This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Primidone and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (38)
Death (1)
Disability (2)
Reports by Reaction Type
Maternal Exposure Timing Unspecified (10),
Microtia (9),
Patent Ductus Arteriosus (9),
Syndactyly (8),
Coloboma (5),
Convulsion (5),
Choanal Atresia (5),
Maternal Drugs Affecting Foetus (4),
Drug Ineffective (4),
Speech Disorder (4),
Dizziness (4),
Cleft LIP (4)
Below are a few examples of reports where side effects / adverse reactions may be related to Primidone. For a complete list or a specific selection of reports, please use the links above.
Possible Primidone side effects in male
Reported by a physician from United States on 2012-08-06
Patient: male, weighing 83.0 kg (182.6 pounds)
Reactions: Electrocardiogram QT Prolonged
Drug(s) suspected as cause:
Primidone
Administration route: Oral
Indication: Essential Tremor
Start date: 2011-10-19
End date: 2012-02-15
Propulsid
Administration route: Oral
Indication: Gastrointestinal Motility Disorder
Start date: 2007-02-09
End date: 2012-02-24
Propulsid
Administration route: Oral
Indication: Gastrooesophageal Reflux Disease
Start date: 2007-02-09
End date: 2012-02-24
Other drugs received by patient: Klonopin; Zofran; Singulair; Pepcid; Magnesium Hydroxide TAB; Cialis; Nexium
Possible Primidone side effects in 57 year old male
Reported by a physician from Germany on 2012-07-30
Patient: 57 year old male
Reactions: Parkinson's Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Clarium
Indication: Parkinson's Disease
Start date: 2008-11-04
End date: 2008-11-08
Clarium
Start date: 2008-11-11
End date: 2009-03-12
Clarium
Start date: 2008-11-09
End date: 2008-11-10
Clarium
Dosage: dose decreased
Start date: 2010-10-04
Clarium
Dosage: frequency: other 2-1-1
Start date: 2009-11-10
End date: 2010-10-03
Clarium
Dosage: frequency: other 2-0-1
Start date: 2009-05-09
End date: 2009-11-09
Clarium
Dosage: dose: other 2-1-1
Start date: 2009-03-13
End date: 2009-06-08
Neupro
Start date: 2009-05-01
End date: 2009-05-07
Neupro
Start date: 2010-10-12
End date: 2010-10-12
Neupro
Start date: 2009-06-26
End date: 2010-10-04
Neupro
Start date: 2010-10-05
End date: 2010-10-07
Neupro
Start date: 2010-10-13
End date: 2010-10-13
Neupro
Start date: 2008-06-09
End date: 2008-06-19
Neupro
Start date: 2008-06-20
End date: 2008-06-22
Neupro
Start date: 2009-06-08
End date: 2009-06-25
Neupro
Start date: 2010-10-08
End date: 2010-10-11
Neupro
Start date: 2010-10-18
Neupro
Start date: 2008-06-23
End date: 2008-11-02
Neupro
Start date: 2009-03-03
End date: 2009-04-30
Neupro
Start date: 2010-10-14
End date: 2010-10-17
Neupro
Indication: Parkinson's Disease
Start date: 2008-06-04
End date: 2008-06-08
Neupro
Start date: 2008-11-10
End date: 2009-03-02
Neupro
Start date: 2008-11-03
End date: 2008-11-09
Primidone
Start date: 2008-11-04
End date: 2008-11-10
Primidone
Indication: Parkinson's Disease
Start date: 2008-07-07
End date: 2008-07-08
Primidone
Dosage: dose: other 2-0-1
Start date: 2008-09-16
End date: 2008-11-03
Primidone
Start date: 2008-07-10
End date: 2008-09-01
Primidone
Dosage: other 1-0-2
Start date: 2010-07-21
End date: 2010-09-20
Primidone
Start date: 2010-09-21
End date: 2010-10-04
Primidone
Start date: 2010-10-08
Primidone
Start date: 2008-11-11
End date: 2010-04-22
Primidone
Start date: 2008-07-09
End date: 2008-07-09
Primidone
Start date: 2010-04-23
End date: 2010-07-20
Primidone
Start date: 2010-10-05
End date: 2010-10-07
Selegelin
Indication: Parkinson's Disease
Start date: 2008-11-14
End date: 2010-10-04
Other drugs received by patient: Levothyroxine Sodium; Madopar Depot; Clonazepam; Protaphane; Madopar Depot; Protaphane; Novorapid; Clonazepam; Moviprep; Madopar Depot; Levothyroxine Sodium; Madopar Depot
Possible Primidone side effects in 86 year old female
Reported by a physician from United States on 2012-07-24
Patient: 86 year old female
Reactions: Grip Strength Decreased, Toxicity To Various Agents, Dysphemia
Drug(s) suspected as cause:
Donepezil HCL
Lithium Carbonate
Primidone
Risperidone
Possible Primidone side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19
Patient: female, weighing 63.5 kg (139.7 pounds)
Reactions: Rash Generalised, Drug Ineffective, Facial Pain, Speech Disorder, Facial Neuralgia, Balance Disorder, Palpitations, Heart Rate Increased, Dizziness, Mastication Disorder
Drug(s) suspected as cause:
Epitol
Dosage: unk
Indication: Nerve Injury
Start date: 2011-07-01
End date: 2011-01-01
Lyrica
Dosage: 50 mg, daily
Indication: Nerve Injury
Start date: 2011-01-01
Lyrica
Dosage: 100 mg, 3x/day
Primidone
Indication: Familial Tremor
Primidone
Dosage: unk
Indication: Nerve Injury
Start date: 2008-01-01
Propranolol Hydrochloride
Dosage: 80 mg, daily
Indication: Familial Tremor
Possible Primidone side effects in
Reported by a individual with unspecified qualification from United States on 2012-07-17
Patient:
Reactions: Product Name Confusion, Medication Error, Intercepted Drug Dispensing Error
Drug(s) suspected as cause:
Pregabalin
Primidone
Possible Primidone side effects in 54 year old male
Reported by a pharmacist from United States on 2012-06-26
Patient: 54 year old male, weighing 136.0 kg (299.2 pounds)
Reactions: Condition Aggravated, Depression, Tremor
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Primidone
Possible Primidone side effects in
Reported by a pharmacist from United States on 2012-06-19
Patient:
Reactions: Circumstance or Information Capable of Leading To Medication Error, Medication Error, Product Label Confusion
Drug(s) suspected as cause:
Primidone
Promethazine
Possible Primidone side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: female, weighing 63.5 kg (139.7 pounds)
Reactions: Rash Generalised, Drug Ineffective, Facial Pain, Speech Disorder, Facial Neuralgia, Balance Disorder, Palpitations, Heart Rate Increased, Mastication Disorder, Dizziness
Drug(s) suspected as cause:
Epitol
Dosage: unk
Indication: Nerve Injury
Start date: 2011-07-01
End date: 2011-01-01
Lyrica
Dosage: 100 mg, 3x/day
Lyrica
Dosage: 50 mg, daily
Indication: Nerve Injury
Start date: 2011-01-01
Primidone
Indication: Familial Tremor
Primidone
Dosage: unk
Indication: Nerve Injury
Start date: 2008-01-01
Propranolol HCL
Dosage: 80 mg, daily
Indication: Familial Tremor
Possible Primidone side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-12
Patient: female, weighing 79.4 kg (174.6 pounds)
Reactions: Rash
Drug(s) suspected as cause:
Primidone
Dosage: 50 mg qid
Indication: Essential Tremor
Start date: 2011-05-01
Primidone
Dosage: 50 mg qid
Indication: Essential Tremor
Start date: 2011-07-01
Possible Primidone side effects in 61 year old female
Reported by a consumer/non-health professional from United States on 2012-05-31
Patient: 61 year old female, weighing 122.0 kg (268.4 pounds)
Reactions: Type 2 Diabetes Mellitus, Femur Fracture, Osteoporosis, Abasia, Sensory Loss, Macular Degeneration, Fall, Abdominal Pain Upper, Neuropathy Peripheral, Spinal Deformity, Arthritis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Dilantin
Administration route: Oral
Indication: Epilepsy
Dilantin
Administration route: Oral
Primidone
Indication: Epilepsy
Topamax
Indication: Epilepsy
Possible Primidone side effects in 55 year old female
Reported by a physician from Germany on 2012-05-15
Patient: 55 year old female, weighing 100.0 kg (220.0 pounds)
Reactions: Accidental Overdose
Drug(s) suspected as cause:
Carbamazepine
Dosage: total dose:2400 mg (within 12 hours)
Administration route: Oral
Primidone
Dosage: total dose:1250 mg; 250 (5 tablets within 12 hours)
Administration route: Oral
Vimpat
Dosage: total dose:800mg;200 (4 tablets within a period of 12 hours)
Administration route: Oral
Possible Primidone side effects in male
Reported by a physician from Germany on 2012-05-11
Patient: male, weighing 3.1 kg (6.9 pounds)
Reactions: Syndactyly
Drug(s) suspected as cause:
Primidone
Valpro
Possible Primidone side effects in
Reported by a health professional (non-physician/pharmacist) from Hungary on 2012-03-20
Patient:
Reactions: Pulmonary Artery Stenosis Congenital, Foetal Exposure During Pregnancy, Kidney Malformation, Talipes, Congenital Absence of Vertebra, Rectal Stenosis, Microtia
Drug(s) suspected as cause:
Phenacemide
Indication: Foetal Exposure During Pregnancy
Phenobarbital TAB
Indication: Foetal Exposure During Pregnancy
Primidone
Dosage: unk
Indication: Foetal Exposure During Pregnancy
Possible Primidone side effects in
Reported by a health professional (non-physician/pharmacist) from Hungary on 2012-03-20
Patient:
Reactions: Syndactyly, Choanal Atresia, Patent Ductus Arteriosus, Foetal Exposure During Pregnancy, Coloboma, Microtia
Drug(s) suspected as cause:
Diazepam
Dosage: unk
Indication: Foetal Exposure During Pregnancy
Mephenytoin
Indication: Foetal Exposure During Pregnancy
Phenytoin
Indication: Foetal Exposure During Pregnancy
Primidone
Dosage: unk
Indication: Foetal Exposure During Pregnancy
Possible Primidone side effects in
Reported by a physician from Hungary on 2012-03-13
Patient:
Reactions: Syndactyly, Maternal Drugs Affecting Foetus, Choanal Atresia, Patent Ductus Arteriosus, Coloboma, Microtia
Drug(s) suspected as cause:
Diazepam
Dosage: unk, transplacental
Indication: Maternal Exposure During Pregnancy
Mephenytoin (Mephenytoin)
Dosage: unk, transplacental
Indication: Maternal Exposure During Pregnancy
Primidone
Dosage: unk, transplacental
Indication: Maternal Exposure During Pregnancy
Possible Primidone side effects in
Reported by a physician from Hungary on 2012-03-13
Patient:
Reactions: Pulmonary Artery Stenosis Congenital, Maternal Drugs Affecting Foetus, Kidney Enlargement, Congenital Absence of Vertebra, Rectal Stenosis, Talipes, Microtia
Drug(s) suspected as cause:
Phenacemide (Phenacemide)
Dosage: unk, transplacental
Indication: Maternal Exposure During Pregnancy
Phenobarbital TAB
Dosage: unk, transplacental
Indication: Maternal Exposure During Pregnancy
Primidone
Dosage: unk, transplacental
Indication: Maternal Exposure During Pregnancy
Possible Primidone side effects in
Reported by a physician from Hungary on 2012-03-05
Patient:
Reactions: Syndactyly, Choanal Atresia, Patent Ductus Arteriosus, Maternal Exposure During Pregnancy, Coloboma, Microtia
Drug(s) suspected as cause:
Diazepam
Indication: Epilepsy
Mephenytoin
Indication: Epilepsy
Phenytoin
Indication: Epilepsy
Primidone
Indication: Epilepsy
Possible Primidone side effects in
Reported by a health professional (non-physician/pharmacist) from Hungary on 2012-03-05
Patient:
Reactions: Syndactyly, Choanal Atresia, Patent Ductus Arteriosus, Foetal Exposure During Pregnancy, Coloboma, Microtia
Drug(s) suspected as cause:
Diazepam
Mephenytoin
Phenytoin
Primidone
Possible Primidone side effects in
Reported by a physician from Hungary on 2012-03-05
Patient:
Reactions: Syndactyly, Choanal Atresia, Patent Ductus Arteriosus, Maternal Exposure During Pregnancy, Coloboma, Microtia
Drug(s) suspected as cause:
Diazepam
Indication: Epilepsy
Mephenytoin
Indication: Epilepsy
Phenytoin
Indication: Epilepsy
Primidone
Indication: Epilepsy
Possible Primidone side effects in female
Reported by a physician from United States on 2012-03-02
Patient: female, weighing 74.0 kg (162.8 pounds)
Reactions: Drug Ineffective, Dyskinesia, Speech Disorder, Dizziness, Coordination Abnormal, Back Pain, Ataxia, Cognitive Disorder, Amnesia, Ill-Defined Disorder, Tremor, Convulsion, Grand MAL Convulsion, Insomnia, Gait Disturbance, Asthenia, Head Titubation, Mobility Decreased
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Depakote ER
Indication: Convulsion
Start date: 2007-01-01
End date: 2010-11-01
Depakote ER
Start date: 2011-02-01
Divalproex Sodium
Indication: Convulsion
Keppra
Indication: Convulsion Prophylaxis
Start date: 2010-11-01
End date: 2011-02-01
Primidone
Administration route: Oral
Indication: Tremor
Primidone
Other drugs received by patient: Adult Aspirin LOW Strength; Calcium; Triazolam
Possible Primidone side effects in female
Reported by a physician from United States on 2012-02-29
Patient: female
Reactions: Adverse Event, Convulsion
Drug(s) suspected as cause:
Primidone
Possible Primidone side effects in female
Reported by a physician from United States on 2012-02-22
Patient: female, weighing 74.0 kg (162.8 pounds)
Reactions: Drug Ineffective, Dyskinesia, Speech Disorder, Dizziness, Coordination Abnormal, Back Pain, Ataxia, Cognitive Disorder, Amnesia, Ill-Defined Disorder, Convulsion, Tremor, Grand MAL Convulsion, Insomnia, Gait Disturbance, Asthenia, Mobility Decreased, Head Titubation
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Depakote ER
Indication: Convulsion
Start date: 2007-01-01
End date: 2010-11-01
Depakote ER
Start date: 2011-02-01
Divalproex Sodium
Indication: Convulsion
Keppra
Indication: Convulsion Prophylaxis
Start date: 2010-11-01
End date: 2011-02-01
Primidone
Administration route: Oral
Indication: Tremor
Primidone
Other drugs received by patient: Triazolam; Adult Aspirin LOW Strength; Calcium
Possible Primidone side effects in 55 year old female
Reported by a physician from Germany on 2012-02-21
Patient: 55 year old female, weighing 100.0 kg (220.0 pounds)
Reactions: Accidental Overdose
Drug(s) suspected as cause:
Carbamazepine
Dosage: total dose:2400 mg (within 12 hours)
Administration route: Oral
Primidone
Dosage: total dose:1250 mg; 250 (5 tablets within 12 hours)
Administration route: Oral
Vimpat
Dosage: total dose:800mg;200 (4 tablets within a period of 12 hours)
Administration route: Oral
Possible Primidone side effects in
Reported by a individual with unspecified qualification from Hungary on 2012-01-06
Patient:
Reactions: Atrial Septal Defect, Maternal Exposure Timing Unspecified
Drug(s) suspected as cause:
Diazepam
Indication: Epilepsy
Phenytoin
Indication: Epilepsy
Primidone
Indication: Epilepsy
Possible Primidone side effects in
Reported by a individual with unspecified qualification from Hungary on 2012-01-06
Patient:
Reactions: Spina Bifida, Patent Ductus Arteriosus, Ventricular Septal Defect, Maternal Exposure Timing Unspecified, Hypospadias
Drug(s) suspected as cause:
Diazepam
Indication: Epilepsy
Primidone
Indication: Epilepsy
Valproate Sodium
Indication: Epilepsy
Possible Primidone side effects in
Reported by a individual with unspecified qualification from Hungary on 2012-01-06
Patient:
Reactions: Cleft LIP, Syndactyly, Maternal Drugs Affecting Foetus, Cleft Palate, Patent Ductus Arteriosus, Maternal Exposure Timing Unspecified, Microtia
Drug(s) suspected as cause:
Diazepam
Indication: Epilepsy
Mephenytoin
Indication: Epilepsy
Phenytoin
Indication: Epilepsy
Primidone
Indication: Epilepsy
Possible Primidone side effects in
Reported by a individual with unspecified qualification from Hungary on 2012-01-06
Patient:
Reactions: Cleft LIP, Maternal Exposure Timing Unspecified
Drug(s) suspected as cause:
Diazepam
Indication: Epilepsy
Primidone
Indication: Epilepsy
Possible Primidone side effects in
Reported by a health professional (non-physician/pharmacist) from Hungary on 2012-01-06
Patient:
Reactions: Maternal Exposure Timing Unspecified, Congenital Cardiovascular Anomaly
Drug(s) suspected as cause:
Carbamazepine
Indication: Epilepsy
Diazepam
Indication: Epilepsy
Ethosuximide
Indication: Epilepsy
Primidone
Indication: Epilepsy
Possible Primidone side effects in
Reported by a health professional (non-physician/pharmacist) from Hungary on 2012-01-03
Patient:
Reactions: Atrial Septal Defect, Maternal Exposure Timing Unspecified
Drug(s) suspected as cause:
Diazepam
Indication: Epilepsy
Phenytoin
Indication: Epilepsy
Primidone
Indication: Epilepsy
Possible Primidone side effects in
Reported by a health professional (non-physician/pharmacist) from Hungary on 2012-01-03
Patient:
Reactions: Cleft LIP, Maternal Exposure Timing Unspecified
Drug(s) suspected as cause:
Diazepam
Indication: Epilepsy
Primidone
Indication: Epilepsy
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