Clinical Trial Data: The safety of nicotine from clinical trial data is based on data on a meta-analysis of randomized clinical trials (RCTs) for the treatment of smoking cessation. ADRs with patch formulations identified from clinical trials are presented in Table 3. (See Table 3).

Post-Marketing Data: Adverse drug reactions first identified during post-marketing experience with nicotine are presented in Table 4. 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). (See Table 4).
