Imodium Complete Relief 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 loperamide-simethicone or loperamide HCl based on the comprehensive assessment of the available adverse event information. A causal relationship with loperamide-simethicone 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: The safety of loperamide-simethicone was evaluated in 2040 patients who participated in five clinical trials. All trials were in patients with acute diarrhea with gas related discomfort and with a chewable tablet loperamide-simethicone formulation. Four trials compared loperamide-simethicone with loperamide, simethicone and placebo and one trial compared two formulations of loperamide- simethicone with placebo. Adverse reactions reported by ≥1% of loperamide-simethicone treated patients (N=618) are shown in Table 1. (See Table 1.)

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Adverse reactions reported by <1% of loperamide simethicone-treated patients in the previously mentioned clinical trial dataset are shown in Table 2. (See Tables 2 and 3.)

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Postmarketing data: Adverse reactions first identified during post marketing experience with loperamide-simethicone or loperamide HCl are included in Table 4. In the table, the frequencies are provided according to the following convention: Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000, <1/1,000; Very rare <1/10,000, including isolated reports.
In Table 4, adverse reactions are presented by frequency category based on spontaneous reporting rates. (See Table 4.)

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