MODAFINIL

Modafinil Adverse Events Reported to the FDA Over Time

How are Modafinil adverse event reports trending over time?

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

Most Common Modafinil Adverse Events Reported to the FDA

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

Completed Suicide	45 (2.03%)
Somnolence	40 (1.81%)
Nausea	36 (1.63%)
Irritability	33 (1.49%)
Headache	31 (1.4%)
Drug Interaction	27 (1.22%)
Convulsion	26 (1.17%)
Drug Prescribing Error	25 (1.13%)
Urticaria	24 (1.08%)
Condition Aggravated	23 (1.04%)
Anorexia	22 (.99%)
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Insomnia	22 (.99%)
Agitation	21 (.95%)
Confusional State	20 (.9%)
Delirium	20 (.9%)
Hypersensitivity	19 (.86%)
Dehydration	18 (.81%)
Aggression	17 (.77%)
Anxiety	17 (.77%)
Cardiac Arrest	17 (.77%)
Suicide Attempt	17 (.77%)
Loss Of Consciousness	16 (.72%)
Abnormal Behaviour	15 (.68%)
Death	15 (.68%)
Mania	15 (.68%)
Respiratory Arrest	15 (.68%)
Drug Ineffective	14 (.63%)
Dyskinesia	14 (.63%)
Paranoia	13 (.59%)
Stevens-johnson Syndrome	13 (.59%)
Vomiting	13 (.59%)
Asthenia	12 (.54%)
Erythema Multiforme	12 (.54%)
Hypertension	12 (.54%)
Intentional Drug Misuse	12 (.54%)
Rash	12 (.54%)
Diarrhoea	11 (.5%)
Drug Exposure During Pregnancy	11 (.5%)
Fatigue	11 (.5%)
Hallucination	11 (.5%)
Pyrexia	11 (.5%)
Coxsackie Viral Infection	10 (.45%)
Depressed Mood	10 (.45%)
Depression	10 (.45%)
Dizziness	10 (.45%)
Drug Toxicity	10 (.45%)
Hallucination, Auditory	10 (.45%)
Impaired Gastric Emptying	10 (.45%)
Suicidal Ideation	10 (.45%)
Abdominal Pain Upper	9 (.41%)
Cardio-respiratory Arrest	9 (.41%)
Cataplexy	9 (.41%)
Gamma-glutamyltransferase Increased	9 (.41%)
Hyperhidrosis	9 (.41%)
Overdose	9 (.41%)
Restlessness	9 (.41%)
Acute Myocardial Infarction	8 (.36%)
Affect Lability	8 (.36%)
Ammonia Increased	8 (.36%)
Arthralgia	8 (.36%)
Blood Phosphorus Decreased	8 (.36%)
Drug Effect Decreased	8 (.36%)
Drug Withdrawal Syndrome	8 (.36%)
Dysuria	8 (.36%)
Malaise	8 (.36%)
Metabolic Disorder	8 (.36%)
Muscular Weakness	8 (.36%)
Oedema Peripheral	8 (.36%)
Oppositional Defiant Disorder	8 (.36%)
Pharyngitis	8 (.36%)
Poisoning	8 (.36%)
Speech Disorder	8 (.36%)
Viral Infection	8 (.36%)
Abdominal Pain	7 (.32%)
Dysstasia	7 (.32%)
Incorrect Dose Administered	7 (.32%)
Neurosis	7 (.32%)
Persecutory Delusion	7 (.32%)
Pregnancy On Oral Contraceptive	7 (.32%)
Swelling Face	7 (.32%)
Theft	7 (.32%)
Autism	6 (.27%)
Back Pain	6 (.27%)
Blister	6 (.27%)
Disorientation	6 (.27%)
Drug Dependence	6 (.27%)
Dyspnoea	6 (.27%)
General Physical Health Deteriorati...	6 (.27%)
Hyperkinesia	6 (.27%)
Impulsive Behaviour	6 (.27%)
Intentional Overdose	6 (.27%)
Intermittent Explosive Disorder	6 (.27%)
Lip Swelling	6 (.27%)
Post-traumatic Stress Disorder	6 (.27%)
Product Substitution Issue	6 (.27%)
Status Epilepticus	6 (.27%)
Subdural Haematoma	6 (.27%)
Tachycardia	6 (.27%)
Tic	6 (.27%)
Treatment Noncompliance	6 (.27%)
Urinary Retention	6 (.27%)

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This graph shows the top adverse events submitted to the FDA for Modafinil, 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 Modafinil 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 Modafinil

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

Neurological	124 (5.6%)
Suicidal And Self-injurious Behavio...	82 (3.71%)
Therapeutic And Nontherapeutic Effe...	78 (3.52%)
Epidermal And Dermal Conditions	76 (3.43%)
Gastrointestinal Signs	74 (3.34%)
Anxiety Disorders	69 (3.12%)
Medication Errors	69 (3.12%)
Cardiac Arrhythmias	54 (2.44%)
Deliria	46 (2.08%)
Movement Disorders	46 (2.08%)
Respiratory	46 (2.08%)
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Seizures	46 (2.08%)
Personality Disorders	43 (1.94%)
Disturbances In Thinking	40 (1.81%)
Psychiatric	37 (1.67%)
Chemical Injury And Poisoning	36 (1.63%)
Headaches	34 (1.54%)
Sleep Disorders	32 (1.45%)
Appetite And General Nutritional	31 (1.4%)
Depressed Mood Disorders	29 (1.31%)
Infections - Pathogen Unspecified	29 (1.31%)
Hepatobiliary	28 (1.27%)
Viral Infectious	28 (1.27%)
Gastrointestinal Motility And Defec...	26 (1.17%)
Allergic Conditions	25 (1.13%)
Angiedema And Urticaria	25 (1.13%)
Manic And Bipolar Mood Disorders	25 (1.13%)
Electrolyte And Fluid Balance Condi...	24 (1.08%)
Changes In Physical Activity	23 (1.04%)
Injuries	21 (.95%)
Muscle	21 (.95%)
Hepatic And Hepatobiliary	20 (.9%)
Urinary Tract Signs	20 (.9%)
Mental Impairment	18 (.81%)
Mood Disorders	18 (.81%)
Vision	18 (.81%)
Water, Electrolyte And Mineral	18 (.81%)
Fatal Outcomes	17 (.77%)
Lifestyle Issues	17 (.77%)
Neuromuscular	17 (.77%)
Psychiatric And Behavioural Symptom...	17 (.77%)
Body Temperature Conditions	16 (.72%)
Coronary Artery	16 (.72%)
Musculoskeletal And Connective Tiss...	16 (.72%)
Impulse Control	15 (.68%)
Skin Appendage Conditions	14 (.63%)
Sleep Disturbances	14 (.63%)
Vascular Hypertensive	14 (.63%)
Cognitive And Attention Disorders	12 (.54%)
Oral Soft Tissue Conditions	12 (.54%)
Central Nervous System Vascular	11 (.5%)
Enzyme	11 (.5%)
Joint	11 (.5%)
Physical Examination Topics	11 (.5%)
Pregnancy, Labour, Delivery And Pos...	11 (.5%)
Schizophrenia And Other Psychotic	11 (.5%)
Cardiac Disorder Signs	10 (.45%)
Metabolism	10 (.45%)
Product Quality Issues	10 (.45%)
Cardiac And Vascular Investigations	9 (.41%)
Decreased And Nonspecific Blood Pre...	8 (.36%)
Gastrointestinal Inflammatory Condi...	8 (.36%)
Legal Issues	8 (.36%)
White Blood Cell	8 (.36%)
Arteriosclerosis, Stenosis, Vascula...	7 (.32%)
Gastrointestinal Neoplasms Malignan...	7 (.32%)
Hematology Investigations	7 (.32%)
Bacterial Infectious	6 (.27%)
Cardiac And Vascular Disorders Cong...	6 (.27%)
Ocular Neuromuscular	6 (.27%)
Renal Disorders	6 (.27%)
Thyroid Gland	6 (.27%)
Tongue Conditions	6 (.27%)
Abortions And Stillbirth	5 (.23%)
Acid-base	5 (.23%)
Bone Disorders	5 (.23%)
Communication Disorders	5 (.23%)
Economic And Housing Issues	5 (.23%)
Lower Respiratory Tract Disorders	5 (.23%)
Renal And Urinary Tract Investigati...	5 (.23%)
Somatoform And Factitious	5 (.23%)
Spleen, Lymphatic And Reticulendoth...	5 (.23%)
Therapeutic Procedures And Supporti...	5 (.23%)
Toxicology And Therapeutic Drug Mon...	5 (.23%)
Anemias Nonhemolytic And Marrow Dep...	4 (.18%)
Gallbladder	4 (.18%)
Gastrointestinal Conditions	4 (.18%)
Metabolic, Nutritional And Blood Ga...	4 (.18%)
Miscellaneous And Site Unspecified ...	4 (.18%)
Myocardial	4 (.18%)
Pleural	4 (.18%)
Dissociative	3 (.14%)
Encephalopathies	3 (.14%)
Exocrine Pancreas Conditions	3 (.14%)
Family Issues	3 (.14%)
Gastrointestinal Hemorrhages	3 (.14%)
Inner Ear And Viiith Cranial Nerve	3 (.14%)
Mycobacterial Infectious	3 (.14%)
Neurological Disorders Of The Eye	3 (.14%)
Ocular Structural Change, Deposit A...	3 (.14%)
Procedural And Device Related Injur...	3 (.14%)

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This graph shows the top categories of adverse events submitted to the FDA for Modafinil, 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 Modafinil 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.