AMANTADINE

Amantadine Adverse Events Reported to the FDA Over Time

How are Amantadine adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Amantadine, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Amantadine is flagged as the suspect drug causing the adverse event.

Most Common Amantadine Adverse Events Reported to the FDA

What are the most common Amantadine adverse events reported to the FDA?

Hallucination	69 (1.8%)
Dyskinesia	52 (1.36%)
Hallucination, Visual	51 (1.33%)
Fall	42 (1.09%)
Tremor	42 (1.09%)
Convulsion	40 (1.04%)
Delirium	40 (1.04%)
Condition Aggravated	37 (.96%)
Pyrexia	34 (.89%)
Confusional State	33 (.86%)
Neuroleptic Malignant Syndrome	33 (.86%)
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Completed Suicide	32 (.83%)
Drug Toxicity	32 (.83%)
Insomnia	31 (.81%)
Gait Disturbance	30 (.78%)
Somnolence	30 (.78%)
Corneal Oedema	27 (.7%)
Drug Interaction	26 (.68%)
Myoclonus	26 (.68%)
Oedema Peripheral	25 (.65%)
Vomiting	25 (.65%)
Abnormal Behaviour	24 (.63%)
Agitation	24 (.63%)
Psychotic Disorder	24 (.63%)
Depression	23 (.6%)
Drug Ineffective	23 (.6%)
Hallucinations, Mixed	23 (.6%)
Rhabdomyolysis	22 (.57%)
Pneumonia	21 (.55%)
Renal Impairment	21 (.55%)
Aggression	20 (.52%)
Cerebrovascular Accident	20 (.52%)
Dehydration	20 (.52%)
Blood Creatine Phosphokinase Increa...	19 (.5%)
Asthenia	18 (.47%)
Delusion	18 (.47%)
Depressed Level Of Consciousness	18 (.47%)
Dyspnoea	18 (.47%)
Hallucination, Auditory	18 (.47%)
Hypertension	18 (.47%)
Dopamine Dysregulation Syndrome	17 (.44%)
Loss Of Consciousness	17 (.44%)
Overdose	17 (.44%)
Anaemia	16 (.42%)
Dysstasia	16 (.42%)
Fatigue	16 (.42%)
Hyponatraemia	16 (.42%)
Nausea	16 (.42%)
Pathological Gambling	16 (.42%)
Speech Disorder	16 (.42%)
Cardiac Arrest	15 (.39%)
Decreased Appetite	15 (.39%)
Dysphagia	15 (.39%)
Hypotonia	15 (.39%)
Muscular Weakness	15 (.39%)
Anxiety	14 (.36%)
Death	14 (.36%)
Hyperhidrosis	14 (.36%)
Muscle Rigidity	14 (.36%)
Renal Failure Acute	14 (.36%)
Sudden Onset Of Sleep	14 (.36%)
Blood Creatinine Increased	13 (.34%)
Disorientation	13 (.34%)
Hypoaesthesia	13 (.34%)
Orthostatic Hypotension	13 (.34%)
Vertigo	13 (.34%)
Alanine Aminotransferase Increased	12 (.31%)
Aspartate Aminotransferase Increase...	12 (.31%)
Dizziness	12 (.31%)
Hypersexuality	12 (.31%)
Medication Error	12 (.31%)
Urinary Tract Infection	12 (.31%)
Blood Pressure Decreased	11 (.29%)
Gamma-glutamyltransferase Increased	11 (.29%)
Headache	11 (.29%)
Hepatic Function Abnormal	11 (.29%)
Hiccups	11 (.29%)
Status Epilepticus	11 (.29%)
Syncope	11 (.29%)
Weight Decreased	11 (.29%)
Brain Oedema	10 (.26%)
Drug Abuse	10 (.26%)
Encephalopathy	10 (.26%)
Erythromelalgia	10 (.26%)
Haemoglobin Decreased	10 (.26%)
Liver Disorder	10 (.26%)
Malaise	10 (.26%)
Mental Status Changes	10 (.26%)
On And Off Phenomenon	10 (.26%)
Persecutory Delusion	10 (.26%)
Respiratory Failure	10 (.26%)
Serotonin Syndrome	10 (.26%)
Sleep Attacks	10 (.26%)
Akinesia	9 (.23%)
Blood Alkaline Phosphatase Increase...	9 (.23%)
Circulatory Collapse	9 (.23%)
Constipation	9 (.23%)
Dry Mouth	9 (.23%)
Inappropriate Antidiuretic Hormone ...	9 (.23%)
Motor Dysfunction	9 (.23%)
Multiple Drug Overdose Intentional	9 (.23%)

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This graph shows the top adverse events submitted to the FDA for Amantadine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Amantadine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Amantadine

What are the most common Amantadine adverse events reported to the FDA?

Neurological	271 (7.06%)
Disturbances In Thinking	213 (5.55%)
Movement Disorders	173 (4.51%)
Cardiac Arrhythmias	101 (2.63%)
Deliria	88 (2.29%)
Respiratory	84 (2.19%)
Infections - Pathogen Unspecified	79 (2.06%)
Therapeutic And Nontherapeutic Effe...	79 (2.06%)
Injuries	76 (1.98%)
Gastrointestinal Signs	74 (1.93%)
Sleep Disorders	73 (1.9%)
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Muscle	71 (1.85%)
Neuromuscular	70 (1.82%)
Epidermal And Dermal Conditions	69 (1.8%)
Medication Errors	65 (1.69%)
Seizures	62 (1.62%)
Anxiety Disorders	59 (1.54%)
Cardiac And Vascular Investigations	57 (1.49%)
Hematology Investigations	55 (1.43%)
Psychiatric	51 (1.33%)
Renal Disorders	51 (1.33%)
Electrolyte And Fluid Balance Condi...	50 (1.3%)
Hepatobiliary	47 (1.22%)
Chemical Injury And Poisoning	46 (1.2%)
Body Temperature Conditions	41 (1.07%)
Central Nervous System Vascular	41 (1.07%)
Enzyme	39 (1.02%)
Lower Respiratory Tract Disorders	38 (.99%)
Personality Disorders	37 (.96%)
Suicidal And Self-injurious Behavio...	37 (.96%)
Coronary Artery	36 (.94%)
Decreased And Nonspecific Blood Pre...	34 (.89%)
Hepatic And Hepatobiliary	34 (.89%)
Musculoskeletal And Connective Tiss...	34 (.89%)
Mental Impairment	32 (.83%)
Vision	32 (.83%)
Psychiatric And Behavioural Symptom...	31 (.81%)
Impulse Control	29 (.76%)
Ocular Infections, Irritations And ...	29 (.76%)
Fatal Outcomes	28 (.73%)
Anemias Nonhemolytic And Marrow Dep...	27 (.7%)
Depressed Mood Disorders	27 (.7%)
Lifestyle Issues	27 (.7%)
Appetite And General Nutritional	26 (.68%)
Myocardial	26 (.68%)
Schizophrenia And Other Psychotic	26 (.68%)
Vascular	26 (.68%)
Physical Examination Topics	24 (.63%)
Joint	22 (.57%)
Renal And Urinary Tract Investigati...	22 (.57%)
Changes In Physical Activity	20 (.52%)
Encephalopathies	20 (.52%)
Inner Ear And Viiith Cranial Nerve	20 (.52%)
Ocular Neuromuscular	20 (.52%)
Skin Appendage Conditions	20 (.52%)
Urinary Tract Signs	20 (.52%)
Sleep Disturbances	19 (.5%)
Vascular Hypertensive	19 (.5%)
Bacterial Infectious	18 (.47%)
Sexual Dysfunctions, Disturbances A...	18 (.47%)
Mood Disorders	17 (.44%)
Cardiac Valve	16 (.42%)
Gastrointestinal Motility And Defec...	16 (.42%)
Heart Failures	14 (.36%)
Hypothalamus And Pituitary Gland	14 (.36%)
Metabolic, Nutritional And Blood Ga...	14 (.36%)
Salivary Gland Conditions	13 (.34%)
Skin Vascular Abnormalities	13 (.34%)
Cardiac Disorder Signs	12 (.31%)
Headaches	11 (.29%)
Increased Intracranial Pressure And...	11 (.29%)
Pleural	11 (.29%)
Water, Electrolyte And Mineral	11 (.29%)
White Blood Cell	11 (.29%)
Communication Disorders	10 (.26%)
Glucose Metabolism Disorders	10 (.26%)
Manic And Bipolar Mood Disorders	10 (.26%)
Toxicology And Therapeutic Drug Mon...	10 (.26%)
Eye	9 (.23%)
Platelet	9 (.23%)
Pulmonary Vascular	9 (.23%)
Therapeutic Procedures And Supporti...	9 (.23%)
Bone And Joint Injuries	8 (.21%)
Demyelinating	8 (.21%)
Protein And Amino Acid Metabolism	8 (.21%)
Allergic Conditions	7 (.18%)
Hearing	7 (.18%)
Structural Brain	7 (.18%)
Vascular Inflammations	7 (.18%)
Viral Infectious	7 (.18%)
Arteriosclerosis, Stenosis, Vascula...	6 (.16%)
Connective Tissue Disorders	6 (.16%)
Hematological And Lymphoid Tissue T...	6 (.16%)
Ocular Structural Change, Deposit A...	6 (.16%)
Peripheral Neuropathies	6 (.16%)
Pregnancy, Labour, Delivery And Pos...	6 (.16%)
Upper Respiratory Tract Disorders	6 (.16%)
Cranial Nerve Disorders	5 (.13%)
Fetal And Neonatal	5 (.13%)
Fungal Infectious	5 (.13%)
Gastrointestinal Inflammatory Condi...	5 (.13%)

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This graph shows the top categories of adverse events submitted to the FDA for Amantadine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Amantadine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.