Carbamazepineside effects

The following serious adverse reactions are discussed in more detail in other sections of the labeling: Serious Dermatologic Reactions: Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome Drug Reaction with Eosinophilia and Systemic Symptoms/Multiorgan Hypersensitivity Suicidal Behavior and Ideation Embryofetal Toxicity Abrupt Discontinuation and Seizure Risk Hyponatremia Cognitive and Motor Impairment Drug Interaction with Non-Nucleoside Reverse Transcriptase Inhibitors Liver Damage AV Heart Block Hepatic Porphyria Increased Intraocular Pressure Most common ( > 5% and 2 times placebo) adverse reactions were dizziness, somnolence, nausea, vomiting, ataxia, constipation, pruritus, dry mouth, asthenia, blurred vision, and speech disorder To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-982-5438 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 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 clinical practice. The most commonly reported adverse reactions ( > 5% in the EQUETRO group and at least twice placebo) in the pooled 3-week placebo-controlled trials in patients with acute mania associated with Bipolar I Disorder (Studies 1 and 2) were dizziness, somnolence, nausea, vomiting, ataxia, constipation, pruritus, dry mouth, asthenia, blurred vision, and speech disorder. The EQUETRO doses used were 400 to 1600 mg per day. (Incidence > 2% and greater than placebo) Adverse Reactions EQUETRO ® (N = 251) Placebo (N = 248) Dizziness 44% 12% Somnolence 32% 13% Nausea 29% 10% Vomiting 18% 3% Ataxia 15% 0.4% Constipation 10% 5% Pruritus 8% 2% Dry Mouth 8% 3% Asthenia 8% 4% Rash 7% 4% Blurred vision 6% 2% Speech Disorder 6% 0.4% Hypertension 3% 0.4% Paresthesia 2% 1% Thinking abnormal 2% 0.4% Tremor 3% 1% Twitching 2% 1% Vertigo 2% 1%

6.2 Postmarketing

Experience The following adverse reactions have been identified during post approval use of EQUETRO. 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.

Nervous System: confusion, diplopia, oculomotor disturbances, nystagmus, speech disturbances, abnormal involuntary movements, tinnitus.

Digestive System: gastric distress, abdominal pain, diarrhea, anorexia.

Laboratory Tests: thyroid function tests (T3, T4)- decreased values Other: lupus erythematosus-like syndrome One case of aseptic meningitis, accompanied by myoclonus and peripheral eosinophilia, has been reported in a patient taking carbamazepine in combination with other medications. The patient was successfully dechallenged, and the meningitis reappeared upon rechallenge with carbamazepine.

6.3 Additional

Adverse Reactions Associated with Carbamazepine The following is a list of additional adverse reactions identified in clinical trials or postmarketing reports of other forms of carbamazepine and not reported above for EQUETRO. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Nervous System: Isolated cases of neuroleptic malignant syndrome have been reported in carbamazepine use both with and without concomitant use of other psychotropic drugs.

Skin: onychomadesis, acute generalized exanthematous pustulosis (AGEP). To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-982-5438 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.