Ammonul Side Effects

Please note - some side effects for Ammonul may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Ammonul Side Effects - for the Professional

Ammonul

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

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 Reactions Occurring in ≥ 3% of Patients Treated with Ammonul

	Patients N=316
Number of patients with any adverse event	163 (52%)
Blood and lymphatic system disorders	35 (11%)
Anemia	12 (4%)
Disseminated intravascular coagulation	11 (3%)
Cardiac disorders	28 (9%)
Gastrointestinal disorders	42 (13%)
Diarrhea	10 (3%)
Nausea	9 (3%)
Vomiting	29 (9%)
General disorders and administration-site conditions	45 (14%)
Injection-site reaction	11 (3%)
Pyrexia	17 (5%)
Infections	39 (12%)
Urinary tract infection	9 (3%)
Injury, poisoning and procedural complications	12 (4%)
Investigations	32 (10%)
Metabolism and nutrition disorders	67 (21%)
Acidosis	8 (3%)
Hyperammonemia	17 (5%)
Hyperglycemia	22 (7%)
Hypocalcemia	8 (3%)
Hypokalemia	23 (7%)
Metabolic acidosis	13 (4%)
Nervous system disorders	71 (22%)
Brain edema	17 (5%)
Coma	10 (3%)
Convulsions	19 (6%)
Mental impairment	18 (6%)
Psychiatric disorders	16 (5%)
Agitation	8 (3%)
Renal and urinary disorders	14 (4%)
Respiratory, thoracic and mediastinal disorders	47 (15%)
Respiratory distress	9 (3%)
Skin and subcutaneous tissue disorders	19 (6%)
Vascular disorders	19 (6%)
Hypotension	14 (4%)

Adverse reactions 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 reactions profiles differed 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).

Less common adverse reactions (< 3% of patients) that are characterized as severe are listed below by body system.

BLOOD AND LYMPHATIC SYSTEM DISORDERS: coagulopathy, pancytopenia, thrombocytopenia

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

EYE DISORDERS: blindness

GASTROINTESTINAL DISORDERS: abdominal distension, 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, overdose

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, hypoglycemia, 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, subdural hematoma, 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, blister, pruritis generalized, rash, urticaria

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

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Side Effects by Body System - for Healthcare Professionals

General

General side effects including infections (12%), pyrexia (5%), asthenia, chest pain, multiorgan failure, edema, and sepsis/septic shock have been reported.

Gastrointestinal

Gastrointestinal side effects including vomiting (9%), diarrhea (3%), nausea (3%), and gastrointestinal hemorrhage have been reported.

Metabolic

Metabolic side effects including hyperglycemia (7%), hypokalemia (7%), hyperammonemia (5%), metabolic acidosis (4%), hypocalcemia (3%), acidosis (3%), alkalosis, dehydration, fluid overload/retention, hyperkalemia, hypernatremia, alkalosis, tetany, blood glucose changes, and increased blood pH have been reported.

Nervous system

Nervous system side effects including convulsions (6%), mental impairment (6%), brain edema (5%), coma (3%), areflexia, ataxia, brain infarction, brain hemorrhage, cerebral atrophy, clonus, depressed level of consciousness, encephalopathy, nerve paralysis, increased intracranial pressure, and tremor have been reported.

Hematologic

Hematologic side effects including anemia (4%), disseminated intravascular coagulation (3%), coagulopathy, pancytopenia, and thrombocytopenia have been reported.

Cardiovascular

Cardiovascular side effects including hypotension (4%), atrial rupture, cardiac or cardiopulmonary arrest/failure, cardiogenic shock, cardiomyopathy, pericardial effusion, flushing, hemorrhage, hypertension, phlebothrombosis/thrombosis, and decreased cardiac output have been reported.

Respiratory

Respiratory side effects including respiratory distress (3%), acute respiratory distress syndrome, dyspnea, hypercapnia, hyperventilation, Kussmaul respiration, pneumonia aspiration, pneumothorax, pulmonary hemorrhage, pulmonary edema, respiratory acidosis or alkalosis, respiratory arrest/failure, blood carbon dioxide changes, pCO2 changes, and increased respiratory rate have been reported.

Psychiatric

Psychiatric side effects including agitation (3%), acute psychosis, aggression, confusional state, and hallucinations have been reported.

Local

Local side effects including injection-site reaction (3%) have been reported.

Genitourinary

Genitourinary side effects including urinary tract infection (3%) have been reported.

Dermatologic

Dermatologic side effects including alopecia, pruritus, generalized rash, and urticaria have been reported.

Hepatic

Hepatic side effects including cholestasis, hepatic artery stenosis, hepatic failure, hepatotoxicity, and jaundice have been reported.

Other

Other side effects including brain herniation, subdural hematoma, and brain death have been reported.

Renal

Renal side effects including anuria, renal failure, and urinary retention have been reported.

Ocular

Ocular side effects including blindness have been reported.

Oncologic

Oncologic side effects including acquired hemangioma have been reported.

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