10%)
Metabolism and nutrition disorders67 (21%)
        Acidosis NOS8 (3%)
        Hyperammonemia17 (5%)
        Hyperglycemia NOS22 (7%)
        Hypocalcemia8 (3%)
        Hypokalemia23 (7%)
        Metabolic acidosis NOS13 (4%)
Nervous system disorders71 (22%)
        Brain edema17 (5%)
        Coma10 (3%)
        Convulsions NOS19 (6%)
        Mental impairment NOS18 (6%)
Psychiatric disorders16 (5%)
        Agitation8 (3%)
Renal and urinary disorders14 (4%)
Respiratory, thoracic and mediastinal disorders47 (15%)
        Respiratory distress9 (3%)
Skin and subcutaneous tissue disorders19 (6%)
Vascular disorders19 (6%)
        Hypotension NOS14 (4%)

Clinically Important Adverse Reactions

Adverse events occurred most frequently in the following system organ classes: nervous system disorders (22% of patients), metabolism and nutrition disorders (21% of patients), and respiratory, thoracic and mediastinal disorders (15% of patients). The most frequently reported adverse events were vomiting (9% of patients), hyperglycemia (7% of patients), hypokalemia (7% of patients), convulsions (6% of patients), and mental impairment (6% of patients).

Adverse events leading to study drug discontinuation occurred in 4% of patients. Metabolic acidosis and injection-site reactions each led to discontinuation in 2 patients (< 1%). Adverse events leading to discontinuation in 1 patient included bradycardia, abdominal distension, injection-site extravasation, injection-site hemorrhage, blister, overdose, subdural hematoma, hyperammonemia, hypoglycemia, clonus, coma, increased intercranial pressure, hypercapnia, Kussmaul respiration, respiratory distress, respiratory failure, pruritis, and maculo-papular rash.

Subpopulation and Risk Factor Data

Adverse events were reported with similar frequency in patients with OTC, ASS, CPS, and diagnoses categorized as "other." Nervous system disorders were more frequent in patients with OTC and CPS, compared with patients with ASS and patients with "other" diagnoses. Convulsions and mental impairment were reported in patients with OTC and CPS. These observations are consistent with literature reports that patients with enzyme deficiencies occurring earlier in the urea cycle (i.e., OTC and CPS) tend to be more severely affected.

Adverse event profiles did differ by age group. Patients ≤ 30 days of age had more blood and lymphatic system disorders and vascular disorders (specifically hypotension), while patients > 30 days of age had more gastrointestinal disorders (specifically nausea, vomiting and diarrhea).

Other Less Common Adverse Events Occurring in < 3% of Patients

Less common adverse events that could represent drug-induced reactions or are characterized as severe are listed below by body system.

BLOOD AND LYMPHATIC SYSTEM DISORDERS: coagulopathy, pancytopenia, thrombocytopenia

CARDIAC DISORDERS: atrial rupture, cardiac or cardiopulmonary arrest/failure, cardiogenic shock, cardiomyopathy, pericardial effusion

EYE DISORDERS: blindness

GASTROINTESTINAL DISORDERS: gastrointestinal hemorrhage

GENERAL DISORDERS AND ADMINISTRATION-SITE CONDITIONS: asthenia, brain death, chest pain, multiorgan failure, edema

HEPATOBILIARY DISORDERS: cholestasis, hepatic artery stenosis, hepatic failure/ hepatotoxicity, jaundice

INFECTIONS AND INFESTATIONS: sepsis/septic shock

INJURY, POISONING AND PROCEDURAL COMPLICATIONS: brain herniation, subdural hematoma

INVESTIGATIONS: blood carbon dioxide changes, blood glucose changes, blood pH increased, cardiac output decreased, pCO2 changes, respiratory rate increased

METABOLISM AND NUTRITION DISORDERS: alkalosis, dehydration, fluid overload/retention, hyperkalemia, hypernatremia, alkalosis, tetany

NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED: hemangioma acquired

NERVOUS SYSTEM DISORDERS: areflexia, ataxia, brain infarction, brain hemorrhage, cerebral atrophy, clonus, depressed level of consciousness, encephalopathy, nerve paralysis, intracranial pressure increased, tremor

PSYCHIATRIC DISORDERS: acute psychosis, aggression, confusional state, hallucinations

RENAL AND URINARY DISORDERS: anuria, renal failure, urinary retention

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS: acute respiratory distress syndrome, dyspnea, hypercapnia, hyperventilation, Kussmaul respiration, pneumonia aspiration, pneumothorax, pulmonary hemorrhage, pulmonary edema, respiratory acidosis or alkalosis, respiratory arrest/failure

SKIN AND SUBCUTANEOUS TISSUE DISORDERS: alopecia, pruritis generalized, rash, urticaria

VASCULAR DISORDERS: flushing, hemorrhage, hypertension, phlebothrombosis/thrombosis



REPORTS OF SUSPECTED AMMONUL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Ammonul. The information is not vetted and should not be considered as verified clinical evidence.

Possible Ammonul side effects / adverse reactions 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

Suspect drug(s):
Ammonul

Other drugs received by patient: Amino Acid Supplementation; LMW Heparin; Citrulline; B6; B9



See index of all Ammonul side effect reports >>

Drug label data at the top of this Page last updated: 2007-04-17

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