Subvenite 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 dosage forms listed on this page may not apply to the brand name Subvenite.
Common side effects of Subvenite include: ataxia, skin rash, headache, insomnia, and nausea. Other side effects include: infection, dyspepsia, abnormal gait, constipation, and drowsiness. Continue reading for a comprehensive list of adverse effects.
Applies to lamotrigine: oral tablets conventional, oral tablets extended-release film-coated, oral tablets for oral suspension, oral tablets orally disintegrating.
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 Subvenite) 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.
For Healthcare Professionals
Applies to lamotrigine: oral tablet, oral tablet disintegrating, oral tablet dispersible, oral tablet extended release.
The more commonly reported adverse reactions have included dizziness, headache, diplopia, ataxia, nausea, blurred vision, somnolence, and rash.[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]
Uncommon (0.1% to 1%): Allergic reaction, chills, malaise[Ref]
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
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]
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
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]
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
Very common (10% or more): Vomiting (20%), nausea (19%), diarrhea (10%)
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]
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%)
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]
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]
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]
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
Postmarketing reports: Rhabdomyolysis (among patients experiencing hypersensitivity reactions)[Ref]
Common (1% to 10%): Chest pain, migraine
Uncommon (0.1% to 1%): Leukopenia
Common (1% to 10%): Lymphadenopathy
Uncommon (0.1% to 1%): Liver function tests abnormal, aspartate transaminase (AST) increased
Frequently asked questions
- Is it better to take lamotrigine at night?
- If you are taking lamotrigine how long does it take to get out of your system?
More about Subvenite (lamotrigine)
- Check interactions
- Pricing & coupons
- Imprints, shape & color data
- Latest FDA alerts (6)
- Dosage information
- During pregnancy or Breastfeeding
- En español
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
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.