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Equetro (Carbamazepine) - Side Effects and Adverse Reactions



The following adverse reactions are discussed in more detail in other sections of the labeling:

  • Serious dermatologic reactions: Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome [see Warnings and Precautions
  • Aplastic anemia/agranulocytosis [see Warnings and Precautions]
  • Drug reaction with eosinophilia and systemic symptoms/multiorgan hypersensitivity [see Warnings and Precautions ]
  • Suicidal Behavior and Ideation [see Warnings and Precautions]
  • Embryofetal Toxicity [see Warnings and Precautions ]
  • Abrupt Discontinuation and Seizure Risk [see Warnings and Precautions]
  • Hyponatremia [see Warnings and Precautions ]
  • Cognitive and Motor Impairment [see Warnings and Precautions]
  • Drug Interaction with Non-Nucleoside Reverse Transcriptase Inhibitors [see Warnings and Precautions ]
  • Hepatic Porphyria [see Warnings and Precautions]
  • Anticholinergic Reactions and Increased Intraocular Pressure [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 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, rash, blurred vision, and speech disorder [see Clinical Studies]. The EQUETRO doses used were 400 to 1600 mg per day.

Table 2. Common Adverse Reactions Reported in Bipolar Disorder Studies 1 and 2 (Incidence ≥ 2% and greater than placebo)
Adverse Reactions EQUETRO®
(N = 251)
(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%

Postmarketing Experience

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

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.

Drug label data at the top of this Page last updated: 2012-11-15

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