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.

Some side effects of Lamictal XR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

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

Get emergency medical help if you have any of these signs of an allergic reaction while taking lamotrigine (the active ingredient contained in Lamictal XR) hives; fever; swollen glands; painful sores in or around your eyes or mouth; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Lamotrigine may cause severe or life-threatening skin rash, especially in children and in people who take too high of a dose at the start of treatment with lamotrigine. Serious skin rash may also be more likely to occur if you are taking lamotrigine together with valproic acid (Depakene) or divalproex (Depakote). Seek emergency medical attention if you have a fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

If you have to stop taking lamotrigine because of a serious skin rash, you may not be able to take it again in the future.

Call your doctor at once if you have any of these other serious side effects:

• the first sign of any skin rash, no matter how mild;

• fever, swollen glands, body aches, flu symptoms, headache, neck stiffness, increased sensitivity to light;

• easy bruising or bleeding, severe tingling, numbness, pain, muscle weakness;

• upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);

• chest pain, irregular heart rhythm, feeling short of breath;

• confusion, nausea and vomiting, swelling, rapid weight gain, urinating less than usual or not at all;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

• increased seizures or worsening of your bipolar disorder.

Less serious side effects of lamotrigine may include:

• tremors, dizziness, tired feeling;

• blurred vision, double vision;

• loss of coordination;

• dry mouth, mild nausea, stomach pain, upset stomach;

• changes in your menstrual periods;

• back pain;

• sleep problems (insomnia); or

• runny nose, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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 XR) 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.

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.

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.

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

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.

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.

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 (the active ingredient contained in Lamictal XR)

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 including hemolytic anemia and agranulocytosis have 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.

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 XR)

Immunologic

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

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