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Lamotrigine (Lamotrigine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Lamotrigine 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 (1709)
Death (267)
Life Threatening Events (74)
Disability (43)

Reports by Reaction Type

Maternal Exposure During Pregnancy (190)Convulsion (184)Rash (109)Maternal Drugs Affecting Foetus (106)Completed Suicide (105)Toxicity To Various Agents (96)Drug Ineffective (86)Drug Rash With Eosinophilia and Systemic Symptoms (82)Haemoglobin Decreased (82)Foetal Exposure During Pregnancy (76)Atrial Septal Defect (75)Pyrexia (67)

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

Possible Lamotrigine side effects in 41 year old female

Reported by a physician from United States on 2012-08-27

Patient: 41 year old female

Reactions: Overdose

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lamotrigine

Other drugs received by patient: Mirtazapine; Clonazepam



Possible Lamotrigine side effects in 48 year old female

Reported by a physician from United States on 2012-08-24

Patient: 48 year old female, weighing 104.3 kg (229.5 pounds)

Reactions: Pain, Chills, Rash, Influenza Like Illness

Drug(s) suspected as cause:
Lamotrigine



Possible Lamotrigine side effects in 19 year old male

Reported by a individual with unspecified qualification from Denmark on 2012-08-24

Patient: 19 year old male

Reactions: Intentional Overdose, Ventricular Tachycardia, Serotonin Syndrome

Drug(s) suspected as cause:
Citalopram Hydrobromide

Lamotrigine

Lorazepam

Aripiprazole



Possible Lamotrigine side effects in 19 year old male

Reported by a physician from United States on 2012-08-23

Patient: 19 year old male

Reactions: Intentional Overdose, Electrocardiogram QRS Complex Prolonged, Ventricular Tachycardia, Bundle Branch Block Right, Serotonin Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lamotrigine
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Citalopram Hydrobromide
    Dosage: large dose
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Lamotrigine side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from Poland on 2012-08-23

Patient: 30 year old female

Reactions: Psychomotor Hyperactivity, Drug Effect Decreased, Vomiting, Abnormal Behaviour, Drug Interaction, Orthostatic Hypotension, Mucosal Dryness, Constipation, Disease Progression, Diplopia, Weight Increased, Oedema, Dizziness

Drug(s) suspected as cause:
Lamotrigine
    Indication: Post-Traumatic Epilepsy

Gabapentin
    Indication: Post-Traumatic Epilepsy

Other drugs received by patient possibly interacting with the suspect drug:
Oxcarbazepine
    Dosage: gradually increased to 1200 mg/day

Cabergoline
    Indication: Prolactinoma

Clarithromycin
    Indication: Respiratory Tract Infection

Ketoconazole
    Indication: Vulvovaginal Mycotic Infection

Oxcarbazepine
    Dosage: 600mg
    Indication: Post-Traumatic Epilepsy

Bromocriptine Mesylate
    Dosage: increased to target dose of 7.5mg daily
    Indication: Prolactinoma



Possible Lamotrigine side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from Poland on 2012-08-23

Patient: 30 year old female

Reactions: Drug Effect Decreased, Vomiting, Psychomotor Hyperactivity, Abnormal Behaviour, Drug Interaction, Orthostatic Hypotension, Mucosal Dryness, Constipation, Disease Progression, Diplopia, Weight Increased, Dizziness, Oedema

Drug(s) suspected as cause:
Gabapentin
    Indication: Post-Traumatic Epilepsy

Lamotrigine
    Indication: Post-Traumatic Epilepsy

Other drugs received by patient possibly interacting with the suspect drug:
Bromocriptine Mesylate
    Dosage: increased to target dose of 7.5mg daily
    Indication: Prolactinoma

Cabergoline
    Indication: Prolactinoma

Ketoconazole
    Indication: Vulvovaginal Mycotic Infection

Oxcarbazepine
    Dosage: 600mg
    Indication: Post-Traumatic Epilepsy

Oxcarbazepine
    Dosage: gradually increased to 1200 mg/day

Clarithromycin
    Indication: Respiratory Tract Infection



Possible Lamotrigine side effects in 90 year old male

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

Patient: 90 year old male

Reactions: Off Label Use, Anger, Gait Disturbance

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Lamotrigine



Possible Lamotrigine side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from Poland on 2012-08-23

Patient: 30 year old female

Reactions: Drug Effect Decreased, Vomiting, Psychomotor Hyperactivity, Abnormal Behaviour, Orthostatic Hypotension, Drug Interaction, Mucosal Dryness, Constipation, Disease Progression, Diplopia, Weight Increased, Dizziness, Oedema

Drug(s) suspected as cause:
Lamotrigine
    Indication: Post-Traumatic Epilepsy

Gabapentin
    Indication: Post-Traumatic Epilepsy

Other drugs received by patient possibly interacting with the suspect drug:
Oxcarbazepine
    Dosage: 600mg
    Indication: Post-Traumatic Epilepsy

Bromocriptine Mesylate
    Dosage: increased to target dose of 7.5mg daily
    Indication: Prolactinoma

Ketoconazole
    Indication: Vulvovaginal Mycotic Infection

Oxcarbazepine
    Dosage: gradually increased to 1200 mg/day

Cabergoline
    Indication: Prolactinoma

Clarithromycin
    Indication: Respiratory Tract Infection



Possible Lamotrigine side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from Poland on 2012-08-23

Patient: 30 year old female

Reactions: Drug Effect Decreased, Vomiting, Psychomotor Hyperactivity, Orthostatic Hypotension, Abnormal Behaviour, Drug Interaction, Mucosal Dryness, Constipation, Disease Progression, Diplopia, Weight Increased, Dizziness, Oedema

Drug(s) suspected as cause:
Lamotrigine
    Indication: Post-Traumatic Epilepsy

Gabapentin
    Indication: Post-Traumatic Epilepsy

Other drugs received by patient possibly interacting with the suspect drug:
Clarithromycin
    Indication: Respiratory Tract Infection

Cabergoline
    Indication: Prolactinoma

Ketoconazole
    Indication: Vulvovaginal Mycotic Infection

Oxcarbazepine
    Dosage: gradually increased to 1200 mg/day

Bromocriptine Mesylate
    Dosage: increased to target dose of 7.5mg daily
    Indication: Prolactinoma

Oxcarbazepine
    Dosage: 600mg
    Indication: Post-Traumatic Epilepsy



Possible Lamotrigine side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from Poland on 2012-08-23

Patient: 30 year old female

Reactions: Vomiting, Drug Effect Decreased, Psychomotor Hyperactivity, Orthostatic Hypotension, Drug Interaction, Abnormal Behaviour, Mucosal Dryness, Constipation, Disease Progression, Diplopia, Weight Increased, Dizziness, Oedema

Drug(s) suspected as cause:
Gabapentin
    Indication: Post-Traumatic Epilepsy

Lamotrigine
    Indication: Post-Traumatic Epilepsy

Other drugs received by patient possibly interacting with the suspect drug:
Bromocriptine Mesylate
    Dosage: increased to target dose of 7.5mg daily
    Indication: Prolactinoma

Oxcarbazepine
    Dosage: 600mg
    Indication: Post-Traumatic Epilepsy

Ketoconazole
    Indication: Vulvovaginal Mycotic Infection

Oxcarbazepine
    Dosage: gradually increased to 1200 mg/day

Cabergoline
    Indication: Prolactinoma

Clarithromycin
    Indication: Respiratory Tract Infection



Possible Lamotrigine side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from Poland on 2012-08-23

Patient: 30 year old female

Reactions: Psychomotor Hyperactivity, Vomiting, Drug Effect Decreased, Body Mass Index Increased, Drug Interaction, Orthostatic Hypotension, Abnormal Behaviour, Condition Aggravated, Mucosal Dryness, Constipation, Menstrual Disorder, Diplopia, Oedema, Dizziness

Drug(s) suspected as cause:
Clarithromycin
    Indication: Respiratory Tract Infection

Gabapentin
    Indication: Post-Traumatic Epilepsy

Ketoconazole
    Dosage: 7 days
    Indication: Vaginal Lesion

Lamotrigine
    Indication: Post-Traumatic Epilepsy

Other drugs received by patient possibly interacting with the suspect drug:
Bromocriptine Mesylate
    Dosage: 7.5 mg/day
    Indication: Prolactinoma

Oxcarbazepine
    Dosage: 1200 mg/day

Oxcarbazepine
    Dosage: 600 mg
    Indication: Post-Traumatic Epilepsy

Bromocriptine Mesylate
    Dosage: 15 mg

Bromocriptine Mesylate
    Dosage: 20 mg

Cabergoline
    Dosage: 0.25 mg, 2/week
    Indication: Prolactinoma

Cabergoline
    Dosage: 2 mg/ week

Other drugs received by patient: Quinagolide



Possible Lamotrigine side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from Poland on 2012-08-23

Patient: 30 year old female

Reactions: Vomiting, Drug Effect Decreased, Psychomotor Hyperactivity, Abnormal Behaviour, Orthostatic Hypotension, Drug Interaction, Mucosal Dryness, Constipation, Disease Progression, Weight Increased, Diplopia, Oedema, Dizziness

Drug(s) suspected as cause:
Lamotrigine
    Indication: Post-Traumatic Epilepsy

Gabapentin
    Indication: Post-Traumatic Epilepsy

Other drugs received by patient possibly interacting with the suspect drug:
Cabergoline
    Indication: Prolactinoma

Clarithromycin
    Indication: Respiratory Tract Infection

Bromocriptine Mesylate
    Dosage: increased to target dose of 7.5mg daily
    Indication: Prolactinoma

Oxcarbazepine
    Dosage: 600mg
    Indication: Post-Traumatic Epilepsy

Oxcarbazepine
    Dosage: gradually increased to 1200 mg/day

Ketoconazole
    Indication: Vulvovaginal Mycotic Infection



Possible Lamotrigine side effects in female

Reported by a physician from United States on 2012-08-22

Patient: female, weighing 90.7 kg (199.6 pounds)

Reactions: Irritability, Product Substitution Issue, Mood Altered, Drug Ineffective, Frustration

Drug(s) suspected as cause:
Lamotrigine



Possible Lamotrigine side effects in 33 year old female

Reported by a physician from United Kingdom on 2012-08-22

Patient: 33 year old female, weighing 60.0 kg (132.0 pounds)

Reactions: Angioedema, Urticaria, Condition Aggravated, Tenderness, Deformity, Stress

Drug(s) suspected as cause:
Lamotrigine

Other drugs received by patient: Citalopram Hydrobromide



Possible Lamotrigine side effects in 47 year old female

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

Patient: 47 year old female, weighing 90.2 kg (198.5 pounds)

Reactions: Irritability, Weight Decreased, Panic Attack, Drug Ineffective, Depressed Mood, Haemorrhoidal Haemorrhage, Medication Residue

Drug(s) suspected as cause:
Xanax
    Dosage: unk, 2x/day
    Administration route: Oral
    Indication: Anxiety
    Start date: 2011-08-01

Abilify
    Dosage: unk

Pristiq
    Dosage: 50 mg, 1x/day (qam)
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2012-04-13
    End date: 2012-06-13

Lamotrigine
    Dosage: unk

Xanax
    Dosage: 1 mg, 3x/day
    Administration route: Oral

Pristiq
    Indication: Major Depression

Pristiq
    Indication: Depression

Other drugs received by patient: Hydrocodon



Possible Lamotrigine side effects in 59 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-21

Patient: 59 year old female, weighing 83.5 kg (183.7 pounds)

Reactions: C-Reactive Protein Increased, Drug Interaction, Muscular Weakness, Rash Maculo-Papular, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lamotrigine
    Dosage: 50 mg, bid
    Administration route: Oral
    Indication: Bipolar Disorder

Depakote
    Dosage: 750 mg, tid
    Administration route: Oral
    Indication: Bipolar Disorder

Other drugs received by patient: Quetiapine; Hydroxychloroquine Sulfate; Aspirin; Simvastatin; Venlafaxine



Possible Lamotrigine side effects in 6 year old female

Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-08-21

Patient: 6 year old female

Reactions: Vomiting, Saccadic Eye Movement, Ataxia, Vertigo, Dizziness, Headache, Tremor

Drug(s) suspected as cause:
Lamotrigine
    Dosage: 200 mg, unk
    Indication: Epilepsy

Lamotrigine
    Dosage: 150 mg, unk

Valproate Sodium
    Dosage: 90 mg, unk
    Indication: Epilepsy

Other drugs received by patient: Nitrazepam



Possible Lamotrigine side effects in 59 year old female

Reported by a physician from United Kingdom on 2012-08-20

Patient: 59 year old female, weighing 83.5 kg (183.7 pounds)

Reactions: Drug Interaction, Muscular Weakness, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakote
    Administration route: Oral
    Indication: Bipolar Disorder

Lamotrigine
    Administration route: Oral
    Indication: Bipolar Disorder

Other drugs received by patient: Simvastatin; Venlafaxine; Quetiapine; Aspirin; Hydroxychloroquine Sulfate



Possible Lamotrigine side effects in 61 year old female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 61 year old female, weighing 54.4 kg (119.7 pounds)

Reactions: Incoherent, Pneumonia, Lymphadenopathy, Neoplasm Malignant, Nausea, Body Temperature Increased, Rash

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Lamotrigine



Possible Lamotrigine side effects in 22 year old female

Reported by a physician from Singapore on 2012-08-20

Patient: 22 year old female

Reactions: Oral Herpes, Erythema Multiforme, Stevens-Johnson Syndrome

Drug(s) suspected as cause:
Lamotrigine



Possible Lamotrigine side effects in 59 year old female

Reported by a physician from United Kingdom on 2012-08-20

Patient: 59 year old female, weighing 83.5 kg (183.7 pounds)

Reactions: Drug Interaction, Muscular Weakness, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lamotrigine
    Administration route: Oral
    Indication: Bipolar Disorder

Depakote
    Administration route: Oral
    Indication: Bipolar Disorder

Other drugs received by patient: Simvastatin; Quetiapine; Hydroxychloroquine Sulfate; Aspirin; Venlafaxine



Possible Lamotrigine side effects in 47 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 47 year old female, weighing 90.0 kg (198.0 pounds)

Reactions: Irritability, Weight Decreased, Panic Attack, Drug Ineffective, Depressed Mood, Haemorrhoidal Haemorrhage

Drug(s) suspected as cause:
Lamotrigine

Pristiq
    Dosage: formulation-prolonged release tab
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2012-04-13
    End date: 2012-06-13

Abilify
    Dosage: tab

Xanax
    Dosage: tab. 1df= half tab
    Administration route: Oral

Pristiq
    Dosage: formulation-prolonged release tab
    Administration route: Oral
    Indication: Depression
    Start date: 2012-04-13
    End date: 2012-06-13



Possible Lamotrigine side effects in 49 year old female

Reported by a pharmacist from United States on 2012-08-17

Patient: 49 year old female, weighing 68.0 kg (149.7 pounds)

Reactions: Meningitis Aseptic

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lamotrigine



Possible Lamotrigine side effects in

Reported by a physician from Jordan on 2012-08-17

Patient:

Reactions: Cellulitis, Lung Infection, Febrile Neutropenia, Convulsion, Death, Candida Test Positive, Agranulocytosis, Oral Candidiasis, Enterococcus Test Positive, Cardiac Arrest, Septic Shock, Aspergillus Test Positive, Pharyngitis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Venlafaxine Hydrocholride
    Dosage: 75 mg, qd
    Administration route: Oral
    Indication: Acute Psychosis

Quetiapine
    Dosage: 300 mg, qd
    Administration route: Oral
    Indication: Acute Psychosis

Lamotrigine
    Dosage: 100 mg, qd
    Administration route: Oral
    Indication: Acute Psychosis

Mirtazapine
    Dosage: 15 mg, qd
    Administration route: Oral
    Indication: Acute Psychosis

Other drugs received by patient: Ferrous Sulfate TAB



Possible Lamotrigine side effects in 24 year old male

Reported by a physician from Japan on 2012-08-16

Patient: 24 year old male

Reactions: Drug Ineffective, Atonic Seizures

Drug(s) suspected as cause:
Lamotrigine
    Indication: Infantile Spasms

Valproic Acid
    Indication: Infantile Spasms

Levetiracetam
    Indication: Infantile Spasms

Phenytoin
    Indication: Infantile Spasms

Carbamazepine
    Indication: Infantile Spasms

Other drugs received by patient: Nitrazepam; Corticotropin; Zonisamide; Ethosuximide; Vitamin B6



Possible Lamotrigine side effects in 6 year old female

Reported by a physician from Japan on 2012-08-16

Patient: 6 year old female

Reactions: Drug Ineffective, Atonic Seizures

Drug(s) suspected as cause:
Valproic Acid
    Indication: Infantile Spasms

Diazepam
    Indication: Infantile Spasms

Clonazepam
    Indication: Infantile Spasms

Topiramate
    Indication: Infantile Spasms

Clobazam
    Indication: Infantile Spasms

Phenytoin
    Indication: Infantile Spasms

Phenobarbital TAB
    Indication: Infantile Spasms

Lamotrigine
    Indication: Infantile Spasms

Other drugs received by patient: Corticotropin; Ethosuximide; Zonisamide



Possible Lamotrigine side effects in 7 year old male

Reported by a physician from Japan on 2012-08-16

Patient: 7 year old male

Reactions: Drug Ineffective, Atonic Seizures

Drug(s) suspected as cause:
Phenobarbital TAB
    Indication: Lennox-Gastaut Syndrome

Clobazam
    Indication: Lennox-Gastaut Syndrome

Phenytoin
    Indication: Lennox-Gastaut Syndrome

Topiramate
    Indication: Lennox-Gastaut Syndrome

Clonazepam
    Indication: Lennox-Gastaut Syndrome

Valproic Acid
    Indication: Lennox-Gastaut Syndrome

Lamotrigine
    Indication: Lennox-Gastaut Syndrome

Other drugs received by patient: Ethosuximide; Zonisamide



Possible Lamotrigine side effects in 8 year old female

Reported by a physician from Japan on 2012-08-16

Patient: 8 year old female

Reactions: Drug Ineffective, Atonic Seizures

Drug(s) suspected as cause:
Topiramate
    Indication: Infantile Spasms

Phenobarbital TAB
    Indication: Infantile Spasms

Carbamazepine
    Indication: Infantile Spasms

Lamotrigine
    Indication: Infantile Spasms

Valproic Acid
    Indication: Infantile Spasms

Clonazepam
    Indication: Infantile Spasms

Phenytoin
    Indication: Infantile Spasms

Diazepam
    Indication: Infantile Spasms

Other drugs received by patient: Benzodiazepine Derivatives; Corticotropin; Potassium Bromide



Possible Lamotrigine side effects in 3 year old female

Reported by a physician from Japan on 2012-08-16

Patient: 3 year old female

Reactions: Drug Ineffective, Atonic Seizures

Drug(s) suspected as cause:
Valproic Acid
    Dosage: daily
    Indication: Infantile Spasms

Lamotrigine
    Indication: Infantile Spasms

Clonazepam
    Dosage: daily
    Indication: Infantile Spasms

Topiramate
    Dosage: daily
    Indication: Infantile Spasms

Other drugs received by patient: Corticotropin; Vitamin B6; Zonisamide



Possible Lamotrigine side effects in 20 year old male

Reported by a physician from Japan on 2012-08-16

Patient: 20 year old male

Reactions: Drug Ineffective, Atonic Seizures

Drug(s) suspected as cause:
Phenobarbital TAB
    Indication: Infantile Spasms

Phenytoin
    Indication: Infantile Spasms

Clobazam
    Indication: Infantile Spasms

Gabapentin
    Indication: Infantile Spasms

Clonazepam
    Indication: Infantile Spasms

Valproic Acid
    Indication: Infantile Spasms

Lamotrigine
    Indication: Infantile Spasms

Carbamazepine
    Indication: Infantile Spasms

Other drugs received by patient: Sultiame; Corticotropin; Zonisamide

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