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Lamotrigine (Lamotrigine) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

SERIOUS RASH REQUIRING HOSPITALIZATION AND DISCONTINUATION OF LAMOTRIGINE, INCLUDING STEVENS-JOHNSON SYNDROME AND TOXIC EPIDERMAL NECROLYSIS, HAVE OCCURRED IN ASSOCIATION WITH THERAPY WITH LAMOTRIGINE. RARE DEATHS HAVE BEEN REPORTED, BUT THEIR NUMBERS ARE TOO FEW TO PERMIT A PRECISE ESTIMATE OF THE RATE (BOXED WARNING).

Epilepsy:

Most Common Adverse Events in All Clinical Studies: Adjunctive Therapy in Adults With Epilepsy:

The most commonly observed (≥5%) adverse experiences seen in association with lamotrigine during adjunctive therapy in adults and not seen at an equivalent frequency among placebo-treated patients were: dizziness, ataxia, somnolence, headache, diplopia, blurred vision, nausea, vomiting, and rash. Dizziness, diplopia, ataxia, blurred vision, nausea, and vomiting were dose related. Dizziness, diplopia, ataxia, and blurred vision occurred more commonly in patients receiving carbamazepine with lamotrigine than in patients receiving other AEDs with lamotrigine. Clinical data suggest a higher incidence of rash, including serious rash, in patients receiving concomitant valproate than in patients not receiving valproate (see WARNINGS).

Approximately 11% of the 3,378 adult patients who received lamotrigine as adjunctive therapy in premarketing clinical trials discontinued treatment because of an adverse experience. The adverse events most commonly associated with discontinuation were rash (3.0%), dizziness (2.8%), and headache (2.5%).

In a dose response study in adults, the rate of discontinuation of lamotrigine for dizziness, ataxia, diplopia, blurred vision, nausea, and vomiting was dose related.

Monotherapy in Adults With Epilepsy:

The most commonly observed (≥5%) adverse experiences seen in association with the use of lamotrigine during the monotherapy phase of the controlled trial in adults not seen at an equivalent rate in the control group were vomiting, coordination abnormality, dyspepsia, nausea, dizziness, rhinitis, anxiety, insomnia, infection, pain, weight decrease, chest pain, and dysmenorrhea. The most commonly observed (≥5%) adverse experiences associated with the use of lamotrigine during the conversion to monotherapy (add-on) period, not seen at an equivalent frequency among low-dose valproate-treated patients, were dizziness, headache, nausea, asthenia, coordination abnormality, vomiting, rash, somnolence, diplopia, ataxia, accidental injury, tremor, blurred vision, insomnia, nystagmus, diarrhea, lymphadenopathy, pruritus, and sinusitis.

Approximately 10% of the 420 adult patients who received lamotrigine as monotherapy in premarketing clinical trials discontinued treatment because of an adverse experience. The adverse events most commonly associated with discontinuation were rash (4.5%), headache (3.1%), and asthenia (2.4%).

Adjunctive Therapy in Pediatric Patients With Epilepsy

The most commonly observed (≥5%) adverse experiences seen in association with the use of lamotrigine as adjunctive treatment in pediatric patients and not seen at an equivalent rate in the control group were infection, vomiting, rash, fever, somnolence, accidental injury, dizziness, diarrhea, abdominal pain, nausea, ataxia, tremor, asthenia, bronchitis, flu syndrome, and diplopia.

In 339 patients age 2 to 16 years with partial seizures or generalized seizures of Lennox­-Gastaut syndrome, 4.2% of patients on lamotrigine and 2.9% of patients on placebo discontinued due to adverse experiences. The most commonly reported adverse experiences that led to discontinuation were rash for patients treated with lamotrigine and deterioration of seizure control for patients treated with placebo.

Approximately 11.5% of the 1,081 pediatric patients who received lamotrigine as adjunctive therapy in premarketing clinical trials discontinued treatment because of an adverse experience. The adverse events most commonly associated with discontinuation were rash (4.4%), reaction aggravated (1.7%), and ataxia (0.6%).

Incidence in Controlled Clinical Studies of Epilepsy:

The prescriber should be aware that the figures in Tables 4, 5, 6, and 7 cannot be used to predict the frequency of adverse experiences in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescriber with one basis to estimate the relative contribution of drug and nondrug factors to the adverse event incidences in the population studied.

Incidence in Controlled Adjunctive Clinical Studies in Adults With Epilepsy:

Table 4 lists treatment-emergent signs and symptoms that occurred in at least 2% of adult patients with epilepsy treated with lamotrigine in placebo-controlled trials and were numerically more common in the patients treated with lamotrigine. In these studies, either lamotrigine or placebo was added to the patient's current AED therapy. Adverse events were usually mild to moderate in intensity.

Table 4. Treatment-Emergent Adverse Event Incidence in Placebo-Controlled Adjunctive Trials in Adult Patients With Epilepsy 1 (Events in at least 2% of patients treated with Lamotrigine and numerically more frequent than in the placebo group.)
Body System/Adverse Experience 2 Percent of Patients Receiving Adjunctive Lamotrigine (n=711) Percent of Patients Receiving Adjunctive Placebo (n=419)
Body as a whole    
Headache 29 19
Flu syndrome 7 6
Fever 6 4
Abdominal pain 5 4
Neck pain 2 1
Reaction aggravated (seizure exacerbation) 2 1
Digestive    
Nausea 19 10
Vomiting 9 4
Diarrhea 6 4
Dyspepsia 5 2
Constipation 4 3
Tooth disorder 3 2
Anorexia 2 1
Musculoskeletal    
Arthralgia 2 0
Nervous    
Dizziness 38 13
Ataxia 22 6
Somnolence 14 7
Incoordination 6 2
Insomnia 6 2
Tremor 4 1
Depression 4 3
Anxiety 4 3
Convulsion 3 1
Irritability 3 2
Speech disorder 3 0
Concentration disturbance 2 1
Respiratory    
Rhinitis 14 9
Pharyngitis 10 9
Cough increased 8 6
Skin and appendages    
Rash 10 5
Pruritus 3 2
Special senses    
Diplopia 28 7
Blurred vision 16 5
Vision abnormality 3 1
Urogenital    
Female patients only (n=365) (n=207)
Dysmenorrhea 7 6
Vaginitis 4 1
Amenorrhea 2 1

1 Patients in these adjunctive studies were receiving 1 to 3 of the following concomitant AEDs (carbamazepine, phenytoin, phenobarbital, or primidone) in addition to lamotrigine or placebo. Patients may have reported multiple adverse experiences during the study or at discontinuation; thus, patients may be included in more than one category
2 † Adverse experiences reported by at least 2% of patients treated with lamotrigine are included.

In a randomized, parallel study comparing placebo and 300 and 500 mg/day of lamotrigine, some of the more common drug-related adverse events were dose related (see Table 5).

Table 5. Dose-Related Adverse Events From a Randomized, Placebo-Controlled Trial in Adults With Epilepsy
  Percent of Patients Experiencing Adverse Experiences
Adverse Experience Placebo (n=73) Lamotrigine 300 mg (n=71) Lamotrigine 500 mg (n=72)
Ataxia 10 10 28 1 2
Blurred vision 10 11 25
Diplopia 8 24 49
Dizziness 27 31 54
Nausea 11 18 25
Vomiting 4 11 18

1  Significantly greater than placebo group (p<0.05)
2  Significantly greater than group receiving lamotrigine 300 mg (p<0.05).

Other events that occurred in more than 1% of patients but equally or more frequently in the placebo group included: asthenia, back pain, chest pain, flatulence, menstrual disorder, myalgia, paresthesia, respiratory disorder, and urinary tract infection.

The overall adverse experience profile for lamotrigine was similar between females and males, and was independent of age. Because the largest non-Caucasian racial subgroup was only 6% of patients exposed to lamotrigine in placebo-controlled trials, there are insufficient data to support a statement regarding the distribution of adverse experience reports by race. Generally, females receiving either adjunctive lamotrigine or placebo were more likely to report adverse experiences than males. The only adverse experience for which the reports on lamotrigine were greater than 10% more frequent in females than males (without a corresponding difference by gender on placebo) was dizziness (difference = 16.5%). There was little difference between females and males in the rates of discontinuation of lamotrigine for individual adverse experiences.

Incidence in a Controlled Monotherapy Trial in Adults With Partial Seizures:

Table 6 lists treatment-emergent signs and symptoms that occurred in at least 5% of patients with epilepsy treated with monotherapy with lamotrigine in a double-blind trial following discontinuation of either concomitant carbamazepine or phenytoin not seen at an equivalent frequency in the control group.

Table 6. Treatment-Emergent Adverse Event Incidence in Adults With Partial Seizures in a Controlled Monotherapy Trial 1 (Events in at atleast 5% of patients treated with Lamotrigine and numerically more frequent than in the valproate group.)
Body System/Adverse Experience 2 Percent of Patients Receiving Lamotrigine Monotherapy 3 (n=43) Percent of Patients Receiving Low-Dose Valproate 4 Monotherapy (n=44)
Body as a whole    
Pain 5 0
Infection 5 2
Chest pain 5 2
Digestive    
Vomiting 9 0
Dyspepsia 7 2
Nausea 7 2
Metabolic and nutritional    
Weight decrease 5 2
Nervous    
Coordination abnormality 7 0
Dizziness 7 0
Anxiety 5 0
Insomnia 5 2
Respiratory    
Rhinitis 7 2
Urogenital (female patients only) (n=21) (n=28)
Dysmenorrhea 5 0

1 Patients in these studies were converted to lamotrigine or valproate monotherapy from adjunctive therapy with carbamazepine or phenytoin. Patients may have reported multiple adverse experiences during the study; thus, patients may be included in more than one category
2 Adverse experiences reported by at least 5% of patients are included
3 Up to 500 mg/day
4 1,000 mg/day.

Adverse events that occurred with a frequency of less than 5% and greater than 2% of patients receiving lamotrigine and numerically more frequent than placebo were:

Body as a Whole: Asthenia, feve

Digestive: Anorexia, dry mouth, rectal hemorrhage, peptic ulcer.

Metabolic and Nutritional: Peripheral edema.

Nervous System : Amnesia, ataxia, depression, hypesthesia, libido increase, decreased reflexes, increased reflexes, nystagmus, irritability, suicidal ideation.

Respiratory: Epistaxis, bronchitis, dyspnea.

Skin and Appendages: Contact dermatitis, dry skin, sweating.

Special Senses : Vision abnormality.

Incidence in Controlled Adjunctive Trials in Pediatric Patients With Epilepsy:

Table 7 lists adverse events that occurred in at least 2% of 339 pediatric patients with partial seizures or generalized seizures of Lennox-Gastaut syndrome, who received lamotrigine up to 15 mg/kg per day or a maximum of 750 mg per day. Reported adverse events were classified using COSTART terminology.

Table 7. Treatment-Emergent Adverse Event Incidence in Placebo-Controlled Adjunctive Trials in Pediatric Patients With Epilepsy (Events in at least 2% of patients treated with Lamotrigine and numerically more frequent than in the placeo group.)
Body System/Adverse Experience Percent of Patients Receiving Lamotrigine (n=168) Percent of Patients Receiving Placebo (n=171)
Body as a whole    
Infection 20 17
Fever 15 14
Accidental injury 14 12
Abdominal pain 10 5
Asthenia 8 4
Flu syndrome 7 6
Pain 5 4
Facial edema 2 1
Photosensitivity 2 0
Cardiovascular    
Hemorrhage 2 1
Digestive    
Vomiting 20 16
Diarrhea 11 9
Nausea 10 2
Constipation 4 2
Dyspepsia 2 1
Tooth disorder 2 1
Hemic and lymphatic    
Lymphadenopathy 2 1
Metabolic and nutritional    
Edema 2 0
Nervous system    
Somnolence 17 15
Dizziness 14 4
Ataxia 11 3
Tremor 10 1
Emotional lability 4 2
Gait abnormality 4 2
Thinking abnormality 3 2
Convulsions 2 1
Nervousness 2 1
Vertigo 2 1
Respiratory    
Pharyngitis 14 11
Bronchitis 7 5
Increased cough 7 6
Sinusitis 2 1
Bronchospasm 2 1
Skin    
Rash 14 12
Eczema 2 1
Pruritus 2 1
Special senses    
Diplopia 5 1
Blurred vision 4 1
Ear disorder 2 1
Visual abnormality 2 0
Urogenital    
Male and female patients Urinary tract infection 3 0
Male patients only Penis disorder n=93
2
n=92
0

Bipolar Disorder:

The most commonly observed (≥5%) adverse experiences seen in association with the use of lamotrigine as monotherapy (100 to 400 mg/day) in Bipolar Disorder in the 2 double-blind, placebo-controlled trials of 18 months' duration, and numerically more frequent than in placebo-treated patients are included in Table 8.

Adverse events that occurred in at least 5% of patients and were numerically more common during the dose escalation phase of lamotrigine in these trials (when patients may have been receiving concomitant medications) compared to the monotherapy phase were: headache (25%), rash (11%), dizziness (10%), diarrhea (8%), dream abnormality (6%), and pruritus (6%).

During the monotherapy phase of the double-blind, placebo-controlled trials of 18 months’duration, 13% of 227 patients who received lamotrigine (100 to 400 mg/day), 16% of 190 patients who received placebo, and 23% of 166 patients who received lithium discontinued therapy because of an adverse experience. The adverse events which most commonly led to discontinuation of lamotrigine were rash (3%) and mania/hypomania/mixed mood adverse events (2%). Approximately 16% of 2,401 patients who received lamotrigine (50 to 500 mg/day) for Bipolar Disorder in premarketing trials discontinued therapy because of an adverse experience; most commonly due to rash (5%) and mania/hypomania/mixed mood adverse events (2%).

Incidence in Controlled Clinical Studies of Lamotrigine for the Maintenance and Treatment of Bipolar I Disorder:

Table 8 lists treatment-emergent signs and symptoms that occurred in at least 5% of patients with Bipolar Disorder treated with lamotrigine monotherapy (100 to 400 mg/day), following the discontinuation of other psychotropic drugs, in 2 double-blind, placebo-controlled trials of 18 months' duration and were numerically more frequent than in the placebo group.

Table 8. Treatment-Emergent Adverse Event Incidence in 2 Placebo-Controlled Trials in Adults With Bipolar I Disorder 1 (Events in at least 5% of patients treated with Lamotrigine monotherapy and numerically more frequent than in the placebo group.)
Body System/Adverse Experience 2 Percent of Patients Receiving Lamotrigine n=227 Percent of Patients Receiving Placebo n=190
General    
Back pain 8 6
Fatigue 8 5
Abdominal pain 6 3
Digestive    
Nausea 14 11
Constipation 5 2
Vomiting 5 2
Nervous System    
Insomnia 10 6
Somnolence 9 7
Xerostomia (dry mouth) 6 4
Respiratory    
Rhinitis 7 4
Exacerbation of cough 5 3
Pharyngitis 5 4
Skin    
Rash (nonserious) 3 7 5

1 Patients in these studies were converted to lamotrigine (100 to 400 mg/day) or placebo monotherapy from add-on therapy with other psychotropic medications. Patients may have reported multiple adverse experiences during the study; thus, patients may be included in more than one category
2 Adverse experiences reported by at least 5% of patients are included
3 In the overall bipolar and other mood disorders clinical trials, the rate of serious rash was 0.08% (1 of 1,233) of adult patients who received lamotrigine as initial monotherapy and 0.13% (2 of 1,538) of adult patients who received lamotrigine as adjunctive therapy (see WARNINGS).

These adverse events were usually mild to moderate in intensity.

Other events that occurred in 5% or more patients but equally or more frequently in the placebo group included: dizziness, mania, headache, infection, influenza, pain, accidental injury, diarrhea, and dyspepsia.

Adverse events that occurred with a frequency of less than 5% and greater than 1% of patients receiving lamotrigine and numerically more frequent than placebo were:

General: Fever, neck pain

Cardiovascular: Migraine

Digestive: Flatulence

Metabolic and Nutritional: Weight gain, edema

Musculoskeletal: Arthralgia, myalgia

Nervous System:: Amnesia, depression, agitation, emotional lability, dyspraxia, abnormal thoughts, dream abnormality, hypoesthesia

Respiratory: Sinusitis

Urogenital: Urinary frequency.

Adverse Events Following Abrupt Discontinuation:

In the 2 maintenance trials, there was no increase in the incidence, severity or type of adverse events in Bipolar Disorder patients after abruptly terminating lamotrigine therapy. In clinical trials in patients with Bipolar Disorder, 2 patients experienced seizures shortly after abrupt withdrawal of lamotrigine. However, there were confounding factors that may have contributed to the occurrence of seizures in these bipolar patients (see DOSAGE AND ADMINISTRATION).

Mania/Hypomania/Mixed Episodes:

During the double-blind, placebo-controlled clinical trials in Bipolar I Disorder in which patients were converted to lamotrigine monotherapy (100 to 400 mg/day) from other psychotropic medications and followed for durations up to 18 months, the rate of manic or hypomanic or mixed mood episodes reported as adverse experiences was 5% for patients treated with lamotrigine (n = 227), 4% for patients treated with lithium (n = 166), and 7% for patients treated with placebo (n = 190). In all bipolar controlled trials combined, adverse events of mania (including hypomania and mixed mood episodes) were reported in 5% of patients treated with lamotrigine (n = 956), 3% of patients treated with lithium (n = 280), and 4% of patients treated with placebo (n = 803).

The overall adverse event profile for lamotrigine was similar between females and males, between elderly and nonelderly patients, and among racial groups

Other Adverse Events Observed During All Clinical Trials For Pediatric and Adult Patients With Epilepsy or Bipolar Disorder and Other Mood Disorders:

 Lamotrigine has been administered to 6,694 individuals for whom complete adverse event data was captured during all clinical trials, only some of which were placebo controlled. During these trials, all adverse events were recorded by the clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals having adverse events, similar types of events were grouped into a smaller number of standardized categories using modified COSTART dictionary terminology. The frequencies presented represent the proportion of the 6,694 individuals exposed to lamotrigine who experienced an event of the type cited on at least one occasion while receiving lamotrigine. All reported events are included except those already listed in the previous tables or elsewhere in the labeling, those too general to be informative, and those not reasonably associated with the use of the drug.

Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1,000 patients; rare adverse events are those occurring in fewer than 1/1,000 patients.

Body as a Whole: Infrequent: Allergic reaction, chills, halitosis, and malaise. Rare: Abdomen enlarged, abscess, and suicide/suicide attempt.

Cardiovascular System: Infrequent: Flushing, hot flashes, hypertension, palpitations, postural hypotension, syncope, tachycardia, and vasodilation. Rare: Angina pectoris, atrial fibrillation, deep thrombophlebitis, ECG abnormality, and myocardial infarction.

Dermatological: Infrequen t: Acne, alopecia, hirsutism, maculopapular rash, skin discoloration, and urticaria. Rare : Angioedema, erythema, exfoliative dermatitis, fungal dermatitis, herpes zoster, leukoderma, multiforme erythema, petechial rash, pustular rash, seborrhea, Stevens-Johnson syndrome, and vesiculobullous rash.

Digestive System: Infrequent: Dysphagia, eructation, gastritis, gingivitis, increased appetite, increased salivation, liver function tests abnormal, and mouth ulceration. Rare : Gastrointestinal hemorrhage, glossitis, gum hemorrhage, gum hyperplasia, hematemesis, hemorrhagic colitis, hepatitis, melena, stomach ulcer, stomatitis, thirst, and tongue edema.

Endocrine System: Rare: Goiter and hypothyroidism.

Hematologic and Lymphatic System: Infrequent: Ecchymosis and leukopenia. Rare: Anemia, eosinophilia, fibrin decrease, fibrinogen decrease, iron deficiency anemia, leukocytosis, lymphocytosis, macrocytic anemia, petechia, and thrombocytopenia.

Metabolic and Nutritional Disorders: Infrequent : Aspartate transaminase increased. Rare: Alcohol intolerance, alkaline phosphatase increase, alanine transaminase increase, bilirubinemia, general edema, gamma glutamyl transpeptidase increase, and hyperglycemia.

Musculoskeletal System: Infrequent: Arthritis, leg cramps, myasthenia, and twitching. Rare: Bursitis, joint disorder, muscle atrophy, pathological fracture, and tendinous contracture.

Nervous System: Frequent : Confusion and paresthesia. Infrequent: Akathisia, apathy, aphasia, CNS depression, depersonalization, dysarthria, dyskinesia, euphoria, hallucinations, hostility, hyperkinesia, hypertonia, libido decreased, memory decrease, mind racing, movement disorder, myoclonus, panic attack, paranoid reaction, personality disorder, psychosis, sleep disorder, stupor, and suicidal ideation. Rare : Cerebellar syndrome, cerebrovascular accident, cerebral sinus thrombosis, choreoathetosis, CNS stimulation, delirium, delusions, dysphoria, dystonia, extrapyramidal syndrome, faintness, grand mal convulsions, hemiplegia, hyperalgesia, hyperesthesia, hypokinesia, hypotonia, manic depression reaction, muscle spasm, neuralgia, neurosis, paralysis, and peripheral neuritis.

Respiratory System: Infrequent: Yawn. Rare: Hiccup and hyperventilation.

Special Senses: Frequent: Amblyopia. Infrequent : Abnormality of accommodation, conjunctivitis, dry eyes, ear pain, photophobia, taste perversion, and tinnitus. Rare: Deafness, lacrimation disorder, oscillopsia, parosmia, ptosis, strabismus, taste loss, uveitis, and visual field defect.

Urogenital System: Infrequent : Abnormal ejaculation, breast pain, hematuria, impotence, menorrhagia, polyuria, urinary incontinence, and urine abnormality. Rare : Acute kidney failure, anorgasmia, breast abscess, breast neoplasm, creatinine increase, cystitis, dysuria, epididymitis, female lactation, kidney failure, kidney pain, nocturia, urinary retention, urinary urgency, and vaginal moniliasis.

Postmarketing and Other Experience: In addition to the adverse experiences reported during clinical testing of lamotrigine, the following adverse experiences have been reported in patients receiving marketed lamotrigine and from worldwide noncontrolled investigational use. These adverse experiences have not been listed above, and data are insufficient to support an estimate of their incidence or to establish causation.

Blood and Lymphatic : Agranulocytosis, aplastic anemia, disseminated intravascular coagulation, hemolytic anemia, neutropenia, pancytopenia, red cell aplasia.

Gastrointestinal: Esophagitis.

Hepatobiliary Tract and Pancreas: Pancreatitis.

Immunologic: Lupus-like reaction, vasculitis.

Lower Respiratory: Apnea.

Musculoskeletal: Rhabdomyolysis has been observed in patients experiencing hypersensitivity reactions.

Neurology: Exacerbation of parkinsonian symptoms in patients with pre-existing Parkinson's disease, tics.

Non-site Specific: Hypersensitivity reaction, multiorgan failure, progressive immunosuppression.



REPORTS OF SUSPECTED LAMOTRIGINE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Lamotrigine. The information is not vetted and should not be considered as verified clinical evidence.

Possible Lamotrigine side effects / adverse reactions in 51 year old female

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 51 year old female weighing 88.0 kg (193.6 pounds)

Reactions: Blood Pressure Increased

Suspect drug(s):
Lamotrigine

Other drugs received by patient: Lamotrigine; Effexor XR; Nexium; Adderall -Generic



Possible Lamotrigine side effects / adverse reactions in 10 year old female

Reported by a individual with unspecified qualification from United States on 2011-10-03

Patient: 10 year old female

Reactions: Dysarthria, Drooling, Fatigue, Medication Error, Hypophagia, Gait Disturbance, Posture Abnormal, Convulsion

Suspect drug(s):
Topiramate
    Dosage: (25 mg),oral
    Administration route: Oral

Lamotrigine
    Dosage: (25 mg),oral
    Administration route: Oral



Possible Lamotrigine side effects / adverse reactions in 48 year old female

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 48 year old female

Reactions: Skin Exfoliation, Drug Rash With Eosinophilia and Systemic Symptoms

Adverse event resulted in: hospitalization

Suspect drug(s):
Lamotrigine
    Dosage: 50 mg; 100 mg; qd
    Indication: Depression
    End date: 2011-08-22

Lamotrigine
    Dosage: 50 mg; 100 mg; qd
    Indication: Affective Disorder
    End date: 2011-08-22

Lamotrigine
    Dosage: 50 mg; 100 mg; qd
    Indication: Depression
    Start date: 2011-08-23
    End date: 2011-08-25

Lamotrigine
    Dosage: 50 mg; 100 mg; qd
    Indication: Affective Disorder
    Start date: 2011-08-23
    End date: 2011-08-25

Lamotrigine
    Dosage: 100 mg; qd; po
    Administration route: Oral
    Indication: Affective Disorder
    Start date: 2011-08-26
    End date: 2011-08-30

Lamotrigine
    Dosage: 100 mg; qd; po
    Administration route: Oral
    Indication: Depression
    Start date: 2011-08-26
    End date: 2011-08-30

Other drugs received by patient: Senna; Ramipril; Synthroid; Coumadin; Colace; Coreg; Celexa



See index of all Lamotrigine side effect reports >>

Drug label data at the top of this Page last updated: 2009-06-08

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