"March 4, 2010 -- One of the oldest drugs used to treat the most common form of pediatric epilepsy is also the most effective, a study shows.
As many as 17% of children with epilepsy have absence seizures, also known as petit mal seizure"...
Lamictal XR Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Lamictal XR (lamotrigine) is used alone or in combination with other medications to treat seizures in adults and children who are at least 2 years old. It is also used to delay mood episodes in adults with bipolar disorder. It is an anti-epileptic drug. Common side effects include dizziness, drowsiness, headache, blurred/double vision, lack of coordination, shaking (tremor), nausea, vomiting, diarrhea, or hot flashes.
Lamictal XR Extended-Release Tablets are taken once daily, with or without food. Tablets must be swallowed whole and must not be chewed, crushed, or divided. Consult your doctor for specific dosing. Lamictal XR may interact with hormonal forms of birth control (pills, injections, implants, or skin patches), carbamazepine, divalproex, oxcarbazepine, phenobarbital, primidone, phenytoin, rifampin, or valproic acid. Tell your doctor all medications you use. During pregnancy, Lamictal XR should be used only when prescribed. It may harm a fetus. Since untreated seizures are a serious condition that can harm both a pregnant woman and her fetus, do not stop taking this medication unless directed by your doctor. Consult your doctor about using this medication during pregnancy. Hormonal birth control may not work if taken with this medication; discuss birth control with your doctor. This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Our Lamictal XR (lamotrigine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Lamictal XR in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Lamictal XR (Lamotrigine Extended-Release Tablets) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Lamictal XR Overview - Patient Information: Side Effects
Dizziness, drowsiness, headache, blurred/double vision, lack of coordination, shaking (tremor), nausea, vomiting, diarrhea, or hot flushes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.
Tell your doctor immediately if any of these rare but very serious side effects occur: fainting, easy bruising/bleeding, stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine, signs of infection (such as fever, stiff neck, persistent sore throat), muscle pain/tenderness, change in the amount of urine, unusual tiredness, fast heartbeat.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Lamictal XR (Lamotrigine Extended-Release Tablets)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Lamictal XR FDA Prescribing Information: Side Effects
The following adverse reactions are described in more detail in the WARNINGS AND PRECAUTIONS section of the label:
- Serious skin rashes [see WARNINGS AND PRECAUTIONS]
- Multiorgan hypersensitivity reactions and organ failure [see WARNINGS AND PRECAUTIONS]
- Blood dyscrasias [see WARNINGS AND PRECAUTIONS]
- Suicidal behavior and ideation [see WARNINGS AND PRECAUTIONS]
- Aseptic meningitis [see WARNINGS AND PRECAUTIONS]
- Withdrawal seizures [see WARNINGS AND PRECAUTIONS]
- Status epilepticus [see WARNINGS AND PRECAUTIONS]
- Sudden unexplained death in epilepsy [see WARNINGS AND PRECAUTIONS]
Clinical Trial Experience With LAMICTAL XR For Treatment Of Primary Generalized Tonic-Clonic And Partial-Onset Seizures
Most Common Adverse Reactions in Clinical Trials
Adjunctive Therapy in Patients With Epilepsy: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
LAMICTAL XR has been evaluated for safety in patients aged 13 years and older with PGTC and partial-onset seizures. The most commonly observed adverse reactions in these 2 double-blind, placebo-controlled trials of adjunctive therapy with LAMICTAL XR were, in order of decreasing incidence (treatment difference between LAMICTAL XR and placebo ≥ 4%): dizziness, tremor/intention tremor, vomiting, and diplopia.
In these 2 trials, adverse reactions led to withdrawal of 4 (2%) patients in the group receiving placebo and 10 (5%) patients in the group receiving LAMICTAL XR. Dizziness was the most common reason for withdrawal in the group receiving LAMICTAL XR (5 patients [3%]). The next most common adverse reactions leading to withdrawal in 2 patients each (1%) were rash, headache, nausea, and nystagmus.
Table 4 displays the incidence of adverse reactions in these two 19-week, double-blind, placebo-controlled trials of patients with PGTC and partial onset seizures.
Table 4: Adverse Reaction Incidence in Double-Blind,
Placebo-Controlled Adjunctive Trials in Patients With Epilepsy (Adverse
reactions ≥ 2% of patients treated with LAMICTAL XR and numerically more
frequent than in the placebo group.)
|Body System/Adverse Reaction||Percent of Patients Receiving Adjunctive LAMICTAL XR
(n = 190)
|Percent of Patients Receiving Adjunctive Placebo
(n = 195)
|Ear and labyrinth disorders|
|General disorders and administration site conditions|
|Asthenia and fatigue||6||4|
|Infections and infestations|
|Metabolic and nutritional disorders|
|Musculoskeletal and connective tissue disorder|
|Tremor and intention tremor||6||1|
|Cerebellar coordination and balance disorder||3||0|
|Respiratory, thoracic, and mediastinal disorders|
Note: In these trials the incidence of nonserious rash was 2% for LAMICTAL XR and 3% for placebo. In clinical trials evaluating immediate-release lamotrigine, the rate of serious rash was 0.3% in adults on adjunctive therapy for epilepsy [see BOXED WARNING].
Adverse reactions were also analyzed to assess the incidence of the onset of an event in the titration period, and in the maintenance period, and if adverse reactions occurring in the titration phase persisted in the maintenance phase.
The incidence for many adverse reactions caused by treatment with LAMICTAL XR was increased relative to placebo (i.e., treatment difference between LAMICTAL XR and placebo ≥ 2%) in either the titration or maintenance phases of the trial. During the titration phase, an increased incidence (shown in descending order of % treatment difference) was observed for diarrhea, nausea, vomiting, somnolence, vertigo, myalgia, hot flush, and anxiety. During the maintenance phase, an increased incidence was observed for dizziness, tremor, and diplopia. Some adverse reactions developing in the titration phase were notable for persisting ( > 7 days) into the maintenance phase. These persistent adverse reactions included somnolence and dizziness.
There were inadequate data to evaluate the effect of dose and/or concentration on the incidence of adverse reactions because, although patients were randomized to different target doses based upon concomitant AEDs, the plasma exposure was expected to be generally similar among all patients receiving different doses. However, in a randomized, parallel trial comparing placebo with 300 and 500 mg/day of immediate-release lamotrigine, the incidence of the most common adverse reactions ( ≥ 5%) such as ataxia, blurred vision, diplopia, and dizziness were dose related. Less common adverse reactions ( < 5%) were not assessed for dose-response relationships.
Monotherapy in Patients With Epilepsy: Adverse reactions observed in this trial were generally similar to those observed and attributed to drug in adjunctive and monotherapy immediate-release lamotrigine and adjunctive LAMICTAL XR placebo-controlled trials. Only 2 adverse events, nasopharyngitis and upper respiratory tract infection, were observed at a rate of ≥ 3% and not reported at a similar rate in previous trials. Because this trial did not include a placebo control group, causality could not be established [see Clinical Studies].
Other Adverse Reactions Observed During The Clinical Development Of Immediate-Release Lamotrigine
All reported reactions are included except those already listed in the previous tables or elsewhere in the labeling, those too general to be informative, and those not reasonably associated with the use of the drug.
Adjunctive Therapy in Adults With Epilepsy
In addition to the adverse reactions reported above from the development of LAMICTAL XR, the following adverse reactions with an uncertain relationship to lamotrigine were reported during the clinical development of immediate-release lamotrigine for treatment of epilepsy in adults. These reactions occurred in ≥ 2% of patients receiving immediate-release lamotrigine and more frequently than in the placebo group.
Body as a Whole: Headache, flu syndrome, fever, neck pain.
Respiratory: Pharyngitis, cough increased.
Skin and Appendages: Rash, pruritus.
Monotherapy in Adults With Epilepsy
In addition to the adverse reactions reported above from the development of LAMICTAL XR, the following adverse reactions with an uncertain relationship to lamotrigine were reported during the clinical development of immediate-release lamotrigine for treatment of epilepsy in adults. These reactions occurred in > 2% of patients receiving immediate-release lamotrigine and more frequently than in the placebo group.
Body as a Whole: Chest pain.
Metabolic and Nutritional: Weight decrease, peripheral edema.
Nervous: Hypesthesia, libido increase, decreased reflexes.
Skin and Appendages: Contact dermatitis, dry skin, sweating.
Special Senses: Vision abnormality.
Urogenital (female patients only): Dysmenorrhea.
Other Clinical Trial Experience
Immediate-release lamotrigine has been administered to 6,694 individuals for whom complete adverse reaction data was captured during all clinical trials, only some of which were placebo controlled.
Adverse reactions are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse reactions are defined as those occurring in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1,000 patients; rare adverse reactions are those occurring in fewer than 1/1,000 patients.
Hematologic and Lymphatic System: Infrequent: Ecchymosis, leukopenia. Rare: Anemia, eosinophilia, fibrin decrease, fibrinogen decrease, iron deficiency anemia, leukocytosis, lymphocytosis, macrocytic anemia, petechia, thrombocytopenia.
Metabolic and Nutritional Disorders: Infrequent: Aspartate transaminase increased. Rare: Alcohol intolerance, alkaline phosphatase increase, alanine transaminase increase, bilirubinemia, gamma glutamyl transpeptidase increase, hyperglycemia.
Musculoskeletal System: Rare: Muscle atrophy, pathological fracture, tendinous contracture.
Nervous System: Frequent: Confusion. Infrequent: Akathisia, apathy, aphasia, depersonalization, dysarthria, dyskinesia, euphoria, hallucinations, hostility, hyperkinesia, hypertonia, libido decreased, memory decrease, mind racing, movement disorder, myoclonus, panic attack, paranoid reaction, personality disorder, psychosis, stupor. Rare: Choreoathetosis, delirium, delusions, dysphoria, dystonia, extrapyramidal syndrome, hemiplegia, hyperalgesia, hyperesthesia, hypokinesia, hypotonia, manic depression reaction, neuralgia, paralysis, peripheral neuritis.
Respiratory System: Rare: Hiccup, hyperventilation.
Special Senses: Frequent: Amblyopia. Infrequent: Abnormality of accommodation, conjunctivitis, dry eyes, ear pain, photophobia, taste perversion, tinnitus. Rare: Deafness, lacrimation disorder, oscillopsia, parosmia, ptosis, strabismus, taste loss, uveitis, visual field defect.
Urogenital System: Infrequent: Abnormal ejaculation, hematuria, impotence, menorrhagia, polyuria, urinary incontinence. Rare: Acute kidney failure, breast neoplasm, creatinine increase, female lactation, kidney failure, kidney pain, nocturia, urinary retention, urinary urgency.
Postmarketing Experience With Immediate-Release Lamotrigine
The following adverse events (not listed above in clinical trials or other sections of the prescribing information) have been identified during postapproval use of immediate-release lamotrigine. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hepatobiliary Tract and Pancreas: Pancreatitis.
Lower Respiratory: Apnea.
Musculoskeletal: Rhabdomyolysis has been observed in patients experiencing hypersensitivity reactions.
Neurology: Exacerbation of Parkinsonian symptoms in patients with pre-existing Parkinson's disease, tics.
Non-site Specific: Progressive immunosuppression.
Read the entire FDA prescribing information for Lamictal XR (Lamotrigine Extended-Release Tablets) »
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