PRIMIDONE

Primidone Adverse Events Reported to the FDA Over Time

How are Primidone adverse event reports trending over time?

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

Most Common Primidone Adverse Events Reported to the FDA

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

Convulsion	42 (2.82%)
Drug Ineffective	31 (2.08%)
Completed Suicide	30 (2.01%)
Drug Interaction	25 (1.68%)
Dizziness	24 (1.61%)
Somnolence	24 (1.61%)
Tremor	23 (1.54%)
Blindness Transient	20 (1.34%)
Hyperacusis	20 (1.34%)
Cardiac Arrest	19 (1.28%)
Deafness Transitory	19 (1.28%)
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Fall	18 (1.21%)
Feeling Abnormal	18 (1.21%)
Loss Of Consciousness	17 (1.14%)
Nausea	14 (.94%)
Asthenia	13 (.87%)
Condition Aggravated	13 (.87%)
Erythema	12 (.81%)
Hypertension	12 (.81%)
Liver Injury	12 (.81%)
Multiple Drug Overdose	12 (.81%)
Pruritus	11 (.74%)
Depression	10 (.67%)
Grand Mal Convulsion	9 (.6%)
Hyperhidrosis	9 (.6%)
Maternal Drugs Affecting Foetus	9 (.6%)
Microtia	9 (.6%)
Patent Ductus Arteriosus	9 (.6%)
Swelling Face	9 (.6%)
Balance Disorder	8 (.54%)
Blood Creatine Phosphokinase Increa...	8 (.54%)
Coma	8 (.54%)
Drug Toxicity	8 (.54%)
Headache	8 (.54%)
Medication Error	8 (.54%)
Pneumonia	8 (.54%)
Respiratory Arrest	8 (.54%)
Syndactyly	8 (.54%)
Ataxia	7 (.47%)
Auricular Swelling	7 (.47%)
Body Height Decreased	7 (.47%)
Drug Hypersensitivity	7 (.47%)
Epilepsy	7 (.47%)
Fatigue	7 (.47%)
Hepatic Enzyme Increased	7 (.47%)
Petit Mal Epilepsy	7 (.47%)
Stevens-johnson Syndrome	7 (.47%)
Therapeutic Response Unexpected Wit...	7 (.47%)
Weight Increased	7 (.47%)
Cardio-respiratory Arrest	6 (.4%)
Diplopia	6 (.4%)
Disturbance In Attention	6 (.4%)
Drug Withdrawal Convulsions	6 (.4%)
Dysgraphia	6 (.4%)
Gait Disturbance	6 (.4%)
Insomnia	6 (.4%)
Oedema Peripheral	6 (.4%)
Osteoporosis	6 (.4%)
Overdose	6 (.4%)
Rash	6 (.4%)
White Blood Cell Count Decreased	6 (.4%)
Abdominal Pain Upper	5 (.34%)
Alveolitis	5 (.34%)
Anorexia	5 (.34%)
Choanal Atresia	5 (.34%)
Coloboma	5 (.34%)
Complex Partial Seizures	5 (.34%)
Confusional State	5 (.34%)
Contusion	5 (.34%)
Coordination Abnormal	5 (.34%)
Drug Exposure During Pregnancy	5 (.34%)
Hallucination	5 (.34%)
Malaise	5 (.34%)
Pain	5 (.34%)
Platelet Count Decreased	5 (.34%)
Pulmonary Fibrosis	5 (.34%)
Pyrexia	5 (.34%)
Speech Disorder	5 (.34%)
Vomiting	5 (.34%)
Yawning	5 (.34%)
Agitation	4 (.27%)
Amnesia	4 (.27%)
Anticonvulsant Drug Level Increased	4 (.27%)
Arthralgia	4 (.27%)
Aura	4 (.27%)
Blood Creatinine Increased	4 (.27%)
Blood Pressure Increased	4 (.27%)
Bradycardia	4 (.27%)
Cleft Lip	4 (.27%)
Conjunctival Hyperaemia	4 (.27%)
Corneal Erosion	4 (.27%)
Death	4 (.27%)
Disseminated Intravascular Coagulat...	4 (.27%)
Dyspnoea	4 (.27%)
Feeling Hot	4 (.27%)
Genital Haemorrhage	4 (.27%)
Histiocytosis Haematophagic	4 (.27%)
Ill-defined Disorder	4 (.27%)
Influenza	4 (.27%)
International Normalised Ratio Incr...	4 (.27%)
Lip Erosion	4 (.27%)

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

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

Neurological	136 (9.13%)
Seizures	81 (5.44%)
Therapeutic And Nontherapeutic Effe...	74 (4.97%)
Epidermal And Dermal Conditions	53 (3.56%)
Cardiac Arrhythmias	42 (2.82%)
Hearing	42 (2.82%)
Movement Disorders	38 (2.55%)
Medication Errors	37 (2.48%)
Injuries	33 (2.21%)
Gastrointestinal Signs	31 (2.08%)
Suicidal And Self-injurious Behavio...	31 (2.08%)
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Vision	30 (2.01%)
Hepatic And Hepatobiliary	28 (1.88%)
Chemical Injury And Poisoning	25 (1.68%)
Hematology Investigations	25 (1.68%)
Respiratory	25 (1.68%)
Physical Examination Topics	20 (1.34%)
Cardiac And Vascular Disorders Cong...	18 (1.21%)
Hepatobiliary	17 (1.14%)
Lower Respiratory Tract Disorders	17 (1.14%)
Musculoskeletal And Connective Tiss...	17 (1.14%)
Infections - Pathogen Unspecified	16 (1.07%)
Mental Impairment	15 (1.01%)
Joint	14 (.94%)
Toxicology And Therapeutic Drug Mon...	13 (.87%)
Allergic Conditions	12 (.81%)
Anxiety Disorders	12 (.81%)
Cardiac And Vascular Investigations	12 (.81%)
Depressed Mood Disorders	12 (.81%)
Vascular Hypertensive	12 (.81%)
Enzyme	11 (.74%)
Headaches	11 (.74%)
Muscle	11 (.74%)
Skin Appendage Conditions	11 (.74%)
Body Temperature Conditions	10 (.67%)
Bone And Joint Injuries	10 (.67%)
Electrolyte And Fluid Balance Condi...	10 (.67%)
Musculoskeletal And Connective Tiss...	10 (.67%)
Sleep Disorders	10 (.67%)
Ear And Labyrinthine Disorders Cong...	9 (.6%)
Gastrointestinal Motility And Defec...	9 (.6%)
Lifestyle Issues	9 (.6%)
Renal Disorders	9 (.6%)
Bone Disorders	8 (.54%)
Deliria	8 (.54%)
Disturbances In Thinking	8 (.54%)
Hematopoietic Neoplasms	8 (.54%)
Psychiatric	8 (.54%)
Renal And Urinary Tract Investigati...	8 (.54%)
Appetite And General Nutritional	7 (.47%)
External Ear Disorders	7 (.47%)
Anemias Nonhemolytic And Marrow Dep...	6 (.4%)
Changes In Physical Activity	6 (.4%)
Pregnancy, Labour, Delivery And Pos...	6 (.4%)
Product Quality Issues	6 (.4%)
Eye Disorders Congenital	5 (.34%)
Glucose Metabolism Disorders	5 (.34%)
Metabolic, Nutritional And Blood Ga...	5 (.34%)
Neuromuscular	5 (.34%)
Ocular Infections, Irritations And ...	5 (.34%)
Respiratory Disorders Congenital	5 (.34%)
Urinary Tract Signs	5 (.34%)
Viral Infectious	5 (.34%)
Abortions And Stillbirth	4 (.27%)
Anterior Eye Structural Change, Dep...	4 (.27%)
Benign Neoplasms Gastrointestinal	4 (.27%)
Coagulopathies And Bleeding Diathes...	4 (.27%)
Fatal Outcomes	4 (.27%)
Oral Soft Tissue Conditions	4 (.27%)
Peripheral Neuropathies	4 (.27%)
Reproductive Tract	4 (.27%)
Spleen, Lymphatic And Reticulendoth...	4 (.27%)
Vascular Hemorrhagic	4 (.27%)
Breast Neoplasms Malignant And Unsp...	3 (.2%)
Cardiac Disorder Signs	3 (.2%)
Communication Disorders	3 (.2%)
Cranial Nerve Disorders	3 (.2%)
Embolism And Thrombosis	3 (.2%)
Encephalopathies	3 (.2%)
Endocrine Investigations	3 (.2%)
Fungal Infectious	3 (.2%)
Gastrointestinal Inflammatory Condi...	3 (.2%)
Gastrointestinal Tract Disorders Co...	3 (.2%)
Inner Ear And Viiith Cranial Nerve	3 (.2%)
Lipid Metabolism	3 (.2%)
Miscellaneous And Site Unspecified ...	3 (.2%)
Mood Disorders	3 (.2%)
Musculoskeletal And Connective Tiss...	3 (.2%)
Neonatal And Perinatal Conditions	3 (.2%)
Nephropathies	3 (.2%)
Neurological Disorders Congenital	3 (.2%)
Ocular Structural Change, Deposit A...	3 (.2%)
Protein And Amino Acid Metabolism	3 (.2%)
Sleep Disturbances	3 (.2%)
Tissue	3 (.2%)
Vascular	3 (.2%)
Vitamin Related	3 (.2%)
Water, Electrolyte And Mineral	3 (.2%)
Arteriosclerosis, Stenosis, Vascula...	2 (.13%)
Bacterial Infectious	2 (.13%)
Bladder And Bladder Neck Disorders	2 (.13%)

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