Lamictal Adverse Reactions

The adverse reactions identified from epilepsy or bipolar disorder clinical trial data have been divided into indication specific sections. Additional adverse reactions identified through post-marketing surveillance for both indications are included in the post-marketing section. All three sections should be consulted when considering the overall safety profile of Lamictal.
The following convention has been utilised for the classification of undesirable effects: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Epilepsy: The following adverse reactions were identified during epilepsy clinical trials and should be considered alongside those seen in the bipolar disorder clinical trials and post-marketing sections for an overall safety profile of Lamictal.
Skin and Subcutaneous Tissue Disorders: Very Common: Skin rash. Rare: Stevens-Johnson syndrome. Very rare: Toxic epidermal necrolysis.
In double-blind, add-on clinical trials in adults, skin rashes occurred in up to 10% of patients taking Lamictal and in 5% of patients taking placebo. The skin rashes led to the withdrawal of Lamictal treatment in 2% of patients. The rash, usually maculopapular in appearance, generally appears within eight weeks of starting treatment and resolves on withdrawal of Lamictal (see Precautions).
Rarely, serious potentially life-threatening skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome) have been reported. Although the majority recover on drug withdrawal, some patients experience irreversible scarring and there have been rare cases of associated death (see Precautions).
The overall risk of rash appears to be strongly associated with: high initial doses of Lamictal and exceeding the recommended dose escalation of Lamictal therapy (see Dosage & Administration); concomitant use of valproate (see Dosage & Administration).
Rash has also been reported as part of drug reaction with eosinophilia and systemic symptoms (DRESS); also known as hypersensitivity syndrome. This condition is associated with a variable pattern of systemic symptoms (see Precautions and Immune system disorders in the following text).
Blood and Lymphatic System Disorders: Very Rare: Haematological abnormalities (including, neutropenia, leucopenia, anaemia, thrombocytopenia, pancytopenia, aplastic anaemia, agranulocytosis), lymphadenopathy.
Haematological abnormalities and lymphadenopathy may or may not be associated with DRESS/hypersensitivity syndrome (see Precautions and Immune system disorders in the following text).
Immune System Disorders: Very Rare: DRESS/Hypersensitivity syndrome** including such symptoms as, fever, lymphadenopathy, facial oedema, abnormalities of the blood, liver and kidney.
**Rash has also been reported as part of this syndrome which shows a wide spectrum of clinical severity and may, rarely, lead to disseminated intravascular coagulation (DIC) and multiorgan failure. It is important to note that early manifestations of hypersensitivity (e.g. fever, lymphadenopathy) may be present even though rash is not evident. If such signs and symptoms are present, the patient should be evaluated immediately and Lamictal discontinued if an alternative aetiology cannot be established.
Psychiatric Disorders: Common: Aggression, irritability. Very Rare: Tics, hallucinations, confusion.
Nervous System Disorders: Very Common: Headache. Common: Somnolence, insomnia, dizziness, tremor. Uncommon: Ataxia. Rare: Nystagmus.
Eye Disorders: Uncommon: Diplopia, blurred vision.
Gastrointestinal Disorders: Common: Nausea, vomiting, diarrhea.
Hepatobiliary Disorders: Very Rare: Increased liver function tests, hepatic dysfunction, hepatic failure.
Hepatic dysfunction usually occurs in association with hypersensitivity reactions but isolated cases have been reported without overt signs of hypersensitivity.
Musculoskeletal and Connective Tissue Disorders: Very Rare: Lupus-like reactions.
General Disorders and Administration Site Conditions: Common: Tiredness.
Bipolar Disorder: The following adverse reactions were identified during bipolar disorder clinical trials and should be considered alongside those seen in the epilepsy clinical trials and post-marketing sections for an overall safety profile of Lamictal.
Skin and Subcutaneous Tissue Disorders: Very Common: Skin rash. Rare: Stevens-Johnson syndrome.
When all bipolar disorder studies (controlled and uncontrolled) conducted with Lamictal are considered, skin rashes occurred in 12% of patients on Lamictal. Whereas, in controlled clinical trials with bipolar disorder patients, skin rashes occurred in 8% of patients taking Lamictal and in 6% of patients taking placebo.
Nervous System Disorders: Very Common: Headache. Common: Agitation, somnolence, dizziness.
Musculoskeletal and Connective Tissue Disorders: Common: Arthralgia.
General Disorders and Administration Site Conditions: Common: Pain, back pain.
Post-marketing: This section includes adverse reactions identified through post-marketing surveillance for both indications. These adverse reactions should be considered alongside those seen in the epilepsy and bipolar disorder clinical trials sections for an overall safety profile of Lamictal.
Blood and Lymphatic System Disorders: Very rare: Haemophagocytic lymphohistiocytosis (see Precautions).
Immune System Disorders: Very rare: Hypogammaglobulinaemia.
Skin and Subcutaneous Tissue Disorders: Rare: Alopecia.
Psychiatric Disorders: Very rare: Nightmares.
Nervous System Disorders: Very common: Somnolence, ataxia, headache, dizziness. Common: Nystagmus, tremor, insomnia. Rare: Aseptic meningitis (see Precautions). Very rare: Agitation, unsteadiness, movement disorders, worsening of Parkinson's disease, extrapyramidal effects, choreoathetosis.
There have been reports that Lamictal may worsen parkinsonian symptoms in patients with preexisting Parkinson’s disease, and isolated reports of extrapyramidal effects and choreoathetosis in patients without this underlying condition.
Eye Disorders: Very common: Diplopia, blurred vision. Rare: Conjunctivitis.
Gastrointestinal Disorders: Very common: Nausea, vomiting. Common: Diarrhoea.
Renal and Urinary Disorders: Very rare: Tubulointerstitial nephritis*.
*May occur in association with uveitis.
Epilepsy only: Nervous System Disorders: Very rare: Increase in seizure frequency.