Lamotrix 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 as follows. All three sections should be consulted when considering the overall safety profile of LAMOTRIX.
The following convention has been used utilised for the classification of undesirable effects: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1000 to < 1/100), Rare (≥ 1/10,000 to < 1/1000), 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 lamotrigine.
Skin and subcutaneous tissue disorders: Very common: Skin rash; Rare: Stevens Johnson syndrome; Very rare: Toxic epidermal necrolysis.
In a double-blind, add-on clinical trials in adults, skin rashes occurred in up to 10% of patients taking lamotrigine and in 5% of patients taking placebo. The skin rashes led to the withdrawal of lamotrigine treatment in 2% of patients. The rash, usually maculopapular in appearance, generally appears within eight weeks of starting treatment and resolves on withdrawal of lamotrigine (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 recovers 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 lamotrigine and exceeding the recommended dose escalation of lamotrigine therapy (see Dosage & Administration); concomitant use with valproate (see Dosage & Administration). Rash has also been reported as part of a hypersensitivity syndrome associated with a variable pattern of systemic symptoms (see Immune system disorders**).
Blood and lymphatic system disorders: Very rare: Haematological abnormalities including neutropenia, leucopenia, anemia, thrombocytopenia, pancytopenia, aplastic anaemia and agranulocytosis. Frequency not known: Lymphadenopathy; Haematological abnormalities may or may not be associated with the hypersensitivity syndrome (see Immune system disorders**).
Immune system disorders: Very rare: Hypersensitivity syndrome** (including such symptoms as fever, lymphadenopathy, facial oedema, abnormalities of the blood and liver, disseminated intravascular coagulation (DIC), multi-organ failure.
** Rash has also been reported as part of a hypersensitivity syndrome associated with a variable pattern of systemic symptoms including fever, lymphadenopathy, facial oedema, abnormalities of the blood and liver. The syndrome 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 or symptoms are present, the patient should be evaluated immediately and LAMOTRIX discontinued if an alternative aetiology cannot be established.
Psychiatric disorders: Common: Aggression, Irritability; Very rarely: 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, diarrhoea.
Hepato-billiary 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.
Musculo-skeletal 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 epilepsy clinical trials and post-marketing sections for an overall safety profile of lamotrigine.
Skin and subcutaneous tissue disorders: Very common: Skin rash; Rare: Stevens Johnson syndrome; When all bipolar disorder studies (controlled and uncontrolled) conducted with lamotrigine are considered, skin rashes occurred in 12% of patients on lamotrigine. Whereas, in controlled clinical trials with bipolar disorder patients, skin rashes occurred in 8% of patients taking lamotrigine and in 6% of patients taking placebo.
Nervous system disorders: Very common: Headache; Common: Agitation, somnolence, dizziness.
Musculo-skeletal and connective tissue disorders: Common: Arthralgia.
General disorders and administration site conditions: Common: Pain, backpain.
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 lamotrigine.
Blood and lymphatic system disorders: Very rare: Haemophagocytic lymphohistiocytosis (see Precautions).
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 lamotrigine may worsen parkinsonian symptoms in patients with pre-existing 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.
Epilepsy only: Nervous system disorders: Very rare: Increase in seizure frequency.