Stugeron Adverse Reactions

Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of cinnarizine based on the comprehensive assessment of the available adverse event information. A causal relationship with cinnarizine cannot be reliably established in individual cases. Further, 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.
Clinical trial data: Placebo-controlled double-blind data - adverse reactions reported at ≥1% incidence: The safety of STUGERON (30 to 225 mg/day) was evaluated in 601 subjects (of which 303 were treated with STUGERON, 298 were given placebo) who participated in 6 placebo-controlled, double-blind clinical trials: 2 in the treatment of peripheral circulatory disorders, 1 in the treatment of cerebral circulatory disorders, 1 in the treatment of vertigo, 1 in the prevention of motion sickness, and 1 in the treatment of both vertigo and cerebral circulatory disorders.
Adverse reactions reported by ≥1% of STUGERON-treated subjects noted in the double-blind clinical trials are shown in Table 1. (See Table 1.)

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Comparator and open-label data - adverse reactions reported at ≥1% incidence: Six comparator trials and 13 open label trials were selected to determine the incidence of adverse reactions. In these 19 studies, 937 subjects were treated with doses ranging from 25 to 450 mg/day STUGERON, in the treatment of peripheral circulatory disorders, cerebral circulatory disorders, and vertigo.
Adverse reactions reported by ≥1% of STUGERON-treated subjects noted in the comparator and open label clinical trials are shown in Table 2. (See Table 2.)

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Placebo, comparator, and open-label data - adverse reactions reported at <1% incidence: Additional adverse reactions that occurred in <1% of STUGERON-treated subjects in the above 2 clinical datasets (25 studies with a total of 1240 subjects treated with doses ranging from 25 to 450 mg/day) are listed as follows in Table 3. (See Table 3.)

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Postmarketing data: Adverse events first identified as adverse reactions during postmarketing experience with cinnarizine are included in Table 4. The postmarketing review was based on review of all cases where there was a use of cinnarizine. In Table 4, adverse reactions are presented by frequency category based on spontaneous reporting rates, with frequencies provided according to the following convention: Very common ≥1/10 (≥10%); Common ≥1/100 and <1/10 (≥1% and <10%); Uncommon ≥1/1000 and <1/100 ( (≥0.1% and <1%); Rare ≥1/10000 and <1/1000 (≥0.01 and <0.1%); Very rare <1/10000 including isolated reports (<0.01%); Not known Cannot be estimated from the available data. (See Table 4.)

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