Layer 1

Presenting the GI evidence of ibuprofen

Brought to you by

Presenting the GI evidence of ibuprofen

Evidence that OTC ibuprofen is as well tolerated as paracetamol on the GI tract

A survey revealed that 65% of UK pharmacists believe that paracetamol has a better safety profile than ibuprofen at OTC doses.1

Concerns about OTC ibuprofen could come from some of the guidance seen for prescription doses of the drug, and an assumption that the same applies at OTC levels, but is this caution supported by the evidence?

OTC ibuprofen is as well tolerated as paracetamol on the GI tract*2

Figure 1. Adapted from Moore et al. 19992

There are some special warnings and contraindications regarding GI safety of ibuprofen (including those with pre-existing GI conditions – please see SPCs for full details).

*Based on the evaluable patient number.

At OTC doses, the incidence of GI AEs in both adults and children receiving ibuprofen has been shown to be similar to that of paracetamol.2,3

OTC dose ibuprofen has a lower risk of GI events than prescription dose ibuprofen4

Figure 2. Adapted from Lanza et al. 19844

What is the safety profile of ibuprofen?

You can inform patients by explaining some of the facts around ibuprofen safety:

FACT: A large-scale clinical trial showed that reported GI adverse events (AEs) are very similar between OTC ibuprofen and paracetamol.2 (see figure 1)

FACT: Ibuprofen has a low GI risk compared with other non-steroid anti-inflammatory drugs (NSAIDs).5,6

FACT: An endoscopy study showed that the degree of mucosal damage seen with ibuprofen is generally dose-dependent, with little or no mucosal injury seen with 1200mg/day.3

FACT: There is no evidence that food has a gastroprotective benefit when taking OTC ibuprofen.7 Food may delay NSAID absorption.7,8 In suitable patients, it may be more appropriate to take NSAIDs when fasting.7-9

Additionally ibuprofen provides faster and more effective headache relief than paracetamol (ref. 10)

A double-blind, randomised, parallel group study evaluated 154 patients taking a single dose of solubilised ibuprofen (400mg), paracetamol (1000mg) or placebo for the relief of episodic tension type headache10 (see figure 3)

  • Patients provided stopwatches and asked to stop them once they had received meaningful relief (patient defined)10
  • Pain intensity and relief were also measured using traditional categorical four and five-point scales, respectively at 2 and 3 hours postdosing.10
Percentage of subjects obtaining meaningful relief by 30 minutes and complete relief by three hours10

Figure 3. Adapted from Packman et al. 200010

Ibuprofen liquid capsules (400mg) provide significantly faster relief than paracetamol tablets (1000mg) in patients with tension-type headache10

To explore the evidence on ibuprofen safety and efficacy in more detail, please visit


  1. McCaul F, et al. SelfCare 2019;10(3):79-92.
  2. Moore N, et al. Clin Drug Invest 1999;18:89–98.
  3. Bjarnason I. J R Soc Med 2007;100 Suppl 48:11–14.
  4. Lanza FL. Am J Med, 1984;77:19–24.
  5. Hersh EV, Moore PA, Ross GL. Over-the-counter analgesics and antipyretics: a critical assessment. Clin Ther 2000;22(5):500–548.
  6. Henry D, Drew A, Beuzeville S. Chapter 8: Gastrointestinal adverse drug reactions attributed to ibuprofen. In: Rainsford KD (ed). Ibuprofen: A Critical Bibliographic Review. 1999. CRC Press, Taylor and Francis, London.
  7. Rainsford KD, Bjarnason I. J Pharm Pharmacol, 2012;64: 465–9.
  8. Geisslinger G, et al. Int J Clin Pharmacol Ther Toxicol, 1989;27:324–8.
  9. Moore RA, et al. Cochrane Database of Systematic Reviews 2015, Issue 11. Art. No.: CD010794. DOI: 10.1002/14651858.CD010794.pub2.
  10. Packman BP, et al. Headache, 2000;40:561-567.

Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to Reckitt Benckiser Healthcare (UK) ltd on: 0333 200 5345


Essential information

Click here to download a pdf with more information to share with your team.


Date of preparation: September 2020