Reminyl 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 galantamine hydrobromide based on the comprehensive assessment of the available adverse event information. A causal relationship with galantamine hydrobromide 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: Double-blind data - adverse drug reactions reported at ≥1% frequency: The safety of REMINYL was evaluated in 6502 subjects with mild to moderately severe dementia of the Alzheimer's type who participated in 8 placebo-controlled, double-blind clinical trials. The information presented in this section was derived from pooled data.
Adverse reactions reported by ≥1% of REMINYL-treated subjects in these trials are shown in Table 1. (See Table 1.)

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In a randomized, double-blind, placebo-controlled clinical trial, the safety profile of once-daily treatment with REMINYL prolonged release capsules was similar in frequency and nature to that seen with tablets.
Nausea and vomiting, the most frequent adverse reactions, occurred mainly during titration periods, lasted less than a week in most cases and the majority of patients had one episode. Prescription of anti-emetics and ensuring adequate fluid intake may be useful in these instances.
Double blind and open-label data - adverse drug reactions reported at <1% frequency: In addition to double-blind clinical trials, the safety of REMINYL was evaluated in 1454 subjects with mild to moderately severe dementia of the Alzheimer's type who participated in 5 open-label clinical trials.
Additional adverse reactions not reported in Table 1 that occurred in <1% of REMINYL-treated subjects (n=5410) in the 8 double-blind and 5 open-label clinical datasets are listed in Table 2. (See Table 2.)

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Postmarketing Data: In addition to the adverse reactions reported during clinical studies and listed previously, the following adverse reactions have been reported during postmarketing experience. Table 3 provides adverse reaction frequencies 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 (<0.01%), including isolated reports. Not known: Cannot be estimated from the available data. (See Table 3.)

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