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Carbatrol (Carbamazepine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Carbatrol (Carbamazepine) 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 (40)
Death (6)
Life Threatening Events (1)
Disability (4)

Reports by Reaction Type

Convulsion (12)Insomnia (8)Drug Level Below Therapeutic (4)Optic Neuritis (4)Influenza Like Illness (4)Hepatotoxicity (4)Nervousness (4)Stevens-Johnson Syndrome (4)Vomiting (4)Nausea (4)Acute Hepatic Failure (4)Feeling Abnormal (4)

Below are a few examples of reports where side effects / adverse reactions may be related to Carbatrol (Carbamazepine). For a complete list or a specific selection of reports, please use the links above.

Possible Carbatrol side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13

Patient: female, weighing 84.0 kg (184.8 pounds)

Reactions: Off Label Use, Vomiting, Hepatotoxicity, Nausea, Insomnia, Acute Hepatic Failure, Optic Neuritis

Drug(s) suspected as cause:
Carbatrol
    Dosage: 200 mg, 1x/day:qd
    Administration route: Oral
    Indication: Loss of Control of Legs
    Start date: 2006-09-01
    End date: 2008-02-20

Rebif / 05982701 /
    Dosage: 44 ?g, other (3 in 1 week)
    Indication: Multiple Sclerosis
    Start date: 2006-09-13
    End date: 2008-02-27

Other drugs received by patient: Gabapentin; Ibuprofen (Advil); Ibuprofen (Advil)



Possible Carbatrol side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-24

Patient: male

Reactions: Death, Drug Prescribing Error

Adverse event resulted in: death

Drug(s) suspected as cause:
Carbatrol



Possible Carbatrol side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-18

Patient: female, weighing 84.0 kg (184.8 pounds)

Reactions: Off Label Use, Vomiting, Hepatotoxicity, Nausea, Insomnia, Acute Hepatic Failure, Optic Neuritis

Drug(s) suspected as cause:
Rebif
    Dosage: 44 ?g, other (3 in 1 week)
    Indication: Multiple Sclerosis
    Start date: 2006-09-13
    End date: 2008-02-27

Carbatrol
    Dosage: 200 mg, 1x/day:qd
    Administration route: Oral
    Indication: Loss of Control of Legs
    Start date: 2006-09-01
    End date: 2008-02-20

Other drugs received by patient: Ibuprofen (Advil); Ibuprofen (Advil); Gabapentin



Possible Carbatrol side effects in 36 year old male

Reported by a physician from United States on 2012-07-10

Patient: 36 year old male, weighing 64.0 kg (140.8 pounds)

Reactions: Overdose, Memory Impairment

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Keppra
    Start date: 2012-06-15
    End date: 2012-06-15

Lamictal
    Start date: 2012-06-15
    End date: 2012-06-15

Synthroid
    Start date: 2012-06-15
    End date: 2012-06-15

Carbatrol
    Start date: 2012-06-15
    End date: 2012-06-15

Vimpat
    Start date: 2012-06-15
    End date: 2012-06-15

Diastat
    Start date: 2012-06-15
    End date: 2012-06-15



Possible Carbatrol side effects in female

Reported by a physician from United States on 2012-07-09

Patient: female, weighing 84.0 kg (184.8 pounds)

Reactions: Vomiting, Hepatotoxicity, Nausea, Insomnia, Acute Hepatic Failure, Optic Neuritis

Drug(s) suspected as cause:
Rebif
    Indication: Multiple Sclerosis
    Start date: 2006-09-13
    End date: 2008-02-27

Carbatrol
    Indication: Loss of Control of Legs
    Start date: 2006-09-01
    End date: 2008-02-20

Other drugs received by patient: Ibuprofen (Advil); Cisplatin; Ibuprofen (Advil)



Possible Carbatrol side effects in female

Reported by a physician from United States on 2012-06-28

Patient: female, weighing 84.0 kg (184.8 pounds)

Reactions: Vomiting, Nausea, Hepatotoxicity, Insomnia, Acute Hepatic Failure, Optic Neuritis

Drug(s) suspected as cause:
Rebif
    Indication: Multiple Sclerosis
    Start date: 2006-09-13
    End date: 2008-02-27

Carbatrol
    Indication: Loss of Control of Legs
    Start date: 2006-09-01
    End date: 2008-02-20

Other drugs received by patient: Ibuprofen (Advil); Gabapentin; Ibuprofen (Advil)



Possible Carbatrol side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-15

Patient: male, weighing 79.4 kg (174.6 pounds)

Reactions: Balance Disorder, Hypertension, Cerebrovascular Accident, Nervousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carbatrol
    Dosage: 600 mg, two 300 mg capsules 2x/day:bid
    Administration route: Oral
    Indication: Convulsion
    Start date: 2002-01-01
    End date: 2011-12-01

Carbatrol
    Dosage: 200 mg, 1x/day:qd in morning
    Administration route: Oral
    Start date: 2002-01-01
    End date: 2011-12-01

Carbamazepine
    Dosage: 200 mg, 1x/day:qd in morning
    Administration route: Oral
    Start date: 2011-12-01

Carbamazepine
    Dosage: 600 mg, two 300 mg capsules 2x/day:bid
    Administration route: Oral
    Indication: Convulsion
    Start date: 2011-12-01

Other drugs received by patient: Zolpidem; Gabapentin



Possible Carbatrol side effects in male

Reported by a physician from United States on 2012-06-12

Patient: male, weighing 81.6 kg (179.6 pounds)

Reactions: Inappropriate Schedule of Drug Administration, Adverse Event, Gait Disturbance, Atonic Seizures

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Carbatrol

Other drugs received by patient: Phenobarbital TAB; Phenobarbital TAB; Lamictal; Lamictal



Possible Carbatrol side effects in 45 year old female

Reported by a physician from United States on 2012-05-25

Patient: 45 year old female

Reactions: Product Substitution Issue, Convulsion

Drug(s) suspected as cause:
Carbatrol



Possible Carbatrol side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-25

Patient: male

Reactions: Death, Drug Prescribing Error

Adverse event resulted in: death

Drug(s) suspected as cause:
Carbatrol



Possible Carbatrol side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-16

Patient: male, weighing 81.6 kg (179.6 pounds)

Reactions: Inappropriate Schedule of Drug Administration, Adverse Event, Atonic Seizures, Gait Disturbance

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Carbatrol

Other drugs received by patient: Phenobarbital TAB; Phenobarbital TAB; Lamictal; Lamictal



Possible Carbatrol side effects in 29 year old female

Reported by a physician from United States on 2012-04-13

Patient: 29 year old female

Reactions: Electrocardiogram QT Prolonged, Sinus Tachycardia

Drug(s) suspected as cause:
Vimpat
    Administration route: Oral
    Indication: Complex Partial Seizures
    End date: 2012-02-01

Vimpat
    Administration route: Oral
    Start date: 2011-12-22

Carbatrol
    Indication: Convulsion

Other drugs received by patient: Promiseb; Oral Contraceptives; Cephalexin



Possible Carbatrol side effects in 29 year old female

Reported by a physician from United States on 2012-04-11

Patient: 29 year old female

Reactions: Sinus Tachycardia

Drug(s) suspected as cause:
Lacosamide
    Administration route: Oral
    Start date: 2011-12-22

Lacosamide
    Administration route: Oral
    Indication: Complex Partial Seizures
    End date: 2012-02-01

Carbatrol
    Indication: Convulsion

Other drugs received by patient: Cephalexin; Promiseb; Oral Contraceptives



Possible Carbatrol side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-02

Patient: male

Reactions: Toxicity To Various Agents

Drug(s) suspected as cause:
Carbatrol
    Dosage: 400 mg, daily dose
    Administration route: Oral

Carbatrol
    Dosage: 900 mg, daily dose
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Carbatrol side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-02

Patient: female

Reactions: Drug Ineffective, Impaired Work Ability, Pain, Dizziness, Somnolence

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Baclofen
    Dosage: 10 mg, unk
    Indication: Neuralgia

Amitriptyline HCL
    Dosage: 50 mg, unk
    Indication: Neuralgia

Lyrica
    Dosage: 75 mg, 3x/day
    Indication: Post Herpetic Neuralgia

Carbatrol
    Dosage: 200 mg, unk
    Indication: Neuralgia



Possible Carbatrol side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-24

Patient: female, weighing 68.0 kg (149.7 pounds)

Reactions: Drug Level Above Therapeutic, Drug Level Below Therapeutic, Fatigue, Balance Disorder, Headache, Feeling Abnormal, Convulsion

Drug(s) suspected as cause:
Carbatrol
    Dosage: 200 mg, other (2 capsules in am and unknown amount of capsules in pm)
    Administration route: Oral
    Indication: Convulsion

Carbatrol
    Dosage: 200 mg, other (1 capsule in am and 2 capsules in pm)
    Administration route: Oral

Other drugs received by patient: Vimpat



Possible Carbatrol side effects in 27 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-16

Patient: 27 year old female, weighing 54.4 kg (119.7 pounds)

Reactions: Drug Dose Omission, Agitation, Obsessive-Compulsive Disorder, Hypomania, Mania, Palpitations, Chest Pain, Heart Rate Irregular, Muscle Spasms, Nervousness, Anxiety Disorder, Abnormal Behaviour, Amnesia, Psychotic Disorder, Heart Rate Increased, Insomnia, Feeling Abnormal, Psychosomatic Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Seroquel
    Administration route: Oral
    Start date: 2011-08-03

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Start date: 2011-08-03

Lamictal
    Administration route: Oral
    Start date: 2011-09-01

Carbatrol
    Start date: 2011-07-18

Seroquel
    Administration route: Oral
    Start date: 2011-07-18

Seroquel
    Administration route: Oral

Lamictal
    Administration route: Oral

Seroquel
    Administration route: Oral
    Indication: Bipolar I Disorder
    Start date: 2011-07-18

Seroquel
    Administration route: Oral

Lamictal
    Administration route: Oral

Lamictal
    Dosage: 300 mgs am 100 mgs hs

Seroquel
    Administration route: Oral
    Start date: 2011-08-03

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral

Lamictal
    Dosage: 300 mgs am 100 mgs hs

Seroquel
    Administration route: Oral
    Start date: 2011-08-03

Seroquel
    Administration route: Oral

Lamictal
    Administration route: Oral
    Indication: Mood Swings

Lamictal
    Administration route: Oral
    Start date: 2011-09-01

Seroquel
    Administration route: Oral
    Start date: 2011-08-03

Seroquel
    Administration route: Oral
    Start date: 2011-08-03

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Start date: 2011-08-03

Seroquel
    Dosage: decrease dose to less than 650 mg
    Administration route: Oral

Seroquel
    Dosage: decrease dose to less than 650 mg
    Administration route: Oral

Seroquel
    Administration route: Oral
    Start date: 2011-08-03

Seroquel
    Administration route: Oral

Lamictal
    Administration route: Oral
    Indication: Affective Disorder

Other drugs received by patient: Ativan; Ativan; Ativan; Ativan; Ativan; Ativan



Possible Carbatrol side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-15

Patient: female

Reactions: Drug Ineffective, Impaired Work Ability, Pain, Dizziness, Somnolence

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Lyrica
    Dosage: 75 mg, 3x/day
    Indication: Post Herpetic Neuralgia

Carbatrol
    Dosage: 200 mg, unk
    Indication: Neuralgia

Baclofen
    Dosage: 10 mg, unk
    Indication: Neuralgia

Amitriptyline HCL
    Dosage: 50 mg, unk
    Indication: Neuralgia



Possible Carbatrol side effects in male

Reported by a physician from United States on 2012-02-01

Patient: male, weighing 136.5 kg (300.3 pounds)

Reactions: Overdose, Choking, Acute Respiratory Distress Syndrome

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Carbatrol
    Dosage: 400 mg (2-200 mg capsules at bedtime daily), 1x/day:qd
    Administration route: Oral

Carbatrol
    Dosage: 600 mg (3-200 mg capsules in the morning daily), 1x/day:qd
    Administration route: Oral
    Indication: Convulsion

Carbatrol
    Dosage: 400 mg (2-200 mg capsules at noon daily), 1x/day:qd
    Administration route: Oral

Other drugs received by patient: Catapres / 00171101 /; Felbatol; Vimpat; Vimpat



Possible Carbatrol side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-01

Patient: male

Reactions: Product Substitution Issue, Convulsion

Drug(s) suspected as cause:
Carbatrol



Possible Carbatrol side effects in female

Reported by a consumer/non-health professional from United States on 2012-01-18

Patient: female, weighing 52.2 kg (114.7 pounds)

Reactions: Off Label Use, Sick Sinus Syndrome, Concussion, Diabetes Mellitus, Blood Cholesterol Increased, Hypertension, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carbatrol
    Dosage: 400 mg, 1x/day:pm
    Administration route: Oral
    Start date: 2012-01-07

Carbatrol
    Dosage: 400 mg, 1x/day:pm
    Administration route: Oral
    Start date: 1995-01-01
    End date: 2011-12-01

Carbatrol
    Dosage: 300 mg, 1x/day:am
    Administration route: Oral
    Start date: 2012-01-07

Carbatrol
    Dosage: 300 mg, 1x/day:am
    Administration route: Oral
    Indication: Hydrocephalus
    Start date: 1995-01-01
    End date: 2011-12-01



Possible Carbatrol side effects in 27 year old female

Reported by a consumer/non-health professional from United States on 2012-01-12

Patient: 27 year old female, weighing 55.8 kg (122.8 pounds)

Reactions: Agitation, Drug Dose Omission, Hypomania, Thirst, Mania, Palpitations, Chest Pain, Heart Rate Irregular, Muscle Spasms, Nervousness, Rash Generalised, Abnormal Behaviour, Rash, Amnesia, Anxiety, Insomnia, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Seroquel
    Administration route: Oral
    Start date: 2011-08-03

Seroquel
    Administration route: Oral

Lamictal
    Dosage: 300 mgs am 100 mgs hs

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Start date: 2011-08-03

Seroquel
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-07-18

Seroquel
    Administration route: Oral
    Indication: Bipolar I Disorder
    Start date: 2011-07-18

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Start date: 2011-08-03

Seroquel
    Administration route: Oral
    Start date: 2011-08-03

Seroquel
    Administration route: Oral
    Start date: 2011-08-03

Seroquel
    Administration route: Oral

Lamictal
    Administration route: Oral
    Indication: Mood Swings

Carbatrol
    Start date: 2011-07-18

Seroquel
    Administration route: Oral
    Start date: 2011-08-03

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral

Lamictal
    Administration route: Oral

Seroquel
    Administration route: Oral

Other drugs received by patient: Lorazepam; Ativan; Ativan



Possible Carbatrol side effects in 6 year old male

Reported by a individual with unspecified qualification from United States on 2012-01-06

Patient: 6 year old male

Reactions: Pulmonary Haemorrhage, Epistaxis

Adverse event resulted in: death

Drug(s) suspected as cause:
Topamax

Keppra

Abilify
    Dosage: 1 cc in morning and 2 cc at night

Diastat

Carbatrol
    Dosage: 300 mg daily in morning and 400 mg daily at night



Possible Carbatrol side effects in female

Reported by a physician from United States on 2011-12-30

Patient: female, weighing 99.8 kg (219.5 pounds)

Reactions: Insomnia, Paralysis, Hallucination, Drug Chemical Incompatibility, Cardiac Failure Congestive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amoxicillin
    Dosage: 500 mg, 1x/day:qd
    Administration route: Oral
    Indication: Pain in JAW
    Start date: 2011-08-01
    End date: 2011-08-01

Carbatrol
    Dosage: 100 mg, 6 times daily
    Administration route: Oral
    Indication: Trigeminal Neuralgia
    Start date: 2011-08-01

Other drugs received by patient: Carvedilol; Uloric; Pravastatin; Omeprazole; Losartan Potassium; Mucinex



Possible Carbatrol side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-30

Patient: female, weighing 45.4 kg (99.8 pounds)

Reactions: Grand MAL Convulsion, Speech Disorder, Depression, Gait Disturbance, Toxicity To Various Agents, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carbatrol



Possible Carbatrol side effects in 50 year old male

Reported by a consumer/non-health professional from United States on 2011-12-30

Patient: 50 year old male

Reactions: Brain Neoplasm

Adverse event resulted in: death

Drug(s) suspected as cause:
Carbatrol



Possible Carbatrol side effects in male

Reported by a consumer/non-health professional from United States on 2011-12-19

Patient: male, weighing 97.5 kg (214.5 pounds)

Reactions: Product Quality Issue, Convulsion

Drug(s) suspected as cause:
Carbatrol

Other drugs received by patient: Zonegran; Effexor



Possible Carbatrol side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-13

Patient:

Reactions: Neural Tube Defect, Congenital Oral Malformation, Congenital Anomaly, Congenital Cardiovascular Anomaly

Drug(s) suspected as cause:
Carbatrol



Possible Carbatrol side effects in 27 year old female

Reported by a consumer/non-health professional from United States on 2011-12-07

Patient: 27 year old female, weighing 68.0 kg (149.6 pounds)

Reactions: Drug Dose Omission, Agitation, Rash Generalised, Abnormal Behaviour, Rash, Hypomania, Thirst, Amnesia, Mania, Anxiety, Insomnia, Heart Rate Irregular, Feeling Abnormal, Muscle Spasms, Nervousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Start date: 2011-08-03

Seroquel
    Administration route: Oral

Lamictal
    Administration route: Oral
    Indication: Mood Swings

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-07-18

Seroquel
    Administration route: Oral
    Start date: 2011-08-03

Seroquel
    Administration route: Oral
    Indication: Bipolar I Disorder
    Start date: 2011-07-18

Seroquel
    Administration route: Oral
    Start date: 2011-08-03

Seroquel
    Administration route: Oral
    Start date: 2011-08-03

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral

Lamictal
    Administration route: Oral

Carbatrol
    Start date: 2011-07-18

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Start date: 2011-08-03

Seroquel
    Administration route: Oral
    Start date: 2011-08-03

Other drugs received by patient: Ativan; Lorazepam



Possible Carbatrol side effects in male

Reported by a consumer/non-health professional from United States on 2011-12-05

Patient: male, weighing 81.6 kg (179.6 pounds)

Reactions: Drug Level Below Therapeutic, Stevens-Johnson Syndrome, Convulsion, Influenza Like Illness

Drug(s) suspected as cause:
Dilantin
    Dosage: 130 mg, 2x/day:bid(100mg and 30mg morning and afternoon)
    Administration route: Oral
    Indication: Epilepsy
    Start date: 1996-04-01

Carbatrol
    Dosage: unk, unknown
    Administration route: Oral
    Indication: Epilepsy

Dilantin
    Dosage: 160 mg, (1x/day:qdin evening 100mg and two 30 mg)
    Administration route: Oral
    Start date: 1996-04-01

Dilantin
    Dosage: unk, unknown
    Administration route: Oral

Other drugs received by patient: Multi-Vitamins

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