Lamictal ODT Side Effects

Generic Name: lamotrigine

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

Not all side effects for Lamictal ODT may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

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

In addition to its needed effects, some unwanted effects may be caused by lamotrigine (the active ingredient contained in Lamictal ODT). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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
  • dark-colored urine
  • fever
  • flu-like symptoms
  • itching
  • memory loss
  • muscle cramps, pain, or weakness
  • red or irritated eyes
  • 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 with breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • 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 or hoarseness
  • coughing or vomiting blood
  • difficulty with breathing
  • difficulty with swallowing
  • fainting
  • fast heartbeat
  • general body swelling
  • general feeling of discomfort or illness
  • general feeling of tiredness or weakness
  • heartburn
  • high fever
  • lightheadedness
  • loss of appetite
  • 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
  • shortness of breath
  • 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
  • wheezing

If any of the following symptoms of overdose occur while taking lamotrigine, get emergency help immediately:

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

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

More common
  • Dizziness
  • drowsiness
  • headache
  • nausea
  • vomiting
Less common
  • Diarrhea
  • indigestion
  • loss of strength
  • menstrual pain
  • pain
  • runny nose
  • 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

Hypersensitivity

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 (the active ingredient contained in Lamictal ODT) 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.[Ref]

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.[Ref]

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. Two cases of aseptic meningitis have been reported. Exacerbation of Parkinsonian symptoms in patients with preexisting Parkinson's disease/tics has also been reported.[Ref]

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.[Ref]

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.[Ref]

Gastrointestinal

Gastrointestinal side effects including nausea (19%), vomiting (9%), diarrhea (6%), dyspepsia (5%), constipation (4%), tooth disorder (3%), anorexia (2%), pancreatitis, and esophagitis have been reported.[Ref]

Respiratory

Respiratory side effects including rhinitis (14%), pharyngitis (10%), increased cough (8%), and apnea have been reported. A case of interstitial pneumonitis has also been reported.[Ref]

Dermatologic

Dermatologic side effects including rash (10%) and pruritus (3%) have been reported. Alopecia has been reported rarely. A case of toxic epidermal necrolysis has also been reported.[Ref]

Genitourinary

Genitourinary side effects including dysmenorrhea (7%), vaginitis (4%), and amenorrhea (2%) have been reported.[Ref]

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 (the active ingredient contained in Lamictal ODT) [Ref]

Metabolic

Metabolic side effects including edema (2%) have been reported.[Ref]

Musculoskeletal

Musculoskeletal side effects including arthralgia (2%) have been reported.[Ref]

Cardiovascular

Cardiovascular side effects including hemorrhage have been reported.[Ref]

Hematologic

Hematologic side effects including hemolytic anemia and agranulocytosis have been reported.[Ref]

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.[Ref]

Hepatic

Hepatic side effects have been reported including a case of acute hepatotoxicity (in the absence of other medications) and a case of fulminant hepatitis that occurred two weeks after introduction of lamotrigine (the active ingredient contained in Lamictal ODT) [Ref]

Immunologic

Immunologic side effects including lupus-like reaction, vasculitis, and progressive immunosuppression have been reported.

References

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

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

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

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

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

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

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

8. 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

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

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

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

12. Sahin S, Comert A, Akin O, Ayalp S, Karsidag S "Cutaneous drug eruptions by current antiepileptics: case reports and alternative treatment options." Clin Neuropharmacol 31 (2008): 93-6

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

14. 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

15. 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

16. Sadler M "Lamotrigine associated with insomnia." Epilepsia 40 (1999): 322-5

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

18. 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

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

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

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

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

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

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

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