Sinutab Cold/Sinutab Cold Plus Adverse Reactions

Sinutab Cold: Clinical Trial Data: Placebo-controlled studies with sufficient adverse event data were not available for the combination of paracetamol and phenylephrine.
The following adverse events were reported by ≥1% of subjects in randomized, placebo-controlled trials with single-ingredient phenylephrine were nausea, nasal dryness and headache.
Post Marketing Data: Adverse drug reactions (ADRs) identified during post-marketing experience with paracetamol, phenylephrine are included in Table 3. 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 and <1/1,000; Very rare <1/10,000; Not known (cannot be estimated from the available data).
In Table 3, the ADRs are presented with ADR frequency categories estimated from spontaneous reporting rates where numerator represents total number of reported Company adverse events (AEs) under given a preferred term (PT) or medical concept and denominator represents exposure data calculated from sales data. (See Table 3.)

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Sinutab Cold Plus: Clinical Trial Data: Placebo-controlled studies with sufficient adverse event data were not available for the combination of chlorpheniramine, paracetamol and phenylephrine.
The following adverse events were reported by ≥1% of subjects in randomized, placebo-controlled trials with single-ingredient chlorpheniramine and phenylephrine: dizziness, somnolence, dry mouth, dyspepsia, pharyngitis, feeling jittery, headache, nausea and nasal dryness. The adverse events related to chlorpheniramine were dizziness, somnolence, dry mouth, dyspepsia, pharyngitis and feeling jittery. The adverse events related to phenylephrine were headache, nausea, and nasal dryness.
Post Marketing Data: Adverse drug reactions (ADRs) identified during post-marketing experience with chlorpheniramine, paracetamol, phenylephrine are included in Table 2 and 4. In these tables, 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 and <1/1,000; Very rare <1/10,000; Not known (cannot be estimated from the available data).
In Table 4, the ADRs are presented with ADR frequency categories estimated from spontaneous reporting rates where numerator represents total number of reported Company AEs under given preferred term (PT) or medical concept and denominator represents exposure data calculated from sales data. (See Table 4.)

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