Lamotrigine Side Effects

Brand Names: Lamictal XR, Lamictal

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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

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.

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.

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.

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.

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.

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, suicidal thoughts or attempts); 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; 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.

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.

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, suicidal thoughts or attempts); 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; 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.

Lamotrigine Side Effects - for the Professional

Lamotrigine

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:

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.

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.

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%).

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%).

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.

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.

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.

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.

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.

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.

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.

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%).

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.

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.

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.

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: 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 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.

Side Effects by Body System

Hypersensitivity

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.

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.

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.

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%), and anorexia (2%) have been reported.

Respiratory

Respiratory side effects including rhinitis (14%), pharyngitis (10%), and increased cough (8%) 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.

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 include two cases of anemia. A case of agranulocytosis has also 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.

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