Side Effects > Lamictal

Lamictal Side Effects

Generic Name: Lamotrigine

Please note - some side effects for Lamictal may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

For the consumer Lamictal Lamictal Chewable Dispersible Tablets For the professional Lamictal

Side Effects of Lamictal - for the consumer

Lamictal

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 Lamictal:

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 Lamictal:

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; 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 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.

Lamictal 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 Lamictal 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 Lamictal Chewable Dispersible 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; 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 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.

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For the professional

Lamictal

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

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 Lamictal 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 Lamictal than in patients receiving other AEDs with Lamictal. Clinical data suggest a higher incidence of rash, including serious rash, in patients receiving concomitant valproate than in patients not receiving valproate.

Approximately 11% of the 3,378 adult patients who received Lamictal 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 Lamictal 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 Lamictal 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 Lamictal 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 Lamictal 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 Lamictal 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 Lamictal 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 Lamictal and deterioration of seizure control for patients treated with placebo.

Approximately 11.5% of the 1,081 pediatric patients who received Lamictal 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 Lamictal in placebo-controlled trials and were numerically more common in the patients treated with Lamictal. In these studies, either Lamictal 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* (Events in at least 2% of patients treated with Lamictal and numerically more frequent than in the placebo group.)

Body System/ Adverse Experience†	Percent of Patients Receiving Adjunctive Lamictal (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

*Patients in these adjunctive studies were receiving 1 to 3 of the following concomitant AEDs (carbamazepine, phenytoin, phenobarbital, or primidone) in addition to Lamictal 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.

†Adverse experiences reported by at least 2% of patients treated with Lamictal are included.

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

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)	Lamictal 300 mg (n = 71)	Lamictal 500 mg (n = 72)
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*

*Significantly greater than placebo group (p<0.05).

†Significantly greater than group receiving Lamictal 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 Lamictal 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 Lamictal 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 Lamictal or placebo were more likely to report adverse experiences than males. The only adverse experience for which the reports on Lamictal 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 Lamictal 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 Lamictal 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* (Events in at least 5% of patients treated with Lamictal and numerically more frequent than in the valproate group.)

Body System/ Adverse Experience†	Percent of Patients Receiving Lamictal Monotherapy‡ (n = 43)	Percent of Patients Receiving Low-Dose Valproate§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

*Patients in these studies were converted to Lamictal 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.

†Adverse experiences reported by at least 5% of patients are included.

‡Up to 500 mg/day.

§1,000 mg/day.

Adverse events that occurred with a frequency of less than 5% and greater than 2% of patients receiving Lamictal 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 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 Lamictal 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 Lamictal and numerically more frequent than in the placebo group.)

Body System/ Adverse Experience	Percent of Patients Receiving Lamictal (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	n = 93	n = 92
Penis disorder	2	0

Bipolar Disorder: The most commonly observed (≥5%) adverse experiences seen in association with the use of Lamictal 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 Lamictal 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 Lamictal (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 Lamictal were rash (3%) and mania/hypomania/mixed mood adverse events (2%). Approximately 16% of 2,401 patients who received Lamictal (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 Lamictal for the Maintenance 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 Lamictal 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* (Events in at least 5% of patients treated with Lamictal monotherapy and numerically more frequent than in the placebo group.)

Body System/ Adverse Experience†	Percent of Patients Receiving Lamictal 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)‡	7	5

* Patients in these studies were converted to Lamictal (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.

† Adverse experiences reported by at least 5% of patients are included.

‡ 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 Lamictal as initial monotherapy and 0.13% (2 of 1,538) of adult patients who received Lamictal as adjunctive therapy.

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 Lamictal 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 Lamictal therapy. In clinical trials in patients with Bipolar Disorder, 2 patients experienced seizures shortly after abrupt withdrawal of Lamictal. However, there were confounding factors that may have contributed to the occurrence of seizures in these bipolar patients.

Mania/Hypomania/Mixed Episodes

During the double-blind, placebo-controlled clinical trials in Bipolar I Disorder in which patients were converted to Lamictal 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 Lamictal (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 Lamictal (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 Lamictal 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

Lamictal 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 presentedrepresent the proportion of the 6,694 individuals exposed to Lamictal who experienced an event of the type cited on at least one occasion while receiving Lamictal. 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

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, 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 Lamictal, the following adverse experiences have been reported in patients receiving marketed Lamictal 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.

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