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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.