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Lamictal XR Side Effects

Generic Name: lamotrigine

Note: This document contains side effect information about lamotrigine. Some of the dosage forms listed on this page may not apply to the brand name Lamictal XR.

In Summary

Common side effects of Lamictal XR include: ataxia, skin rash, headache, insomnia, and nausea. Other side effects include: infection, dyspepsia, abnormal gait, constipation, and drowsiness. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to lamotrigine: oral tablet, oral tablet chewable, oral tablet disintegrating, oral tablet extended release

Warning

Oral route (Tablet; Tablet, Chewable; Tablet, Disintegrating; Tablet, Extended Release)

Cases of life-threatening serious rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, or rash-related death have been caused by lamotrigine. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include: (1) coadministration with valproate; (2) exceeding recommended initial dose of lamotrigine; or (3) exceeding recommended dose escalation for lamotrigine. Benign rashes are also caused by lamotrigine; however, it is not possible to predict which rashes will prove to be serious or life threatening. Lamotrigine should be discontinued at the first sign of rash, unless the rash is clearly not drug related.

Along with its needed effects, lamotrigine (the active ingredient contained in Lamictal XR) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lamotrigine:

More Common

  • Blurred vision
  • changes in vision
  • clumsiness or unsteadiness
  • double vision
  • poor coordination
  • skin rash

Less Common

  • Anxiety
  • chest pain
  • confusion
  • continuous, uncontrolled back and forth or rolling eye movements
  • depression
  • increase in seizures
  • infection
  • irritability

Rare

  • Blistering, peeling, or loosening of the skin
  • chills
  • cough
  • dark urine
  • diarrhea
  • fever
  • general feeling of discomfort or illness
  • headache
  • itching
  • joint pain
  • loss of appetite
  • memory loss
  • muscle cramps, pain, or weakness
  • nausea
  • red or irritated eyes
  • runny nose
  • shivering
  • small red or purple spots on the skin
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swelling of the face, mouth, hands, or feet
  • swollen lymph nodes
  • trouble sleeping
  • trouble with breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • yellow eyes or skin

Incidence Not Known

  • Back, leg, or stomach pains
  • bleeding gums
  • bloating
  • blood in the urine
  • bloody, black or tarry stools
  • bluish lips or skin
  • bruising
  • constipation
  • cough
  • coughing or vomiting blood
  • difficulty with breathing
  • difficulty with swallowing
  • fainting
  • fast heartbeat
  • general body swelling
  • general feeling of tiredness or weakness
  • heartburn
  • high fever
  • hoarseness
  • lightheadedness
  • loss of balance control
  • lower back or side pain
  • mask-like face
  • muscle spasms
  • nosebleeds
  • not breathing
  • pain or burning in the throat
  • painful or difficult urination
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • persistent bleeding or oozing from puncture sites, mouth, or nose
  • rapid, shallow breathing
  • redness, soreness, or itching skin
  • shuffling walk
  • slowed movement
  • slurred speech
  • sores, welting, or blisters
  • stiffness of the arms and legs
  • swollen or painful glands
  • tic-like (jerky) movements
  • tightness in the chest
  • unexplained bleeding or bruising

Get emergency help immediately if any of the following symptoms of overdose occur while taking lamotrigine:

Symptoms of Overdose

  • Clumsiness or unsteadiness (severe)
  • continuous, uncontrolled back and forth or rolling eye movements (severe)
  • dizziness (severe)
  • drowsiness (severe)
  • dryness of the mouth (severe)
  • headache (severe)
  • increased heart rate
  • loss of consciousness
  • slurred speech (severe)

Some side effects of lamotrigine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Dizziness
  • drowsiness

Less Common

  • Indigestion
  • loss of strength
  • menstrual pain
  • pain
  • trembling or shaking
  • trouble with sleeping
  • unusual weight loss

For Healthcare Professionals

Applies to lamotrigine: oral tablet, oral tablet disintegrating, oral tablet dispersible, oral tablet extended release

General

The more commonly reported adverse reactions have included dizziness, headache, diplopia, ataxia, nausea, blurred vision, somnolence, and rash.[Ref]

Immunologic

Postmarketing reports: Progressive immunosuppression, Lupus-like reaction, vasculitis, drug reaction with eosinophilia and systemic symptoms (DRESS), hemophagocytic lymphohistiocytosis (HLH)[Ref]

In cases of hemophagocytic lymphohistiocytosis (HLH), patients have presented with signs of systemic inflammation (fever, rash, hepatosplenomegaly, and organ system dysfunction) and blood dyscrasias. Symptoms have been reported within 8 to 24 days.[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reaction, chills, malaise[Ref]

Nervous system

Very common (10% or more): Dizziness (38%), headache (29%), ataxia (22%), somnolence (14%)

Common (1% to 10%): Seizure exacerbation, incoordination, insomnia, tremor, speech disorder, amnesia, hypoesthesia, pain, gait abnormality, vertigo, dyspraxia, confusion, paresthesia

Uncommon (0.1% to 1%): Akathisia, aphasia, central nervous system depression, dysarthria, dyskinesia, hyperkinesia, hypertonia, movement disorder, myoclonus, sudden unexplained death in Epilepsy (SUDEP)

Rare (less than 0.1%): Choreoathetosis, dystonia, extrapyramidal syndrome, faintness, grand mal seizures, hemiplegia, hyperalgesia, hyperesthesia, hypokinesia, hypotonia, neuralgia, muscle spasm, neuralgia, paralysis, peripheral neuritis

Very rare (less than 0.01%): Muscle spasm, paralysis, peripheral neuritis

Postmarketing reports: Exacerbation of Parkinsonian symptoms in patients with pre-existing Parkinson's disease, tics[Ref]

Sudden unexplained death in epilepsy (SUDEP) was reported in 20 of 4700 patients with epilepsy during premarketing development. While this exceeds the expected rate in healthy populations, it is within the range for patients with epilepsy.[Ref]

Psychiatric

Common (1% to 10%): Depression, anxiety, irritability, disturbance of concentration, emotional lability, abnormal thinking, nervousness

Uncommon (0.1% to 1%): Apathy, euphoria, hallucinations, hostility, depersonalization, memory decrease, mind racing, panic attack, paranoid reaction, personality disorder, psychosis, sleep disorder, stupor, suicidal ideation

Rare (less than 0.1%): Delirium, delusions, dysphoria, manic depression reaction, neurosis

Postmarketing reports: Aggression, nightmares[Ref]

Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior. Pooled analyses of 199 placebo-controlled clinical trials of 11 different AEDs (monotherapy or adjunctive therapy) showed twice the risk compared with placebo patients; an estimated incidence of 0.43% (n=27,863) in AED-treated patients compared to 0.24% (n=16,029) in placebo. The median treatment duration was 12 weeks. There were 4 suicides in AED-treated patients (placebo=0). The risk of suicidal thoughts or behavior was considered similar among the drugs studied despite their varying mechanisms of action suggesting the risk applies to all AEDs used for any indication. Additionally, the risk did not vary substantially by age.[Ref]

Ocular

Very common (10% or more): Diplopia (28%), blurred vision (16%)

Common (1% to 10%): Vision abnormality, nystagmus, photosensitivity, amblyopia

Uncommon (0.1% to 1%): Abnormality of accommodation, conjunctivitis, dry eyes, photophobia

Rare (less than 0.1%): Lacrimation disorder, oscillopsia, ptosis, strabismus, uveitis, visual field defect[Ref]

Gastrointestinal

Very common (10% or more): Vomiting (20%), nausea (19%), diarrhea (10%)

Common (1% to 10%): Abdominal pain, vomiting, dyspepsia, constipation, anorexia, dry mouth, rectal hemorrhage, peptic ulcer, flatulence

Uncommon (0.1% to 1%): Dysphagia, eructation, gastritis, gingivitis, increased appetite, increased salivation, mouth ulceration

Rare (less than 0.1%): Gastrointestinal hemorrhage, glossitis, gum hemorrhage, gum hyperplasia, hematemesis, hemorrhagic colitis, melena, stomach ulcer, stomatitis, tongue edema

Very rare (less than 0.01%): Pancreatitis, esophagitis[Ref]

Respiratory

Very common (10% or more): Rhinitis (14%)

Common (1% to 10%): Pharyngitis, increased cough, epistaxis, dyspnea, bronchitis, sinusitis, bronchospasm

Uncommon (0.1% to 1%): Yawn

Rare (less than 0.1%): Hiccup, hyperventilation

Postmarketing reports: Apnea[Ref]

Dermatologic

In adult patients (n=3348), serious rash associated with hospitalization and discontinuation was reported in 0.3% of patients in premarketing epilepsy trials. In bipolar trials, serious rash occurred in 0.08% of patients receiving this drug as initial monotherapy and 0.13% of patients receiving this drug as adjunctive therapy. In worldwide postmarketing experience, rash-related death has been reported, but the numbers are too few to permit a precise estimate of rate.

In a prospectively followed cohort of pediatric patients 2 to 17 years old, the incidence of serious rash was approximately 0.3% to 0.8%. In a prospectively followed cohort of patients 2 to 16 years old (n=1983), 1 rash-related death occurred in a patient with epilepsy taking this drug as adjunctive therapy.

Evidence has show the inclusion of valproate in a multidrug regimen increases the risk of serious, potentially life-threatening rash in both adult and pediatric patients. In pediatric patients who used valproate concomitantly for epilepsy, 1.2% (6 of 482) experienced a serious rash (placebo=0.6%). In adults, 1% of patients of patients receiving this drug in combination with valproate (n=584) experienced a rash (placebo=0.16%).[Ref]

Very common (10% or more): Rash (14%)

Common (1% to 10%): Contact dermatitis, dry skin, sweating, eczema, pruritus

Uncommon (0.1% to 1%): Acne, alopecia, hirsutism, maculopapular rash, skin discoloration, urticaria, ecchymosis, leukopenia

Rare (less than 0.1%): Angioedema, erythema, exfoliative dermatitis, fungal dermatitis, herpes zoster, leukoderma, multiforme erythema, petechial rash, pustular rash, Stevens-Johnson syndrome, vesiculobullous rash, anemia, eosinophilia, fibrin decrease, fibrinogen decrease, iron deficiency anemia, leukocytosis, lymphocytosis, macrocytic anemia, thrombocytopenia[Ref]

Genitourinary

Common (1% to 10%): Dysmenorrhea, vaginitis, amenorrhea, libido increase, urinary tract infection (both male and female), urinary frequency

Uncommon (0.1% to 1%): Libido decreased, abnormal ejaculation, hematuria, impotence, menorrhagia, polyuria, urinary incontinence

Rare (less than 0.1%): Anorgasmia, breast abscess, breast neoplasm, creatinine increase, cystitis, dysuria, epididymitis, female lactation, nocturia, urinary retention, urinary urgency[Ref]

Other

Very common (10% or more): Fever (15%), accidental injury (14%)

Common (1% to 10%): Fatigue

Uncommon (0.1% to 1%): Ear pain, taste perversion, tinnitus

Rare (less than 0.1%): Alcohol intolerance, deafness, taste loss, parosmia, taste loss[Ref]

Metabolic

Common (1% to 10%): Weight decrease, weight gain, peripheral edema, facial edema

Rare (less than 0.1%): Bilirubinemia, general edema, gamma glutamyl transpeptidase increase, hyperglycemia[Ref]

Musculoskeletal

Common (1% to 10%): Neck pain, arthralgia, myalgia, decreased reflexes, back pain, increased reflexes, asthenia

Uncommon (0.1% to 1%): Arthritis, leg cramps, myasthenia, twitching

Rare (less than 0.1%): Bursitis, muscle atrophy, pathological fracture, tendinous contracture

Postmarketing reports: Rhabdomyolysis (among patients experiencing hypersensitivity reactions)[Ref]

Cardiovascular

Common (1% to 10%): Chest pain, migraine

Uncommon (0.1% to 1%): Flushing, hot flashes, hypertension, palpitations, postural hypotension, syncope, tachycardia, vasodilation[Ref]

Hematologic

Postmarketing reports: Agranulocytosis, hemolytic anemia, lymphadenopathy not associated with hypersensitivity disorder[Ref]

Hepatic

Common (1% to 10%): Lymphadenopathy

Uncommon (0.1% to 1%): Liver function tests abnormal, aspartate transaminase (AST) increased

Rare (less than 0.1%): Hepatitis, alanine transaminase ALT) increased, acute kidney failure, kidney failure, kidney pain[Ref]

References

1. "Product Information. LaMICtal XR (lamoTRIgine)." GlaxoSmithKline, Research Triangle Park, NC.

2. "Product Information. Lamictal (lamotrigine)." Glaxo Wellcome, Research Triangle Park, NC.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

5. Chaffin JJ, Davis SM "Suspected lamotrigine-induced toxic epidermal necrolysis." Ann Pharmacother 31 (1997): 720-3

6. Wadelius M, Karlsson T, Wadelius C "Lamotrigine and toxic epidermal necrolysis." Lancet 348 (1996): 1041

7. Page RL, ONeil MG, Yarbrough DR, Conradi S "Fatal toxic epidermal necrolysis related to lamotrigine administration." Pharmacotherapy 18 (1998): 392-8

8. Sachs B, Ronnau AC, Ruzicka T, Gleichmann E, Schuppe HC "Lamotrigine and toxic epidermal necrolysis." Lancet 348 (1996): 1597

9. Hilas O, Charneski L "Lamotrigine-induced Stevens-Johnson syndrome." Am J Health Syst Pharm 64 (2007): 273-275

10. Boot B "Recurrent lamotrigine-induced aseptic meningitis." Epilepsia 50 (2009): 968-9

11. Mikati MA, Schachter SC, Schomer DL, Keally M, Osborne-Shafer P, Seaman CA, Sheridan PH, Ashworth M, Kupferberg H, Valakas A, et al "Long-term tolerability, pharmacokinetic and preliminary efficacy study of lamotrigine in patients with resistant partial seizures." Clin Neuropharmacol 12 (1989): 312-21

12. Desarkar P, Sinha VK "Lamotrigine-induced severe manic switch." Aust N Z J Psychiatry 40 (2006): 718

13. Margolese HC, Beauclair L, Szkrumelak N, Chouinard G "Hypomania Induced by Adjunctive Lamotrigine." Am J Psychiatry 160 (2003): 183-184

14. Uher R, Jones HM "Hallucinations during lamotrigine treatment of bipolar disorder." Am J Psychiatry 163 (2006): 749-50

15. Mueller TH, Beeber AR "Delirium From Valproic Acid With Lamotrigine." Am J Psychiatry 161 (2004): 1128-1129

16. Verma A, Miller P, Carwile ST, Husain AM, Radtke "Lamotrigine-induced blepharospam." Pharmacotherapy 19 (1999): 877-80

17. Saravanan N, Musibay Otaiku O, Namushi Namushi R "Interstitial pneumonitis during lamotrigine therapy." Br J Clin Pharmacol 60 (2005): 666-7

18. Hillemacher T, Bleich S, Kornhuber J, Frieling H "Hair loss as a side effect of lamotrigine treatment." Am J Psychiatry 163 (2006): 1451

19. Schwartz R, Avello E, Palisson F "Lamotrigine-induced toxic epidermal necrolysis treated with intravenous immunoglobulin and amniotic membranes." Arch Dermatol 144 (2008): 724-6

20. Bowden CL, Calabrese JR, Ketter TA, Sachs GS, White RL, Thompson TR "Impact of lamotrigine and lithium on weight in obese and nonobese patients with bipolar I disorder." Am J Psychiatry 163 (2006): 1199-201

21. Avoni P, Contin M, Riva R, Albani F, Liguori R, Baruzzi A "Dysgeusia in epileptic patients treated with lamotrigine: Report of three cases." Neurology 57 (2001): 1521

22. FDA. U.S Food & Drug Administration "FDA Drug Safety Communication: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal) Available from: URL: https://www.fda.gov/Drugs/DrugSafety/ucm605470.htm?utm_campaign=New%20FDA%20Drug%20Safety%20Comm" ([2018, Apr 25]):

23. Esfahani FE, Dasheiff RM "Anemia associated with lamotrigine." Neurology 49 (1997): 306-7

24. Fadul CE, Meyer LP, Jobst BC, Cornell CJ, Lewis LD "Agranulocytosis Associated with Lamotrigine in a Patient with Low-grade Glioma." Epilepsia 43 (2002): 199-200

25. Ouellet G, Tremblay L, Marleau D "Fulminant hepatitis induced by lamotrigine." South Med J 102 (2009): 82-4

26. Moeller KE, Wei L, Jewell AD, Carver LA "Acute hepatotoxicity associated with lamotrigine." Am J Psychiatry 165 (2008): 539-40

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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