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Tegretol-XR (Carbamazepine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Tegretol-XR (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 (119)
Death (9)
Life Threatening Events (6)
Disability (7)

Reports by Reaction Type

Convulsion (36)Fall (23)Dizziness (11)Drug Ineffective (10)Malaise (10)Dyspnoea (10)Epilepsy (9)Vomiting (8)Anxiety (8)Somnolence (7)Back Pain (7)Pain in Extremity (7)

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

Possible Tegretol-XR side effects in female

Reported by a consumer/non-health professional from United Kingdom on 2012-08-23

Patient: female, weighing 49.0 kg (107.8 pounds)

Reactions: Dysgeusia, Malaise, Drug Level Increased, Nausea, Epilepsy

Drug(s) suspected as cause:
Tegretol-XR
    Dosage: 600 mg, unk
    Administration route: Oral

Tegretol-XR
    Dosage: 400 mg, bid
    Administration route: Oral

Other drugs received by patient: Alendronate Sodium; Atenolol; Calcichew D3; Levetiracetam; Perindopril Erbumine



Possible Tegretol-XR side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Migraine, Overdose, Malaise, Drug Ineffective, Intraocular Pressure Increased, Depression, Drug Level Decreased, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carbamazepine

Keppra
    Dosage: 1000 mg, unk
    Indication: Migraine

Keppra
    Dosage: 200 mg, unk

Tegretol-XR
    Dosage: 1200 mg, unk

Tegretol-XR
    Dosage: 1400 mg (200mg 7 times per day)

Other drugs received by patient: Simvastatin



Possible Tegretol-XR side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: female

Reactions: Migraine, Malaise, Drug Ineffective, Intraocular Pressure Increased, Depression, Drug Level Decreased, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carbamazepine

Tegretol-XR
    Dosage: 1200 mg, unk

Other drugs received by patient: Simvastatin



Possible Tegretol-XR side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: male

Reactions: Asthma, Learning Disability

Drug(s) suspected as cause:
Tegretol-XR
    Dosage: 1200 mg, unk

Tegretol-XR
    Dosage: 1200 mg, unk



Possible Tegretol-XR side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-27

Patient: female

Reactions: Nausea, Head Injury, Thirst, Joint Injury, Fall, Dysstasia, Balance Disorder, Dizziness, Vision Blurred, Lethargy

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Tegretol-XR



Possible Tegretol-XR side effects in male

Reported by a physician from United States on 2012-07-26

Patient: male

Reactions: Limb Crushing Injury, Pain in Extremity, Laceration, Fall, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tegretol
    Dosage: 200 mg, unk
    Indication: Convulsion

Tegretol

Tegretol-XR
    Dosage: 200 mg 5 times daily
    Administration route: Oral
    Indication: Convulsion

Other drugs received by patient: Tramadol Hydrochloride



Possible Tegretol-XR side effects in female

Reported by a pharmacist from United Kingdom on 2012-07-18

Patient: female

Reactions: Back Pain, Oedema Peripheral, Epilepsy

Drug(s) suspected as cause:
Tegretol-XR



Possible Tegretol-XR side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-16

Patient: male

Reactions: Limb Crushing Injury, Pain in Extremity, Laceration, Fall, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tegretol
    Dosage: 200 mg, unk
    Indication: Convulsion

Tegretol

Tegretol-XR
    Dosage: 200 mg 5 times daily
    Administration route: Oral
    Indication: Convulsion



Possible Tegretol-XR side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-11

Patient: male

Reactions: Limb Crushing Injury, Pain in Extremity, Laceration, Fall, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tegretol-XR



Possible Tegretol-XR side effects in 50 year old male

Reported by a consumer/non-health professional from United States on 2012-07-05

Patient: 50 year old male, weighing 83.0 kg (182.6 pounds)

Reactions: Diarrhoea, Drug Intolerance, Crohn's Disease, Intestinal Obstruction, Constipation, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carbamazepine

Tegretol-XR
    Dosage: 400 mg, bid
    Indication: Convulsion
    Start date: 2012-04-06
    End date: 2012-05-14

Other drugs received by patient: Cyanocobalamin; Allegra; Acidophilus; Prevacid; Pentasa; Vitamin B-12; Imitrex; Desonide; Sodium Chloride; Sucrose; Ergocalciferol; Triamcinolone Acetonide; Hydrocortisone; Humira; Keppra; Aspirin; Imodium; Bactrim DS



Possible Tegretol-XR side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-07-03

Patient: female

Reactions: Pulmonary Oedema, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tegretol-XR

Other drugs received by patient: Clonazepam; Isosorbide Mononitrate; Amlodipine Besylate; Clonidine Hydrochloride; Clorana; Lasix; Ovestrion; Aspirin; Carvedilol; Clopidogrel; Nootropil; Atorvastatin



Possible Tegretol-XR side effects in 50 year old male

Reported by a consumer/non-health professional from United States on 2012-07-02

Patient: 50 year old male, weighing 83.0 kg (182.6 pounds)

Reactions: Diarrhoea, Crohn's Disease, Drug Intolerance, Intestinal Obstruction, Constipation, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carbamazepine

Tegretol-XR
    Dosage: 400 mg, bid
    Indication: Convulsion
    Start date: 2012-04-06
    End date: 2012-05-14

Other drugs received by patient: Pentasa; Humira; Acidophilus; Prevacid; Aspirin; Vitamin B-12; Sodium Chloride; Bactrim DS; Cyanocobalamin; Keppra; Desonide; Hydrocortisone; Imodium; Sucrose; Triamcinolone Acetonide; Allegra; Imitrex; Ergocalciferol



Possible Tegretol-XR side effects in male

Reported by a physician from United States on 2012-06-29

Patient: male

Reactions: Vomiting, Fall, Convulsion, Anxiety, Malaise, Cyanosis, Dizziness, Learning Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lamictal
    Dosage: 300 mg, bid
    Administration route: Oral
    Indication: Epilepsy

Lamictal
    Dosage: unk ukn, unk
    Administration route: Oral

Tegretol-XR
    Dosage: 600 mg in morning and 400 mg in evening
    Start date: 2011-11-01

Vimpat
    Dosage: unk ukn, unk

Zoloft
    Dosage: unk ukn, unk

Other drugs received by patient: Sertraline Hydrochloride



Possible Tegretol-XR side effects in male

Reported by a consumer/non-health professional from Mexico on 2012-06-29

Patient: male

Reactions: Fall, Aggression

Drug(s) suspected as cause:
Tegretol-XR

Other drugs received by patient: Symbyax; Levetiracetam; Phenobarbital TAB



Possible Tegretol-XR side effects in 37 year old male

Reported by a pharmacist from Portugal on 2012-06-27

Patient: 37 year old male

Reactions: Blindness

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Tegretol-XR



Possible Tegretol-XR side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-06-25

Patient: male

Reactions: Hepatic Steatosis

Drug(s) suspected as cause:
Tegretol-XR



Possible Tegretol-XR side effects in 92 year old female

Reported by a consumer/non-health professional from Brazil on 2012-06-18

Patient: 92 year old female

Reactions: Vomiting, Ageusia, Trigeminal Neuralgia, Dementia Alzheimer's Type, Blood Pressure Abnormal, Infantile Spitting UP

Drug(s) suspected as cause:
Tegretol-XR
    Dosage: 3 df, tegretol cr 400mg, daily
    Indication: Trigeminal Neuralgia

Tegretol-XR
    Dosage: 3 df, tegretol cr 200mg q8h



Possible Tegretol-XR side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-06-18

Patient: female

Reactions: Syncope, Drug Ineffective, Cerebrovascular Accident, Epilepsy, Convulsion, Deep Vein Thrombosis

Adverse event resulted in: hospitalization

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

Tegretol-XR
    Dosage: 3.5 df, daily

Tegretol-XR
    Dosage: 3 df, daily
    Indication: Epilepsy
    Start date: 2011-11-01

Tegretol-XR
    Dosage: 0.5 df, daily

Other drugs received by patient: Domperidone; Pantoprazole; Sertraline Hydrochloride; Clobazam; Alprazolam



Possible Tegretol-XR side effects in male

Reported by a consumer/non-health professional from Mexico on 2012-06-06

Patient: male

Reactions: Brain Neoplasm

Drug(s) suspected as cause:
Tegretol-XR

Other drugs received by patient: Serecek



Possible Tegretol-XR side effects in 50 year old male

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

Patient: 50 year old male, weighing 83.0 kg (182.6 pounds)

Reactions: Diarrhoea, Drug Intolerance, Crohn's Disease, Intestinal Obstruction, Constipation, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carbamazepine

Tegretol-XR
    Dosage: 400 mg, bid
    Indication: Convulsion
    Start date: 2012-04-06
    End date: 2012-05-14

Other drugs received by patient: Aspirin; Ergocalciferol; Sodium Chloride; Humira; Cyanocobalamin; Bactrim DS; Prevacid; Triamcinolone Acetonide; Acidophilus; Imodium; Sucrose; Keppra; Pentasa; Imitrex; Hydrocortisone; Desonide; Allegra; Vitamin B-12



Possible Tegretol-XR side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-04

Patient: female, weighing 52.7 kg (116.0 pounds)

Reactions: Anxiety, Abdominal Pain, Back Pain, Pharyngeal Oedema, Dyspnoea, Pain in Extremity, Chest Pain, Throat Tightness

Drug(s) suspected as cause:
Tegretol-XR
    Dosage: 100 mg, bid
    Administration route: Oral
    Start date: 2012-02-23
    End date: 2012-02-24

Tegretol-XR
    Dosage: 100 mg, qd
    Administration route: Oral
    Start date: 2012-02-23
    End date: 2012-02-24

Other drugs received by patient: Relpax; Vitamin D; Nortriptyline Hydrochloride; Maxalt-MLT; Probiotics; Levsin PB; Zofran; Vitamin B-12



Possible Tegretol-XR side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-31

Patient: male

Reactions: Cerebrovascular Accident, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tegretol-XR



Possible Tegretol-XR side effects in female

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-05-31

Patient: female, weighing 75.0 kg (165.0 pounds)

Reactions: Daydreaming, Disturbance in Attention, Mental Retardation, Somnolence, Aggression

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Depakene
    Dosage: 600-750 mg
    Indication: Epilepsy
    Start date: 1975-03-01

Lamictal
    Dosage: 75-100 mg
    Indication: Epilepsy
    Start date: 1975-03-01

Tegretol-XR
    Dosage: 100-200 mg
    Indication: Epilepsy
    Start date: 1975-03-01

Other drugs received by patient: Diazepam; Transipeg; Naproxen



Possible Tegretol-XR side effects in female

Reported by a consumer/non-health professional from Netherlands on 2012-05-30

Patient: female, weighing 75.0 kg (165.0 pounds)

Reactions: Disturbance in Attention, Somnolence, Aggression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Indication: Epilepsy
    Start date: 1975-03-01

Lamictal
    Administration route: Oral
    Indication: Epilepsy
    Start date: 1975-03-01

Tegretol-XR
    Administration route: Oral
    Indication: Epilepsy
    Start date: 1975-03-01

Other drugs received by patient: Diazepam; Transipeg; Naproxen



Possible Tegretol-XR side effects in female

Reported by a physician from United States on 2012-05-28

Patient: female

Reactions: Anxiety, Abdominal Pain, Back Pain, Dyspnoea, Pharyngeal Oedema, Pain in Extremity, Chest Pain, Throat Tightness

Drug(s) suspected as cause:
Tegretol-XR
    Dosage: 100 mg, qd
    Administration route: Oral

Tegretol-XR
    Dosage: 100 mg, bid
    Administration route: Oral
    Start date: 2012-02-23
    End date: 2012-02-24

Other drugs received by patient: Nortriptyline Hydrochloride; Maxalt-MLT; Vitamin D; Probiotics; Levsin PB; Vitamin B-12; Relpax; Zofran



Possible Tegretol-XR side effects in female

Reported by a pharmacist from Germany on 2012-05-24

Patient: female, weighing 62.0 kg (136.4 pounds)

Reactions: Tinnitus, Lymphadenopathy, Vitamin B12 Decreased, Middle Ear Effusion, Paraesthesia, Nephrolithiasis, Mania, Hearing Impaired, Depression, Bone Density Decreased, Melanocytic Naevus, Sinusitis

Drug(s) suspected as cause:
Tegretol-XR
    Dosage: 2000 mg, daily
    Administration route: Oral
    Indication: Epilepsy
    Start date: 1992-11-01

Tegretol-XR
    Dosage: 300 mg, daily
    Administration route: Oral
    Start date: 2012-01-01

Other drugs received by patient: Keppra



Possible Tegretol-XR side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-05-24

Patient: female, weighing 60.0 kg (132.0 pounds)

Reactions: Drug Ineffective, Muscular Weakness, Skin Hyperpigmentation, Somnolence, Paraesthesia, Diplopia, Joint Swelling, Balance Disorder, Oedema Peripheral, Petit MAL Epilepsy, Dizziness, Memory Impairment

Drug(s) suspected as cause:
Tegretol-XR
    Dosage: 400 mg, q8h
    Administration route: Oral

Tegretol-XR
    Dosage: 200 mg, unk
    Administration route: Oral
    Indication: Petit MAL Epilepsy
    Start date: 1998-01-01

Tegretol-XR
    Dosage: 1300 mg/ day
    Administration route: Oral

Other drugs received by patient: Depakote; Phenobarbital TAB



Possible Tegretol-XR side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-05-22

Patient: male

Reactions: Vomiting, Lung Neoplasm, Mouth Injury, Local Swelling, Neck Mass, Oral Neoplasm, Cerebrovascular Accident, Convulsion, Haemoglobin Decreased, Platelet Count Decreased, Tongue Neoplasm

Drug(s) suspected as cause:
Carbamazepine
    Dosage: 400 mg

Phenobarbital TAB
    Dosage: unk

Phenytoin
    Dosage: 100 mg

Tegretol-XR
    Dosage: 400 mg
    Administration route: Oral
    Indication: Convulsion



Possible Tegretol-XR side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-22

Patient: female

Reactions: Confusional State, Lymphocyte Percentage Decreased, Abasia, Headache, Oropharyngeal Pain, Somnolence, Fall, Myalgia, Fatigue, DRY Mouth, Dizziness, Drug Dispensing Error, Decreased Appetite, White Blood Cell Count Increased, Blood Pressure Increased, Scratch, Neutrophil Percentage Increased, Neutrophil Count Increased, Dyspnoea, Nausea, Loss of Control of Legs, Posture Abnormal, Rash, Convulsion, Irritability, Eye Injury, Limb Injury, Vision Blurred, Gait Disturbance

Drug(s) suspected as cause:
Tegretol
    Dosage: 2 df, unk
    Indication: Convulsion

Tegretol-XR
    Dosage: 2 df, unk
    Indication: Convulsion



Possible Tegretol-XR side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-21

Patient: male

Reactions: Drug Ineffective, Convulsion

Drug(s) suspected as cause:
Carbamazepine
    Dosage: unk

Tegretol-XR
    Dosage: unk ukn, unk
    Administration route: Oral

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