Lamoga-50/Lamoga-100 Adverse Reactions

Following are the adverse reactions identified from Epilepsy and Bipolar disorders: Epilepsy: Skin and subcutaneous tissue disorders: Very common: Skin rash. Rare: Stevens Johnson syndrome. Very rare: Toxic epidermal necrolysis.
The overall risk of rash appears to be strongly associated with: High doses of Lamotrigine and exceeding the recommended dose escalation of Lamotrigine therapy (See Dosage & Administration).
Concomitant use of Valproate (see Dosage & Administration).
Blood and lymphatic system disorders: Very rare: Hematological abnormalities (including, neutropenia, leucopenia, anemia, thrombocytopenia, pancytopenia, aplastic anemia, agranulocytosis), lymphadenopathy.
Hematological abnormalities and lymphadenopathy may or may not be associated with DRESS/ Hypersensitivity Syndrome (see Warnings and precautions and Immune System Disorders**).
Immune system disorders: Very rare: DRESS/Hypersensitivity syndrome** including such symptoms as, fever, lymphadenopathy, facial edema, 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 multi-organ 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 Lamotrigine discontinued if an alternative etiology 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: Very rare: Tiredness.
Bipolar Disorder: Skin and subcutaneous tissue disorders: Very common: Skin rash. Rare: Stevens Johnson syndrome.
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: Blood and Lymphatic system disorder: Very rare: Hemaphagocytic lymphohistiocytosis (see Warnings and Precautions).