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 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 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 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 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 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 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 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 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 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 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 4 year old female
Reported by a physician from Japan on 2012-08-16
Patient: 4 year old female
Reactions: Drug Ineffective, Atonic Seizures
Drug(s) suspected as cause:
Clonazepam
Indication: Lennox-Gastaut Syndrome
Clobazam
Indication: Lennox-Gastaut Syndrome
Valproic Acid
Indication: Lennox-Gastaut Syndrome
Topiramate
Indication: Lennox-Gastaut Syndrome
Lamotrigine
Indication: Lennox-Gastaut Syndrome
Other drugs received by patient: Nitrazepam
Possible Lamotrigine side effects in 5 year old male
Reported by a physician from Japan on 2012-08-16
Patient: 5 year old male
Reactions: Drug Ineffective, Atonic Seizures
Drug(s) suspected as cause:
Clobazam
Indication: Infantile Spasms
Topiramate
Indication: Infantile Spasms
Phenytoin
Indication: Infantile Spasms
Lamotrigine
Indication: Infantile Spasms
Clonazepam
Indication: Infantile Spasms
Valproic Acid
Indication: Infantile Spasms
Gabapentin
Indication: Infantile Spasms
Other drugs received by patient: Acetazolamide; Nitrazepam; Corticotropin; Vitamin B6; Zonisamide
Possible Lamotrigine side effects in 37 year old male
Reported by a consumer/non-health professional from Canada on 2012-08-16
Patient: 37 year old male, weighing 64.0 kg (140.8 pounds)
Reactions: Akathisia, Stomatitis, Conjunctivitis, Parkinsonism, DRY Skin
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Lamotrigine
Dosage: 25 milligram daily;
Administration route: Oral
Petadolex
Dosage: 150 milligram daily;
Administration route: Oral
Other drugs received by patient: Vitamin B1 TAB; Magnesium Citrate; Vitamin B3; Coenzyme Q10; Folic Acid; Finasteride; Riboflavin CAP; Ascorbic Acid; Vitamin D; Lovaza; Vitamin B6; Pantothenic Acid
Possible Lamotrigine side effects in 59 year old female
Reported by a physician from United Kingdom on 2012-08-16
Patient: 59 year old female
Reactions: C-Reactive Protein Increased, Muscular Weakness, Drug Interaction, Rash Maculo-Papular, Stevens-Johnson Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lamotrigine
Indication: Bipolar Disorder
Depakote
Indication: Bipolar Disorder
Other drugs received by patient: Simvastatin; Hydroxychloroquine Sulfate; Quetiapine; Aspirin; Venlafaxine
Possible Lamotrigine side effects in 17 year old female
Reported by a physician from Japan on 2012-08-16
Patient: 17 year old female
Reactions: Drug Ineffective, Atonic Seizures
Drug(s) suspected as cause:
Clobazam
Indication: Infantile Spasms
Carbamazepine
Indication: Infantile Spasms
Valproic Acid
Indication: Infantile Spasms
Phenobarbital TAB
Indication: Infantile Spasms
Levetiracetam
Indication: Infantile Spasms
Gabapentin
Indication: Infantile Spasms
Clonazepam
Indication: Infantile Spasms
Lamotrigine
Indication: Infantile Spasms
Phenytoin
Indication: Infantile Spasms
Other drugs received by patient: Vitamin B6; Corticotropin; Zonisamide; Nitrazepam; Potassium Bromide; Benzodiazepine Derivatives
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
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