Registration Dossier
Registration Dossier
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EC number: 206-144-2 | CAS number: 303-49-1
Endpoint summary
Administrative data
Description of key information
STOT SE 1 H370
In humans, clomipramine induces central nervous system (CNS) and cardiovascular effects at therapeutic (0.5-2 mg/kg) and supratherapeutic doses. CNS effects are not limited to dizziness and vertigo, and include hallucinations due to the anticholinergic properties of the substance as well as seizures. Cardiovascular effects include tachycardia, QRS widening and hypotension.
[Antidepressants, tricyclic - Poisindex(R) Management]
STOT SE 3 H336
In controlled trials, somnolence, dizziness, or tremor was each reported in about 54% of adults and in about 46, 41, or 33%, respectively, of children and adolescents receiving clomipramine. Headache occurred in about 52% of adults and 28% of children and adolescents receiving clomipramine. Fatigue occurred in about 39% of adults and 35% of children and adolescents receiving the drug. Insomnia occurred in about 25% of adults and 11% of children and adolescents and nervousness occurred in about 18% of adults and 4% of children and adolescents treated with clomipramine.
Dizziness
a) Incidence: 41% to 54% (Prod Info ANAFRANIL(R) oral capsules, 2007a)
b) Adults: in placebo-controlled clinical trials of adult patients with obsessive compulsive disorder (OCD), the incidence of dizziness was 54% with clomipramine (n=322) compared with 14% with placebo (n=319) (Prod Info ANAFRANIL(R) oral capsules, 2007a).
c) Pediatrics: in placebo-controlled clinical trials of children and adolescents with obsessive compulsive disorder (OCD), the incidence of dizziness was 41% with clomipramine (n=46) compared with 14% with placebo (n=44) (Prod Info ANAFRANIL(R) oral capsules, 2007a).
Somnolence
a) Incidence: 46% to 54% (Prod Info ANAFRANIL(R) oral capsules, 2007a)
b) Adults: in placebo-controlled clinical trials of adult patients with obsessive compulsive disorder (OCD), the incidence of somnolence was 54% with clomipramine (n=322) compared with 16% with placebo (n=319).
Somnolence was the primary reason for discontinuation of treatment(Prod Info ANAFRANIL(R) oral capsules, 2007a).
c) Pediatrics: in placebo-controlled clinical trials of children and adolescents with obsessive compulsive disorder (OCD), the incidence of somnolence was 46% with clomipramine (n=46) compared with 11% with placebo (n=44). Somnolence was the primary reason for discontinuation of treatment(Prod Info ANAFRANIL(R) oral capsules, 2007a).
[DRUGDEX DRUG EVALUATIONS]
Even if the CNS mentioned adverse effects (i.e. dizziness, somnolence and CNS depression) were observed at therapeutic dose, and may have limited importance for industrial chemicals and their safety assessment, the substance is classified as STOT SE 3 H336, since it is not possible to establish if these type of effects are relevant at lower doses.
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