Does Lamictal (lamotrigine) cause side effects?
It is also prescribed for individuals over the age of 18 for the prevention of mood episodes in individuals with bipolar disorder. It is chemically unrelated to other anti-seizure drugs. The precise mechanism by which Lamictal exerts its anti-seizure action is not known.
Common side effects of Lamictal include
Serious side effects of Lamictal include
- severe, life-threatening rashes;
- increased risk of developing aseptic meningitis;
- reduced white blood cells, red blood cells, and platelets;
- suicidal thoughts or behaviors; and rarely,
- multiorgan failure, including fatal liver disease.
Drug interactions of Lamictal include valproic acid, because the blood concentrations of valproic acid can decrease over a 3-week period. This may result in loss of seizure control. Valproic acid increases Lamictal levels.
The risk of severe skin rash may be increased by combining Lamictal with valproic acid.
Estrogen containing oral contraceptives, phenobarbital, primidone, phenytoin, and rifampin reduce the blood levels of Lamictal by 40%-50% by increasing the breakdown of Lamictal in the liver. This may result in reduced efficacy if the dose of Lamictal is not adjusted.
Use of Lamictal during pregnancy has not been adequately evaluated. Lamictal is secreted into breast milk. Because the effects on the infant are unknown, breastfeeding while taking Lamictal is not recommended.
What are the important side effects of Lamictal (lamotrigine)?
Severe, life-threatening rashes have occurred with lamotrigine. The risk of rash is increased if the dose is increased faster than recommended or if patients also are taking valproic acid. Patients taking lamotrigine should report any rash to a physician immediately, as there's no way to tell at the onset whether the rash will be mild or severe.
Common side effects
The most common side effects of lamotrigine are:
Other important side effects include:
- increased risk of developing aseptic meningitis and
- reduced white blood cells, red blood cells, and platelets.
- suicidal thoughts or behaviors
Multiorgan failure, including fatal liver disease rarely has been observed during lamotrigine treatment.
As a general rule, anti-seizure medications should not be abruptly stopped because of the possibility of increasing the frequency of seizures. In most cases, the dose of lamotrigine should be gradually lowered over a period of at least two weeks.
Antiepileptic medications have been associated with an increased risk of suicidal thinking and behavior. Anyone considering the use of antiepileptic drugs must balance this risk of suicide with the clinical need for the drugs.
Patients who are started on therapy should be closely observed for clinical worsening, suicidal thoughts, or unusual changes in behavior.
Lamictal (lamotrigine) side effects list for healthcare professionals
The following serious adverse reactions are described in more detail in the Warnings and Precautions section of the labeling:
- Serious Skin Rashes
- Hemophagocytic Lymphohistiocytosis
- Multiorgan Hypersensitivity Reactions and Organ Failure
- Blood Dyscrasias
- Suicidal Behavior and Ideation
- Aseptic Meningitis
- Withdrawal Seizures
- Status Epilepticus
- Sudden Unexplained Death in Epilepsy
Clinical Trial Experience
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.
Most Common Adverse Reactions In All Clinical Trials
Adjunctive Therapy in Adults with Epilepsy: The most commonly observed (=5% for Lamictal and more common on drug than placebo) adverse reactions seen in association with Lamictal during adjunctive therapy in adults and not seen at an equivalent frequency among placebo-treated patients were:
Dizziness, diplopia, ataxia, blurred vision, nausea, and vomiting were dose related. Dizziness, diplopia, ataxia, and blurred vision occurred more commonly in patients receiving carbamazepine with Lamictal than in patients receiving other AEDs with Lamictal. Clinical data suggest a higher incidence of rash, including serious rash, in patients receiving concomitant valproate than in patients not receiving valproate.
Approximately 11% of the 3,378 adult patients who received Lamictal as adjunctive therapy in premarketing clinical trials discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with discontinuation were
- rash (3.0%),
- dizziness (2.8%), and
- headache (2.5%).
In a dose-response trial in adults, the rate of discontinuation of Lamictal for
- blurred vision,
- nausea, and
- vomiting was dose related.
Monotherapy In Adults With Epilepsy
The most commonly observed (≥5% for Lamictal and more common on drug than placebo) adverse reactions seen in association with the use of Lamictal during the monotherapy phase of the controlled trial in adults not seen at an equivalent rate in the control group were
- coordination abnormality,
- weight decrease,
- chest pain, and
The most commonly observed (≥5% for Lamictal and more common on drug than placebo) adverse reactions associated with the use of Lamictal during the conversion to monotherapy (add-on) period, not seen at an equivalent frequency among low-dose valproate-treated patients, were
- coordination abnormality,
- accidental injury,
- blurred vision,
- pruritus, and
Approximately 10% of the 420 adult patients who received Lamictal as monotherapy in premarketing clinical trials discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with discontinuation were
- rash (4.5%),
- headache (3.1%), and
- asthenia (2.4%).
Adjunctive Therapy In Pediatric Patients With Epilepsy
The most commonly observed (≥5% for Lamictal and more common on drug than placebo) adverse reactions seen in association with the use of Lamictal as adjunctive treatment in pediatric patients aged 2 to 16 years and not seen at an equivalent rate in the control group were
- accidental injury,
- abdominal pain,
- flu syndrome, and
In 339 patients aged 2 to 16 years with partial-onset seizures or generalized seizures of Lennox-Gastaut syndrome, 4.2% of patients on Lamictal and 2.9% of patients on placebo discontinued due to adverse reactions. The most commonly reported adverse reaction that led to discontinuation of Lamictal was rash.
Approximately 11.5% of the 1,081 pediatric patients aged 2 to 16 years who received Lamictal as adjunctive therapy in premarketing clinical trials discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with discontinuation were
- rash (4.4%),
- reaction aggravated (1.7%), and
- ataxia (0.6%).
Controlled Adjunctive Clinical Trials In Adults With Epilepsy
Table 8 lists adverse reactions that occurred in adult patients with epilepsy treated with Lamictal in placebo-controlled trials. In these trials, either Lamictal or placebo was added to the patient's current AED therapy.
Table 8: Adverse Reactions in Pooled, Placebo-Controlled Adjunctive Trials in Adult Patients with Epilepsy a,b
|Body System/ Adverse Reaction||Percent of Patients Receiving Adjunctive Lamictal|
(n = 711)
|Percent of Patients Receiving Adjunctive Placebo|
(n = 419)
|Body as a whole|
|Reaction aggravated (seizure exacerbation)||2||1|
|Skin and appendages|
|Female patients only||(n = 365)||(n = 207)|
|a Adverse reactions that occurred in at least 2% of patients treated with Lamictal and at a greater incidence than placebo.|
b Patients in these adjunctive trials were receiving 1 to 3 of the concomitant antiepileptic drugs carbamazepine, phenytoin, phenobarbital, or primidone in addition to Lamictal or placebo. Patients may have reported multiple adverse reactions during the trial or at discontinuation; thus, patients may be included in more than 1 category.
In a randomized, parallel trial comparing placebo with 300 and 500 mg/day of Lamictal, some of the more common drug-related adverse reactions were dose related (see Table 9).
Table 9: Dose-Related Adverse Reactions from a Randomized, Placebo-Controlled, Adjunctive Trial in Adults with Epilepsy
|Adverse Reaction||Percent of Patients Experiencing Adverse Reactions|
(n = 73)
|Lamictal 300 mg|
(n = 71)
|Lamictal 500 mg|
(n = 72)
|a Significantly greater than placebo group (P<0.05).|
b Significantly greater than group receiving Lamictal 300 mg (P<0.05).
- The overall adverse reaction profile for Lamictal was similar between females and males and was independent of age.
- Because the largest non-Caucasian racial subgroup was only 6% of patients exposed to Lamictal in placebo-controlled trials, there are insufficient data to support a statement regarding the distribution of adverse reaction reports by race.
- Generally, females receiving either Lamictal as adjunctive therapy or placebo were more likely to report adverse reactions than males.
- The only adverse reaction for which the reports on Lamictal were >10% more frequent in females than males (without a corresponding difference by gender on placebo) was dizziness (difference = 16.5%).
- There was little difference between females and males in the rates of discontinuation of Lamictal for individual adverse reactions.
Controlled Monotherapy Trial In Adults With Partial-Onset Seizures
Table 10 lists adverse reactions that occurred in patients with epilepsy treated with monotherapy with Lamictal in a double-blind trial following discontinuation of either concomitant carbamazepine or phenytoin not seen at an equivalent frequency in the control group.
Table 10: Adverse Reactions in a Controlled Monotherapy Trial in Adult Patients with Partial-Onset Seizures a,b
|Body System/ Adverse Reaction||Percent of Patients Receiving Lamictalc as Monotherapy|
(n = 43)
|Percent of Patients Receiving Low-Dose Valproated Monotherapy|
(n = 44)
|Body as a whole|
|Metabolic and nutritional|
|Urogenital (female patients only)||(n = 21)||(n = 28)|
|a Adverse reactions that occurred in at least 5% of patients treated with Lamictal and at a greater incidence than valproate-treated patients.|
b Patients in this trial were converted to Lamictal or valproate monotherapy from adjunctive therapy with carbamazepine or phenytoin. Patients may have reported multiple adverse reactions during the trial; thus, patients may be included in more than 1 category.
c Up to 500 mg/day.
d 1,000 mg/day.
Adverse reactions that occurred with a frequency of <5% and >2% of patients receiving Lamictal and numerically more frequent than placebo were:
Body as a Whole: Asthenia, fever.
Metabolic and Nutritional: Peripheral edema.
Respiratory: Epistaxis, bronchitis, dyspnea.
Special Senses: Vision abnormality.
Incidence In Controlled Adjunctive Trials In Pediatric Patients With Epilepsy
Table 11 lists adverse reactions that occurred in 339 pediatric patients with partial-onset seizures or generalized seizures of Lennox-Gastaut syndrome who received Lamictal up to 15 mg/kg/day or a maximum of 750 mg/day.
Table 11: Adverse Reactions in Pooled, Placebo-Controlled, Adjunctive Trials in Pediatric Patients with Epilepsy a
|Body System/ Adverse Reaction||Percent of Patients Receiving Lamictal|
(n = 168)
|Percent of Patients Receiving Placebo|
(n = 171)
|Body as a whole|
|Hemic and lymphatic|
|Metabolic and nutritional|
|Urogenital Male and female patients|
|Urinary tract infection||3||0|
|a Adverse reactions that occurred in at least 2% of patients treated with Lamictal and at a greater incidence than placebo.|
Bipolar Disorder In Adults
The most common adverse reactions seen in association with the use of Lamictal as monotherapy (100 to 400 mg/day) in adult patients (aged 18 to 82 years) with bipolar disorder in the 2 double-blind, placebo-controlled trials of 18 months' duration are included in Table 12.
Adverse reactions that occurred in at least 5% of patients and were numerically more frequent during the dose-escalation phase of Lamictal in these trials (when patients may have been receiving concomitant medications) compared with the monotherapy phase were:
- headache (25%),
- rash (11%),
- dizziness (10%),
- diarrhea (8%),
- dream abnormality (6%), and
- pruritus (6%).
During the monotherapy phase of the double-blind, placebo-controlled trials of 18 months' duration, 13% of 227 patients who received Lamictal (100 to 400 mg/day), 16% of 190 patients who received placebo, and 23% of 166 patients who received lithium discontinued therapy because of an adverse reaction.
The adverse reactions that most commonly led to discontinuation of Lamictal were
Approximately 16% of 2,401 patients who received Lamictal (50 to 500 mg/day) for bipolar disorder in premarketing trials discontinued therapy because of an adverse reaction, most commonly due to
- rash (5%) and
- mania/hypomania/mixed mood adverse reactions (2%).
The overall adverse reaction profile for Lamictal was similar between females and males, between elderly and nonelderly patients, and among racial groups.
Table 12: Adverse Reactions in 2 Placebo-Controlled Trials in Adult Patients with Bipolar I Disordera,b
|Body System/ Adverse Reaction||Percent of Patients Percent of Patients|
(n = 227)
(n = 190)
|Xerostomia (dry mouth)||6||4|
|Exacerbation of cough||5||3|
|a Adverse reactions that occurred in at least 5% of patients treated with Lamictal and at a greater incidence than placebo.|
b Patients in these trials were converted to Lamictal (100 to 400 mg/day) or placebo monotherapy from add-on therapy with other psychotropic medications. Patients may have reported multiple adverse reactions during the trial; thus, patients may be included in more than 1 category.
c In the overall bipolar and other mood disorders clinical trials, the rate of serious rash was 0.08% (1 of 1,233) of adult patients who received Lamictal as initial monotherapy and 0.13% (2 of 1,538) of adult patients who received Lamictal as adjunctive therapy.
Other reactions that occurred in 5% or more patients but equally or more frequently in the placebo group included:
Adverse reactions that occurred with a frequency of <5% and >1% of patients receiving Lamictal and numerically more frequent than placebo were:
General: Fever, neck pain.
Metabolic and Nutritional: Weight gain, edema.
Urogenital: Urinary frequency.
Adverse Reactions Following Abrupt Discontinuation
- In the 2 controlled clinical trials, there was no increase in the incidence, severity, or type of adverse reactions in patients with bipolar disorder after abruptly terminating therapy with Lamictal.
- In the clinical development program in adults with bipolar disorder, 2 patients experienced seizures shortly after abrupt withdrawal of Lamictal.
- During the double-blind, placebo-controlled clinical trials in bipolar I disorder in which adults were converted to monotherapy with Lamictal (100 to 400-mg/day) from other psychotropic medications and followed for up to 18 months, the rates of manic or hypomanic or mixed mood episodes reported as adverse reactions were
- 5% for patients treated with Lamictal (n = 227),
- 4% for patients treated with lithium (n = 166), and
- 7% for patients treated with placebo (n = 190).
- In all bipolar controlled trials combined, adverse reactions of mania (including hypomania and mixed mood episodes) were reported in
- 5% of patients treated with Lamictal (n = 956),
- 3% of patients treated with lithium (n = 280), and
- 4% of patients treated with placebo (n = 803).
Other Adverse Reactions Observed In All Clinical Trials
- Lamictal 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.
- During these trials, all adverse reactions were recorded by the clinical investigators using terminology of their own choosing.
- To provide a meaningful estimate of the proportion of individuals having adverse reactions, similar types of adverse reactions were grouped into a smaller number of standardized categories using modified COSTART dictionary terminology.
- The frequencies presented represent the proportion of the 6,694 individuals exposed to Lamictal who experienced an event of the type cited on at least 1 occasion while receiving Lamictal.
- All reported adverse 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.
- 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.
Body As A Whole
Rare: Goiter, hypothyroidism.
Hematologic And Lymphatic System
Infrequent: Ecchymosis, leukopenia.
Metabolic And Nutritional Disorders
Infrequent: Aspartate transaminase increased.
Frequent: Confusion, paresthesia.
Infrequent: Akathisia, apathy, aphasia, central nervous system depression, depersonalization, dysarthria, dyskinesia, euphoria, hallucinations, hostility, hyperkinesia, hypertonia, libido decreased, memory decrease, mind racing, movement disorder, myoclonus, panic attack, paranoid reaction, personality disorder, psychosis, sleep disorder, stupor, suicidal ideation.
Rare: Choreoathetosis, delirium, delusions, dysphoria, dystonia, extrapyramidal syndrome, faintness, grand mal convulsions, hemiplegia, hyperalgesia, hyperesthesia, hypokinesia, hypotonia, manic depression reaction, muscle spasm, neuralgia, neurosis, paralysis, peripheral neuritis.
Infrequent: Yawn. Rare: Hiccup, hyperventilation. Special Senses
Rare: Acute kidney failure, anorgasmia, breast abscess, breast neoplasm, creatinine increase, cystitis, dysuria, epididymitis, female lactation, kidney failure, kidney pain, nocturia, urinary retention, urinary urgency.
The following adverse reactions have been identified during postapproval use of Lamictal. Because these reactions 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
Rhabdomyolysis has been observed in patients experiencing hypersensitivity reactions.
What drugs interact with Lamictal (lamotrigine)?
Significant drug interactions with Lamictal are summarized in this section.
Uridine 5´-diphospho-glucuronyl transferases (UGT) have been identified as the enzymes responsible for metabolism of lamotrigine. Drugs that induce or inhibit glucuronidation may, therefore, affect the apparent clearance of lamotrigine.
Strong or moderate inducers of the cytochrome P450 3A4 (CYP3A4) enzyme, which are also known to induce UGT, may also enhance the metabolism of lamotrigine.
Those drugs that have been demonstrated to have a clinically significant impact on lamotrigine metabolism are outlined in Table 13. Specific dosing guidance for these drugs is provided in the Dosage and Administration section.
Additional details of these drug interaction studies are provided in the Clinical Pharmacology section.
Table 13: Established and Other Potentially Significant Drug Interactions
|Concomitant Drug||Effect on Concentration of Lamotrigine or Concomitant Drug||Clinical Comment|
|Estrogen-containing oral contraceptive preparations containing 30 mcg ethinylestradiol and 150 mcg levonorgestrel||↓ lamotrigine||Decreased lamotrigine concentrations approximately 50%.|
|↓ levonorgestrel||Decrease in levonorgestrel component by 19%.|
|Carbamazepine and carbamazepine epoxide||↓ lamotrigine||Addition of carbamazepine decreases lamotrigine concentration approximately 40%.|
|? carbamazepine epoxide||May increase carbamazepine epoxide levels.|
|Lopinavir/ritonavir||↓ lamotrigine||Decreased lamotrigine concentration approximately 50%.|
|Atazanavir/ritonavir||↓ lamotrigine||Decreased lamotrigine AUC approximately 32%.|
|Phenobarbital/primidone||↓ lamotrigine||Decreased lamotrigine concentration approximately 40%.|
|Phenytoin||↓ lamotrigine||Decreased lamotrigine concentration approximately 40%.|
|Rifampin||↓ lamotrigine||Decreased lamotrigine AUC approximately 40%.|
|Valproate||↑ lamotrigine||Increased lamotrigine concentrations slightly more than 2-fold.|
|? valproate||There are conflicting study results regarding effect of lamotrigine on valproate concentrations: 1) a mean 25% decrease in valproate concentrations in healthy volunteers, 2) no change in valproate concentrations in controlled clinical trials in patients with epilepsy.|
|↓ = Decreased (induces lamotrigine glucuronidation).|
↑ = Increased (inhibits lamotrigine glucuronidation).
? = Conflicting data.
Effect Of Lamictal On Organic Cationic Transporter 2 Substrates
Lamotrigine is an inhibitor of renal tubular secretion via organic cationic transporter 2 (OCT2) proteins. This may result in increased plasma levels of certain drugs that are substantially excreted via this route.
Coadministration of Lamictal with OCT2 substrates with a narrow therapeutic index (e.g., dofetilide) is not recommended.
Lamictal (lamotrigine) is an anti-seizure medication used in combination with other anti-seizure drugs for the treatment of partial seizures, and tonic-clonic seizures of Lennox-Gastaut syndrome. Common side effects of Lamictal include dizziness, drowsiness, headache, double vision, blurred vision, nausea, vomiting, and rash. Use of Lamictal during pregnancy has not been adequately evaluated. Lamictal is secreted into breast milk. Because the effects on the infant are unknown, breastfeeding while taking Lamictal is not recommended.
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Migraines are a type of headache and seizures are the main symptom of epilepsy. Migraine headaches and seizures are two different neurological problems that have similar signs, symptoms, and auras, for example, sensitivity to light (photophobia) and sound, irritability, nausea, and vomiting. Symptoms unique to migraine and migraine auras are water retention, problems sleeping, appetite changes, and talkativeness. Symptoms unique to seizure and seizures auras are depression, a feeling of heaviness, a feeling that a seizure is approaching, and depression. Many of the symptoms of migraine and seizures are the same, however, seizures do not cause migraines; however, people who have seizures are twice as likely to have migraines and vice-versa. People who have migraines are twice as likely to have seizures, and people with seizures are twice as likely to have migraines; however, one condition does not cause the other.
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Febrile seizures, or convulsions caused by fever, can be frightening in small children or infants. However, in general, febrile seizures are harmless. Febrile seizure is not epilepsy. It is estimated that one in every 25 children will have at least one febrile seizure. It is important to know what to do to help your child if he/she has a febrile seizure. Some of the features of a febrile seizure include losing consciousness, shaking, moving limbs on both sides of the body, and lasts 1-2 minutes. Less commonly, a febrile seizure may only affect one side of the body.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.