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%).
| 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
TopSide 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.
TopMore Ammonul resources
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