Imodium 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 HCl based on the comprehensive assessment of the available adverse event information. A causal relationship with Loperamide HCl 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: Adults and Pediatrics 12 Years and Over: Acute Diarrhea: The safety of Loperamide HCl was evaluated in 2755 patients aged ≥12 years who participated in 26 controlled and uncontrolled clinical trials of Loperamide HCl used for the treatment of acute diarrhea. Adverse reactions reported for ≥1% of Loperamide HCl-treated patients are shown in Table 1. (See Table 1.)

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Adverse reactions reported by <1% of Loperamide HCl-treated patients (N=2755) in the mentioned clinical trial dataset are shown in Table 2. (See Table 2.)

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Chronic Diarrhea: The safety of Loperamide HCl was evaluated in 321 patients who participated in 5 controlled and uncontrolled clinical trials of Loperamide HCl used for the treatment of chronic diarrhea. Treatment periods ranged from 1 week to 52 months. (See Table 3.)

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Adverse reactions reported by <1% of loperamide HCl-treated patients (N=321) in the mentioned clinical trial dataset are shown in Table 4. (See Table 4.)

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Paediatrics Under 12 Years: Acute Diarrhea: The safety of Loperamide HCl was evaluated in 607 patients aged less than 12 years who participated in 13 controlled and uncontrolled clinical trials of Loperamide HCl used for the treatment of acute diarrhea. Adverse reactions reported for ≥1% of Loperamide HCl treated patients are shown in Table 5. (See Table 5.)

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Adverse reactions reported by <1% of Loperamide HCl-treated patients <12 years (N=607) in the mentioned clinical trial dataset are shown in Table 6. (See Table 6.)

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Post marketing Experience: Adverse reactions first identified during post-marketing experience with Loperamide HCl are included in Table 7. In each table, the frequencies are provided according to the following convention: Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1000 and <1/100; Rare ≥1/10000 and <1/1000; Very rare <1/10000 including isolated reports; Not known: Cannot be estimated from the available data.
In Table 7, ADRs are presented by frequency category based on spontaneous reporting rates. (See Table 7.)

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