Lamictal XR Side Effects Center

Last updated on RxList: 4/8/2021
Lamictal XR Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Lamictal XR?

Lamictal XR (lamotrigine) is an anti-epileptic drug used alone or in combination with other medications to treat seizures in adults and children who are at least 2 years old. Lamictal XR is also used to delay mood episodes in adults with bipolar disorder.

What Are Side Effects of Lamictal XR?

Common side effects of Lamictal XR include:

Dosage for Lamictal XR

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.

What Drugs, Substances, or Supplements Interact with Lamictal XR?

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.

Lamictal XR During Pregnancy and Breastfeeding

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 breastfeeding.

Additional Information

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 Epilepsy? Symptoms, Causes, and Treatments See Slideshow
Lamictal XR Consumer Information

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Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with 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.

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.

Call your doctor at once if you have:

  • fast, slow, or pounding heartbeats or fluttering in your chest;
  • chest pain, shortness of breath;
  • fever, swollen glands, weakness, severe muscle pain;
  • any skin rash, especially with blistering or peeling;
  • painful sores in your mouth or around your eyes;
  • headache, neck stiffness, increased sensitivity to light, nausea, vomiting, confusion, drowsiness;
  • jaundice (yellowing of the skin or eyes); or
  • pale skin, cold hands and feet, easy bruising, unusual bleeding.

Common side effects may include:

  • headache, dizziness;
  • blurred vision, double vision;
  • tremor, loss of coordination;
  • dry mouth, nausea, vomiting, stomach pain, diarrhea;
  • fever, sore throat, runny nose;
  • drowsiness, tired feeling;
  • back pain; or
  • sleep problems (insomnia).

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.


If you have had a seizure, it means you have epilepsy. See Answer
Lamictal XR Professional Information


The following adverse reactions are described in more detail in the WARNINGS AND PRECAUTIONS section of the label:

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.

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 Reactions in Pooled, Placebo-Controlled, Adjunctive Trials in Patients With Epilepsya

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
  Vertigo 3 < 1
Eye disorders
  Diplopia 5 < 1
  Vision blurred 3 2
Gastrointestinal disorders
  Nausea 7 4
  Vomiting 6 3
  Diarrhea 5 3
  Constipation 2 < 1
  Dry mouth 2 1
General disorders and administration site conditions
  Asthenia and fatigue 6 4
Infections and infestations
  Sinusitis 2 1
Metabolic and nutritional disorders
  Anorexia 3 2
Musculoskeletal and connective tissue disorder
  Myalgia 2 0
Nervous system
  Dizziness 14 6
  Tremor and intention tremor 6 1
  Somnolence 5 3
  Cerebellar coordination and balance disorder 3 0
  Nystagmus 2 < 1
Psychiatric disorders
  Depression 3 < 1
  Anxiety 3 0
Respiratory, thoracic, and mediastinal disorders
  Pharyngolaryngeal pain 3 2
Vascular disorder
  Hot flush 2 0
aAdverse reactions that occurred in at least 2% of patients treated with LAMICTAL XR and at a greater incidence than placebo.

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.

Musculoskeletal: Arthralgia.

Nervous: Insomnia, convulsion, irritability, speech disorder, concentration disturbance.

Respiratory: Pharyngitis, cough increased.

Skin and Appendages: Rash, pruritus.

Urogenital (female patients only): Vaginitis, amenorrhea, dysmenorrhea.

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.

Digestive: Rectal hemorrhage, peptic ulcer.

Metabolic and Nutritional: Weight decrease, peripheral edema.

Nervous: Hypesthesia, libido increase, decreased reflexes.

Respiratory: Epistaxis, dyspnea.

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.

Cardiovascular System: Infrequent: Hypertension, palpitations, postural hypotension, syncope, tachycardia, vasodilation.

Dermatological: Infrequent: Acne, alopecia, hirsutism, maculopapular rash, urticaria. Rare: Leukoderma, multiforme erythema, petechial rash, pustular rash.

Digestive System: Infrequent: Dysphagia, liver function tests abnormal, mouth ulceration. Rare: Gastrointestinal hemorrhage, hemorrhagic colitis, hepatitis, melena and stomach ulcer.

Endocrine System: Rare: Goiter, hypothyroidism.

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.

Blood and Lymphatic

Agranulocytosis, hemolytic anemia, lymphadenopathy not associated with hypersensitivity disorder.



Hepatobiliary Tract and Pancreas



Lupus-like reaction, vasculitis.

Lower Respiratory



Rhabdomyolysis has been observed in patients experiencing hypersensitivity reactions.

Nervous System

Aggression, 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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© Lamictal XR Patient Information is supplied by Cerner Multum, Inc. and Lamictal XR Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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