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Table 3 Incidence of adverse events in the safety population (i.e. all subjects who dosed at least once with any study medication) in the four randomized, controlled studies (reproduced with permission from Migliardi et al.)[10]

From: Use of a fixed combination of acetylsalicylic acid, acetaminophen and caffeine compared with acetaminophen alone in episodic tension-type headache: meta-analysis of four randomized, double-blind, placebo-controlled, crossover studies

Adverse event Number of patients, n (%)
AAC (n = 1400) APAP (n = 1400) Placebo (n = 702)
Any adverse event 241 (17) 136 (10) 61 (9)
Stomach upset 130 (9) 67 (5) 34 (5)
Nervousness 61 (4) 13 (1) 4 (1)
Dizziness 58 (4) 22 (2) 7 (1)
  1. AAC = acetylsalicylic acid, acetaminophen, caffeine; APAP = acetaminophen.