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Lamictal XR Side Effects

Generic name: lamotrigine

Medically reviewed by Drugs.com. Last updated on Sep 13, 2021.

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.

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 tablets conventional, oral tablets extended-release film-coated, oral tablets for oral suspension, oral tablets orally disintegrating

Warning

    Serious Skin Rashes
  • Risk of serious and potentially life-threatening rash, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and/or rash-related death.1 6 9 11 43 (See Serious Skin Rash under Cautions.)

  • Risk of serious rash is greater in pediatric patients than in adults (see Pediatric Use under Cautions) and may be increased by concomitant use of valproate (including valproic acid and divalproex sodium)1 43 or by exceeding the recommended initial dosage or dosage escalation schedule for lamotrigine.1 5 9 43

  • Cases of life-threatening rash associated with immediate-release lamotrigine almost always have occurred within 2–8 weeks of treatment initiation;1 43 however, isolated cases have been reported following prolonged treatment (e.g., 6 months).1 43

  • Can also cause benign rashes; however, it is not possible to predict which rashes will become serious or life-threatening.1 43 Discontinue therapy at the first sign of rash (unless the rash is clearly not drug related).1 43

  • Discontinuance of therapy may not prevent rash from becoming life-threatening or permanently disabling or disfiguring.1 43

Side effects include:

Immediate-release lamotrigine (the active ingredient contained in Lamictal XR) as adjunctive anticonvulsant therapy in adults: dizziness, headache, diplopia, ataxia, nausea, blurred vision, somnolence, rhinitis, pharyngitis, rash. Additional adverse effects reported in children: vomiting, infection, fever, accidental injury, diarrhea, abdominal pain, tremor.

Extended-release lamotrigine as adjunctive anticonvulsant therapy in adults and children ≥13 years of age: dizziness, tremor/intention tremor, vomiting, diplopia.

Immediate-release lamotrigine in adults with bipolar disorder: nausea, insomnia, somnolence, back pain, fatigue, rash, rhinitis, abdominal pain, xerostomia.

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

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]

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

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[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

Uncommon (0.1% to 1%): Leukopenia

Rare (less than 0.1%): Anemia, eosinophilia, fibrin decrease, fibrinogen decrease, iron deficiency anemia, leukocytosis, lymphocytosis, macrocytic anemia, ecchymosis, thrombocytopenia

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]

Frequently asked questions

References

1. "Product Information. LaMICtal XR (lamotrigine)." GlaxoSmithKline (2018):

2. "Product Information. Lamictal (lamotrigine)." Glaxo Wellcome (2001):

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

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

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

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

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

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

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

10. 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

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

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

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

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

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

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. 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

21. 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

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) https://www.fda.gov/Drugs/DrugSafety/ucm605470.htm?utm_campaign=New%20FDA%20Drug%20Safety%20Communication%20on%20Lam" (2018):

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

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

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.