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)
|
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%
|
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.
|