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Lamotrigine Side Effects

Brand Names: Lamictal, Lamictal ODT, Lamictal XR

Please note - some side effects for Lamotrigine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Lamotrigine - for the Consumer

Lamotrigine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lamotrigine:

Blurred or double vision; constipation; decreased coordination; diarrhea; dizziness; drowsiness; headache; nausea; painful menstrual periods; runny or stuffy nose; stomach upset or pain; tiredness; trouble sleeping; vomiting; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur when using Lamotrigine:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); absent menstrual period or other menstrual changes; calf pain or tenderness; chest pain; dark urine; difficult or painful urination; fast or irregular heartbeat; fever, chills, or persistent sore throat; new or worsening mental or mood changes (eg, anxiety, depression, restlessness, irritability, panic attacks, behavior changes); new or worsening seizures; pale stools; reddened, blistered, swollen, or peeling skin; severe muscle pain or tenderness; severe or persistent dizziness or stomach pain; shortness of breath; sores in the mouth or around the eyes; suicidal thoughts or attempts; swelling of the hands, ankles, or feet; swollen lymph glands; tremor; unusual bruising or bleeding; unusual weakness or tiredness; vaginal itching or discharge; vision changes; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Lamotrigine Chewable Dispersible Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lamotrigine Chewable Dispersible Tablets:

Blurred or double vision; constipation; decreased coordination; diarrhea; dizziness; drowsiness; headache; nausea; painful menstrual periods; runny or stuffy nose; stomach upset or pain; tiredness; trouble sleeping; vomiting; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur when using Lamotrigine Chewable Dispersible Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); absent menstrual period or other menstrual changes; calf pain or tenderness; chest pain; dark urine; difficult or painful urination; fast or irregular heartbeat; fever, chills, or persistent sore throat; new or worsening mental or mood changes (eg, anxiety, depression, restlessness, irritability, panic attacks, behavior changes); new or worsening seizures; pale stools; reddened, blistered, swollen, or peeling skin; severe muscle pain or tenderness; severe or persistent dizziness or stomach pain; shortness of breath; sores in the mouth or around the eyes; suicidal thoughts or attempts; swelling of the hands, ankles, or feet; swollen lymph glands; tremor; unusual bruising or bleeding; unusual weakness or tiredness; vaginal itching or discharge; vision changes; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Lamotrigine Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lamotrigine Extended-Release Tablets:

Blurred or double vision; constipation; decreased coordination; diarrhea; dizziness; drowsiness; headache; nausea; painful menstrual periods; runny or stuffy nose; stomach upset or pain; tiredness; trouble sleeping; vomiting; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur when using Lamotrigine Extended-Release Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unexplained hoarseness); absent menstrual period or other menstrual changes; calf pain or tenderness; chest pain; dark urine; difficult or painful urination; fast or irregular heartbeat; fever, chills, or persistent sore throat; new or worsening mental or mood changes (eg, anxiety, depression, restlessness, irritability, panic attacks, behavior changes); new or worsening seizures; pale stools; reddened, blistered, swollen, or peeling skin; severe muscle pain or tenderness; severe or persistent dizziness or stomach pain; shortness of breath; sores in the mouth or around the eyes; suicidal thoughts or attempts; swelling of the hands, ankles, or feet; swollen lymph glands; tremor; unusual bruising or bleeding; unusual weakness or tiredness; vaginal itching or discharge; vision changes; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Lamotrigine Orally Disintegrating Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lamotrigine Orally Disintegrating Tablets:

Blurred or double vision; constipation; decreased coordination; diarrhea; dizziness; drowsiness; headache; nausea; painful menstrual periods; runny or stuffy nose; stomach upset or pain; tiredness; trouble sleeping; vomiting; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur when using Lamotrigine Orally Disintegrating Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unexplained hoarseness); absent menstrual period or other menstrual changes; calf pain or tenderness; chest pain; dark urine; difficult or painful urination; fast or irregular heartbeat; fever, chills, or persistent sore throat; new or worsening mental or mood changes (eg, anxiety, depression, restlessness, irritability, panic attacks, behavior changes); new or worsening seizures; pale stools; reddened, blistered, swollen, or peeling skin; severe muscle pain or tenderness; severe or persistent dizziness or stomach pain; shortness of breath; sores in the mouth or around the eyes; suicidal thoughts or attempts; swelling of the hands, ankles, or feet; swollen lymph glands; tremor; unusual bruising or bleeding; unusual weakness or tiredness; vaginal itching or discharge; vision changes; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Lamotrigine Side Effects - for the Professional

Lamotrigine

The following adverse reactions are described in more detail in the Warnings and Precautions section of the label:

Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Lamotrigine has been evaluated for safety in patients with epilepsy and in patients with Bipolar I Disorder. Adverse reactions reported for each of these patient populations are provided below. Excluded are adverse reactions considered too general to be informative and those not reasonably attributable to the use of the drug.

Epilepsy: Most Common Adverse Reactions in All Clinical Studies: Adjunctive Therapy in Adults With Epilepsy: The most commonly observed (≥5% for Lamotrigine and more common on drug than placebo) adverse reactions 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 and Precautions (5.1)].

Approximately 11% of the 3,378 adult patients who received Lamotrigine as adjunctive therapy in premarketing clinical trials discontinued treatment because of an adverse reaction. The adverse reactions 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% for Lamotrigine and more common on drug than placebo) adverse reactions 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% for Lamotrigine and more common on drug than placebo) adverse reactions 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 reaction. The adverse reactions 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% for Lamotrigine and more common on drug than placebo) adverse reactions seen in association with the use of Lamotrigine as adjunctive treatment in pediatric patients 2 to16 years of age 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 2 to 16 years of age 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 reactions. The most commonly reported adverse reaction that led to discontinuation of Lamotrigine was rash.

Approximately 11.5% of the 1,081 pediatric patients 2 to 16 years of age who received Lamotrigine as adjunctive therapy in premarketing clinical trials discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with discontinuation were rash (4.4%), reaction aggravated (1.7%), and ataxia (0.6%).

Controlled Adjunctive Clinical Studies in Adults With Epilepsy: Table 8 lists treatment-emergent adverse reactions 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 reactions were usually mild to moderate in intensity.

Table 8. Treatment-Emergent Adverse Reaction Incidence in Placebo-Controlled Adjunctive Trials in Adult Patients With Epilepsy* (Adverse reactions in at least 2% of patients treated with Lamotrigine and numerically more frequent than in the placebo group.)
Body System/ Adverse Reaction Percent of Patients Receiving Adjunctive Lamotrigine (n = 711) Percent of Patients Receiving Adjunctive Placebo (n = 419)
*
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 reactions during the study or at discontinuation; thus, patients may be included in more than one category.
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
  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

In a randomized, parallel study comparing placebo and 300 and 500 mg/day of Lamotrigine, some of the more common drug-related adverse reactions were dose-related.

Table 9. Dose-Related Adverse Reactions From a Randomized, Placebo-Controlled Adjunctive Trial in Adults With Epilepsy
Percent of Patients Experiencing Adverse Reactions
Adverse Reaction Placebo (n = 73) Lamotrigine 300 mg (n = 71) Lamotrigine 500 mg (n = 72)
*
Significantly greater than placebo group (p<0.05).
†
Significantly greater than group receiving Lamotrigine 300 mg (p<0.05).
Ataxia 10 10 28*†
Blurred vision 10 11 25*†
Diplopia 8 24* 49*†
Dizziness 27 31 54*†
Nausea 11 18 25*
Vomiting 4 11 18*

The overall adverse reaction 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 reaction reports by race. Generally, females receiving either Lamotrigine as adjunctive therapy or placebo were more likely to report adverse reactions than males. The only adverse reaction 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 reactions.

Controlled Monotherapy Trial in Adults With Partial Seizures: Table 10 lists treatment-emergent adverse reactions 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 10. Treatment-Emergent Adverse Reaction Incidence in Adults With Partial Seizures in a Controlled Monotherapy Trial* (Adverse reactions in at least 5% of patients treated with Lamotrigine and numerically more frequent than in the valproate group.)
Body System/
Adverse Reaction		 Percent of Patients Receiving Lamotrigine as Monotherapy† (n = 43) Percent of Patients Receiving Low-Dose Valproate‡ Monotherapy (n = 44)
*
Patients in these studies were converted to Lamotrigine or valproate monotherapy from adjunctive therapy with carbamazepine or phenytoin. Patients may have reported multiple adverse reactions during the study; thus, patients may be included in more than one category.
†
Up to 500 mg/day.
‡
1,000 mg/day.
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

Adverse reactions 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, fever.

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 11 lists adverse reactions 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/day or a maximum of 750 mg/day. Reported adverse reactions were classified using COSTART terminology.

Table 11. Treatment-Emergent Adverse Reaction Incidence in Placebo-Controlled Adjunctive Trials in Pediatric Patients With Epilepsy (Adverse reactions in at least 2% of patients treated with Lamotrigine and numerically more frequent than in the placebo group.)
Body System/
Adverse Reaction		 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
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
  Visual abnormality 2 0
Urogenital
Male and female patients
  Urinary tract infection 3 0

Bipolar Disorder: The most commonly observed (≥5%) treatment-emergent adverse reactions seen in association with the use of Lamotrigine as monotherapy (100 to 400 mg/day) in adult patients (≥18 years of age) with 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 12. Adverse reactions 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 with 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 reaction. The adverse reactions which most commonly led to discontinuation of Lamotrigine were rash (3%) and mania/hypomania/mixed mood adverse reactions (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 reaction; most commonly due to rash (5%) and mania/hypomania/mixed mood adverse reactions (2%).

The overall adverse reaction profile for Lamotrigine was similar between females and males, between elderly and nonelderly patients, and among racial groups.

Table 12. Treatment-Emergent Adverse Reaction Incidence in 2 Placebo-Controlled Trials in Adults With Bipolar I Disorder* (Adverse reactions in at least 5% of patients treated with Lamotrigine as monotherapy and numerically more frequent than in the placebo group.)
Body System/
Adverse Reaction		 Percent of Patients Receiving Lamotrigine (n = 227) Percent of Patients Receiving Placebo (n = 190)
*
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 reactions during the study; thus, patients may be included in more than one category.
†
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 and Precautions (5.1)].
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)† 7 5

These adverse reactions were usually mild to moderate in intensity. Other reactions 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 reactions 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 Reactions Following Abrupt Discontinuation: In the 2 maintenance trials, there was no increase in the incidence, severity or type of adverse reactions in Bipolar Disorder patients after abruptly terminating therapy with Lamotrigine. 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 Warnings and Precautions (5.9)].

Mania/Hypomania/Mixed Episodes: During the double-blind, placebo-controlled clinical trials in Bipolar I Disorder in which patients were converted to monotherapy with Lamotrigine (100 to 400 mg/day) from other psychotropic medications and followed for up to 18 months, the rates of manic or hypomanic or mixed mood episodes reported as adverse reactions were 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 reactions 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).

Other Adverse Reactions Observed in All Clinical Trials

Lamotrigine has been administered to 6,694 individuals for whom complete adverse reaction data was captured during all clinical trials, only some of which were placebo controlled. During these trials, all adverse reactions were recorded by the clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals having adverse reactions, similar types of adverse reactions 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 adverse reactions 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.

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

Body as a Whole: Infrequent: Allergic reaction, chills, and malaise.

Cardiovascular System: Infrequent: Flushing, hot flashes, hypertension, palpitations, postural hypotension, syncope, tachycardia, and vasodilation.

Dermatological: Infrequent: 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, 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, 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, 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: Choreoathetosis, 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, hematuria, impotence, menorrhagia, polyuria, and urinary incontinence. Rare: Acute kidney failure, anorgasmia, breast abscess, breast neoplasm, creatinine increase, cystitis, dysuria, epididymitis, female lactation, kidney failure, kidney pain, nocturia, urinary retention, and urinary urgency.

Postmarketing Experience

The following adverse events (not listed above in clinical trials or other sections of the prescribing information) have been identified during postapproval use of Lamotrigine. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic: Agranulocytosis, hemolytic anemia

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: Progressive immunosuppression.

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Side Effects by Body System - for Healthcare Professionals

Hypersensitivity

Hypersensitivity reactions, some of which have been life-threatening or fatal, have been reported. Some of these reactions have included clinical features of multiorgan dysfunction such as hepatic abnormalities and evidence of disseminated intravascular coagulation. It is important to note that early manifestations of hypersensitivity (e.g., fever, lymphadenopathy) may be present even though a rash is not. If such signs or symptoms are present, the patient should be evaluated immediately. Lamotrigine should be discontinued if an alternative etiology for the signs or symptoms cannot be established.

When lamotrigine was added to concurrent antiepileptic drug therapy in controlled clinical studies, rash was reported in approximately 10% of patients. Severe, potentially life-threatening rashes have been reported in approximately 0.01% of patients. Rare deaths have also been reported. (The incidence of rash increases in multiple drug regimens.) Prior to initiation of treatment, patients should be instructed to report the occurrence of any new rashes to their physician.

Multiorgan failure, which in some cases has been fatal or irreversible, has been reported in patients receiving lamotrigine. Fatalities associated with multiorgan failure and various degrees of hepatic failure have been reported in 2 of 3,796 adult patients and 4 of 2,435 pediatric patients who received lamotrigine in clinical trials. No such fatalities have been reported in bipolar patients in clinical trials. Rare fatalities from multiorgan failure have also been reported in compassionate plea and postmarketing use. The majority of these deaths occurred in association with other serious medical events, including status epilepticus and overwhelming sepsis, and hantavirus making it difficult to identify the initial cause.

Three patients developed multiorgan dysfunction and disseminated intravascular coagulation nine to fourteen days after lamotrigine was added to their antiepileptic drug regimens. Rash and elevated transaminases were also present in all patients and rhabdomyolysis was noted in two patients. Two of the patients were receiving concomitant therapy with valproate, while the other patient was being treated with carbamazepine and clonazepam. All patients subsequently recovered with supportive care after treatment with lamotrigine was discontinued.

Rash resulting in hospitalization occurred in 0.3% of subjects who participated in clinical trials. These rashes included Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, and rash associated with a number of systemic manifestations.

Unless the potential benefits clearly outweigh the risks, lamotrigine should not be restarted in patients who discontinued treatment due to rash associated with prior treatment with lamotrigine.

Nervous system

Nervous system side effects including dizziness (38%), ataxia (22%), somnolence (14%), incoordination (6%), insomnia (6%), tremor (4%), depression (4%), anxiety (4%), convulsion (3%), irritability (3%), speech disorder (3%), and concentration disturbance (2%) have been reported. Two cases of aseptic meningitis have been reported. Exacerbation of Parkinsonian symptoms in patients with preexisting Parkinson's disease/tics has also been reported.

General

General side effects including headache (29%), flu syndrome (7%), fever (6%), abdominal pain (5%), neck pain (2%), and seizure exacerbation (2%) have been reported.

Ocular

Ocular side effects including diplopia (28%), blurred vision (16%), and vision abnormality (3%) have been reported. A case of blepharospasm has also been reported.

Gastrointestinal

Gastrointestinal side effects including nausea (19%), vomiting (9%), diarrhea (6%), dyspepsia (5%), constipation (4%), tooth disorder (3%), anorexia (2%), pancreatitis, and esophagitis have been reported.

Respiratory

Respiratory side effects including rhinitis (14%), pharyngitis (10%), increased cough (8%), and apnea have been reported. A case of interstitial pneumonitis has also been reported.

Dermatologic

Dermatologic side effects including rash (10%) and pruritus (3%) have been reported. Alopecia has been reported rarely. A case of toxic epidermal necrolysis has also been reported.

Genitourinary

Genitourinary side effects including dysmenorrhea (7%), vaginitis (4%), and amenorrhea (2%) have been reported.

Other

Other side effects including lymphadenopathy (2%) and three cases of dysgeusia have been reported. One study has reported that obese patients with bipolar I disorder lost weight while taking lamotrigine.

Metabolic

Metabolic side effects including edema (2%) have been reported.

Musculoskeletal

Musculoskeletal side effects including arthralgia (2%) have been reported.

Cardiovascular

Cardiovascular side effects including hemorrhage have been reported.

Hematologic

Hematologic side effects including hemolytic anemia and agranulocytosis have been reported.

Psychiatric

Psychiatric side effects including case reports of hypomania, delirium, and hallucinations have been reported. A case of lamotrigine-induced severe manic switch has also been reported.

Hepatic

Hepatic side effects have been reported including a case of acute hepatotoxicity (in the absence of other medications) and a case of fulminant hepatitis that occurred two weeks after introduction of lamotrigine.

Immunologic

Immunologic side effects including lupus-like reaction, vasculitis, and progressive immunosuppression have been reported.

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