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PRIMIDONE

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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?

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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.

Common Uses of Primidone According to Those Reporting Adverse Events

Why are people taking Primidone, according to those reporting adverse events to the FDA?

Tremor
162
Epilepsy
154
Convulsion
89
Drug Use For Unknown Indication
70
Product Used For Unknown Indication
63
Essential Tremor
47
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Parkinsons Disease
18
Petit Mal Epilepsy
17
Ill-defined Disorder
11
Pain
9
Complex Partial Seizures
7
Migraine
7
Cerebellar Ataxia
6
Familial Tremor
5
Prophylaxis
4
Grand Mal Convulsion
4
Multiple Sclerosis
3
Maternal Exposure During Pregnancy
3
Headache
3
Nerve Injury
2
Head Titubation
2
Neuropathy Peripheral
2
Simple Partial Seizures
2
Sleep Disorder
2
Bipolar Disorder
2
Depression
2
Nervousness
2
Anxiety
2
Insomnia
2
Myalgia
2
Foetal Exposure During Pregnancy
2
Systemic Antiviral Treatment
1
Memory Impairment
1
Drug Exposure During Pregnancy
1
Drug Exposure Via Breast Milk
1
Juvenile Myoclonic Epilepsy
1
Nervous System Disorder
1
Balance Disorder
1
Benign Neoplasm
1
Partial Seizures
1
Restless Legs Syndrome
1
Convulsion Prophylaxis
1
Myoclonic Epilepsy
1
Cerebral Palsy
1
Familial Risk Factor
1
Hypertension
1
Dementia Alzheimers Type
1
Encephalopathy
1

Drug Labels

LabelLabelerEffective
PrimidoneAvKARE, Inc.03-MAR-09
PrimidoneDr. Reddy's Laboratories Ltd19-MAR-10
MysolineValeant Pharmaceuticals North America02-AUG-10
PrimidoneQualitest Pharmaceuticals15-SEP-10
PrimidoneGlobal Pharmaceuticals28-SEP-10
PrimidoneLannett Company, Inc.22-NOV-10
PrimidoneNCS HealthCare of KY, Inc dba Vangard Labs04-FEB-11
PrimidoneMajor Pharmaceuticals07-APR-11
PrimidoneWatson Laboratories, Inc.13-APR-11
Primidone AvPAK19-MAY-11
PrimidoneAmerican Health Packaging24-MAY-11
PrimidoneGolden State Medical Supply, Inc.01-JUL-11
PrimidoneCardinal Health05-OCT-11
PrimidoneWest-ward Pharmaceutical Corp14-DEC-11
PrimidoneMcKesson Contract Packaging11-JAN-12
PrimidoneSTAT Rx USA LLC24-MAY-12
PrimidoneMajor Pharmaceuticals11-JUL-12
PrimidoneAmneal Pharmaceuticals15-AUG-12
PrimidoneNCS HealthCare of KY, Inc dba Vangard Labs13-NOV-12
PrimidonePhysicians Total Care, Inc.19-FEB-13

Primidone Case Reports

What Primidone safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Primidone. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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