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The following serious adverse reactions are described below and elsewhere in the labeling: Hyponatremia [see WARNINGS AND PRECAUTIONS ] Anaphylactic Reactions and Angioedema [see WARNINGS AND PRECAUTIONS ] Cross Hypersensitivity Reaction to Carbamazepine [see WARNINGS AND PRECAUTIONS ] Serious Dermatological Reactions [see WARNINGS AND PRECAUTIONS ] Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS ] Cognitive/Neuropsychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity [see WARNINGS AND PRECAUTIONS ] Hematologic Events [see WARNINGS AND PRECAUTIONS ] Clinical Trials 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most Common Adverse Reactions In All Clinical Studies. Adjunctive Therapy/Monotherapy In Adults Previously Treated With Other AEDs. The most common (?10% more than placebo for adjunctive or low dose for monotherapy) adverse reactions with TRILEPTAL: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, headache, nystagmus tremor, and abnormal gait. Approximately 23% of these 1,537 adult patients discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with discontinuation were: dizziness (6. Monotherapy In Adults Not Previously Treated With Other AEDs. The most common (?5%) adverse reactions with TRILEPTAL in these patients were similar to those in previously treated patients. Approximately 9% of these 295 adult patients discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with discontinuation were: dizziness (1. Adjunctive Therapy/Monotherapy In Pediatric Patients 4 Years Old And Above Previously Treated With Other AEDs. The most common (?5%) adverse reactions with TRILEPTAL in these patients were similar to those seen in adults. Approximately 11% of these 456 pediatric patients discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with discontinuation were: somnolence (2. Monotherapy In Pediatric Patients 4 Years Old And Above Not Previously Treated With Other AEDs. The most common (?5%) adverse reactions with TRILEPTAL in these patients were similar to those in adults. The adverse reactions most commonly associated (?1%) with discontinuation were rash (5. Adjunctive Therapy/Monotherapy In Pediatric Patients 1 Month To Body System/ Adverse Reaction TRILEPTAL Dos age (mg/day) TRILEPTAL 600 N=163 % TRILEPTAL 1200 N=171 % TRILEPTAL 2400 N=126 % Placebo N=166 % Body as a Whole Fatigue 15 12 15 7 Asthenia 6 3 6 5 Leg Edema 2 1 2 1 Increased Weight 1 2 2 1 Feeling Abnormal 0 1 2 0 Cardiovascular System Hypotension 0 1 2 0 Digestive System Nausea 15 25 29 10 Vomiting 13 25 36 5 Abdominal Pain 10 13 11 5 Diarrhea 5 6 7 6 Dyspepsia 5 5 6 2 Constipation 2 2 6 4 Gastritis 2 1 2 1 Metabolic and Nutritional Disorders Hyponatremia 3 1 2 1 Musculoskeletal System Muscle Weakness 1 2 2 0 Sprains and Strains 0 2 2 1 Nervous System Headache 32 28 26 23 Dizziness 26 32 49 13 Somnolence 20 28 36 12 Ataxia 9 17 31 5 Nystagmus 7 20 26 5 Abnormal Gait 5 10 17 1 Insomnia 4 2 3 1 Tremor 3 8 16 5 Nervousness 2 4 2 1 Agitation 1 1 2 1 Abnormal Coordination 1 3 2 1 Abnormal EEG 0 0 2 0 Speech Disorder 1 1 3 0 Confusion 1 1 2 1 Cranial Injury NOS 1 0 2 1 Dysmetria 1 2 3 0 Abnormal Thinking 0 2 4 0 Respiratory System Rhinitis 2 4 5 4 Skin and Appendages Acne 1 2 2 0 Special Senses Diplopia 14 30 40 5 Vertigo 6 12 15 2 Abnormal Vision 6 14 13 4 Abnormal Accommodation 0 0 2 0. Table 4: Adverse Reactions in Controlled Clinical Studies of Monotherapy with TRILEPTAL in Adults Previously Treated with Other AEDs Body System/Adverse Reaction TRILEPTAL 2400 mg/day N=86 % TRILEPTAL 300 mg/day N=86 % Body as a Whole Fatigue 21 5 Fever 3 0 Allergy 2 0 Generalized Edema 2 1 Chest Pain 2 0 Digestive System Nausea 22 7 Vomiting 15 5 Diarrhea 7 5 Dyspepsia 6 1 Anorexia 5 3 Abdominal Pain 5 3 Dry Mouth 3 0 Hemorrhage Rectum 2 0 Toothache 2 1 Hemic and Lymphatic System Lymphade no pathy 2 0 Infections and Infestations Viral Infection 7 5 Infection 2 0 Metabolic and Nutritional Disorders Hyponatremia 5 0 Thirst 2 0 Nervous System Headache 31 15 Dizziness 28 8 Somnolence 19 5 Anxiety 7 5 Ataxia 7 1 Confusion 7 0 Nervousness 7 0 Insomnia 6 3 Tremor 6 3 Amnesia 5 1 Aggravated Convulsions 5 2 Emotional Lability 3 2 Hypoesthesia 3 1 Abnormal Coordination 2 1 Nystagmus 2 0 Speech Disorder 2 0 Respiratory System Upper Respiratory Tract Infection 10 5 Coughing 5 0 Bronchitis 3 0 Pharyngitis 3 0 Skin and Appendages Hot Flushes 2 1 Purpura 2 0 Special Senses Abnormal Vision 14 2 Diplopia 12 1 Taste Perversion 5 0 Vertigo 3 0 Earache 2 1 Ear Infection NOS 2 0 Urogenital and Reproductive System Urinary Tract Infection 5 1 Micturition Frequency 2 1 Vaginitis 2 0. Controlled Clinical Study Of Monotherapy In Adults Not Previously Treated With Other AEDs. Table 5 lists adverse reactions in a controlled clinical study of monotherapy in adults not previously treated with other AEDs that occurred in at least 2% of adult patients with epilepsy treated with TRILEPTAL or placebo and were numerically more common in the patients treated with TRILEPTAL. Table 5: Adverse Reactions in a Controlled Clinical Study of Monotherapy with TRILEPTAL in Adults Not Previously Treated with Other AEDs Body System/ Adverse Reaction TRILEPTAL N=55 % Placebo N=49 % Body as a Whole Falling Down NOS 4 0 Digestive System Nausea 16 12 Diarrhea 7 2 Vomiting 7 6 Constipation 5 0 Dyspepsia 5 4 Musculoskeletal System Back Pain 4 2 Nervous System Dizziness 22 6 Headache 13 10 Ataxia 5 0 Nervousness 5 2 Amnesia 4 2 Abnormal Coordination 4 2 Tremor 4 0 Respiratory System Upper Respiratory Tract Infection 7 0 Epistaxis 4 0 Infection Chest 4 0 Sinusitis 4 2 Skin and Appendages Rash 4 2 Special Senses Vision Abnormal 4 0. Controlled Clinical Studies Of Adjunctive Therapy/Monotherapy In Pediatric Patients Previously Treated With Other AEDs, steroids to order. 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