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Table 3 Adverse events recorded in 4-h period after ingestion of investigational drugs (randomized patients dataset; n = 99)

From: Tolerability and efficacy of a combination of paracetamol and caffeine in the treatment of tension-type headache: a randomised, double-blind, double-dummy, cross-over study versus placebo and naproxen sodium

Adverse event

PCF n (%)

NAP n (%)

PLA n (%)

Nervousness

11 (14.5)

8 (12.1)

12 (14.6)

Palpitation

4 (5.3)

2 (3.0)

3 (3.7)

Insomnia

4 (5.3)

3 (4.6)

3 (3.7)

Dizziness

6 (7.9)

4 (4.9)

Abdominal pain

5 (6.6)

4 (6.1)

5 (6.1)

Dyspepsia

6 (7.9)

7 (10.6)

5 (6.1)

Nausea

15 (19.7)

15 (22.7)

21 (25.6)

Vomiting

2 (2.6)

3 (4.6)

2 (2.4)

Drowsiness

11 (14.5)

14 (21.2)

13 (15.9)

Fatigue

12 (15.8)

10 (15.2)

14 (17.1)

  1. PCF paracetamol 1,000 mg + caffeine 130 mg (n = 98), NAP naproxen sodium 550 mg (n = 94), PLA placebo (n = 98)