DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Primidone (Primidone) - Side Effect Reports to FDA

 
 



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: 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 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 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 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

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: 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 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 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



Possible Primidone side effects in

Reported by a individual with unspecified qualification from Hungary on 2012-01-03

Patient:

Reactions: Spina Bifida, Patent Ductus Arteriosus, Ventricular Septal Defect, Hypospadias, Maternal Exposure Timing Unspecified

Drug(s) suspected as cause:
Diazepam
    Indication: Epilepsy

Primidone
    Indication: Epilepsy

Valproate Sodium
    Indication: Epilepsy

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014