Ibuprofen with or without an antiemetic for acute migraine headaches in adults



This is an updated version of the original review published in Issue 10, 2010 (Rabbie 2010). Migraine is a common, disabling condition and a burden for the individual, health services and society. Many sufferers do not seek professional help, relying instead on over‐the‐counter analgesics. Co‐therapy with an antiemetic should help to reduce symptoms commonly associated with migraine headaches.


To determine efficacy and tolerability of ibuprofen, alone or in combination with an antiemetic, compared to placebo and other active interventions in the treatment of acute migraine headaches in adults.

Search methods

We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Oxford Pain Relief Database, ClinicalTrials.gov, and reference lists for studies through 22 April 2010 for the original review and to 14 February 2013 for the update.

Selection criteria

We included randomised, double‐blind, placebo‐ or active‐controlled studies using self‐administered ibuprofen to treat a migraine headache episode, with at least 10 participants per treatment arm.

Data collection and analysis

Two review authors independently assessed trial quality and extracted data. Numbers of participants achieving each outcome were used to calculate relative risk and number needed to treat (NNT) or harm (NNH) compared to placebo or other active treatment.

Main results

No new studies were found for this update. Nine included studies (4373 participants, 5223 attacks) compared ibuprofen with placebo or other active comparators; none combined ibuprofen with a self‐administered antiemetic. All studies treated attacks with single doses of medication. For ibuprofen 400 mg versus placebo, NNTs for 2‐hour pain‐free (26% versus 12% with placebo), 2‐hour headache relief (57% versus 25%) and 24‐hour sustained headache relief (45% versus 19%) were 7.2, 3.2 and 4.0, respectively. For ibuprofen 200 mg versus placebo, NNTs for 2‐hour pain‐free (20% versus 10%) and 2‐hour headache relief (52% versus 37%) were 9.7 and 6.3, respectively. The higher dose was significantly better than the lower dose for 2‐hour headache relief. Soluble formulations of ibuprofen 400 mg were better than standard tablets for 1‐hour, but not 2‐hour headache relief.

Similar numbers of participants experienced adverse events, which were mostly mild and transient, with ibuprofen and placebo.

Ibuprofen 400 mg did not differ from rofecoxib 25 mg for 2‐hour headache relief or 24‐hour headache relief.

Authors' conclusions

We found no new studies since the last version of this review. Ibuprofen is an effective treatment for acute migraine headaches, providing pain relief in about half of sufferers, but complete relief from pain and associated symptoms for only a minority. NNTs for all efficacy outcomes were better with 400 mg than 200 mg in comparisons with placebo, and soluble formulations provided more rapid relief. Adverse events were mostly mild and transient, occurring at the same rate as with placebo.


Roy Rabbie, Sheena Derry, R Andrew Moore


Plain language summary

Ibuprofen with or without an antiemetic for acute migraine headaches in adults

This is an updated version of the original Cochrane review published in Issue 10, 2010 (Rabbie 2010); no new studies were found. A single oral dose of ibuprofen 200 mg or 400 mg is effective in relieving pain in migraine headaches. Pain will be reduced from moderate or severe to no pain by two hours in just over 1 in 4 people (26%) taking ibuprofen 400 mg, compared with about 1 in 10 (12%) taking placebo. It will be reduced from moderate or severe to no worse than mild pain by two hours in roughly 1 in 2 people (57%) taking ibuprofen compared with approximately 1 in 4 (25%) taking placebo. Of those who experience effective headache relief at two hours, more have that relief sustained over 24 hours with ibuprofen than with placebo. A 200‐mg dose is slightly less effective, while soluble formulations give more rapid responses. A single 400‐mg dose of ibuprofen has efficacy similar to that shown for a single dose of 1000 mg aspirin in a separate Cochrane review (Kirthi 2013).

Adverse events are mostly mild and transient, occurring in the same proportion of participants treated with ibuprofen and placebo. Very few individuals had serious adverse events or needed to withdraw from these studies because of adverse events.

There is no information for ibuprofen combined with a self‐administered antiemetic, and little information comparing ibuprofen with other medications. There were no significant differences between ibuprofen 400 mg and rofecoxib 25 mg (now withdrawn) for 2‐hour headache relief, 24‐hour sustained headache relief, or use of rescue medication.


Roy Rabbie, Sheena Derry, R Andrew Moore

Reviewer's Conclusions

Authors' conclusions 

Implications for practice 

Ibuprofen is an effective treatment for acute migraine headaches in adults at doses of 200 mg and 400 mg, providing complete headache relief within two hours to 1 in 5 and 1 in 4 individuals taking those doses, respectively; participants in these studies also experienced reduction in pain (about 1 in 2), functional disability and migraine‐associated symptoms, such as nausea and photophobia. The 400 mg dose was numerically superior to 200 mg for all efficacy outcomes, but achieved statistical significance only for headache relief at two hours. Soluble formulations gave significantly better results for headache relief than standard tablets at one, but not two hours. No increase in numbers of participants with any adverse event, adverse event withdrawals or serious adverse events was seen with ibuprofen compared to placebo. Ibuprofen 400 mg would seem to be a good first‐line therapy for acute migraine headaches in this population.

Implications for research 

Further studies are needed to establish the efficacy of the more soluble formulations of ibuprofen, particularly ibuprofen lysine, and of higher doses (600 to 800 mg). Direct comparisons with triptans and other OTC analgesics, such as aspirin and paracetamol would help to clarify the relative efficacy of the various treatment options. Ideally these studies would be head‐to‐head comparisons and would include a placebo comparator for internal validity. Combining ibuprofen with an antiemetic, such as metoclopramide, has the potential to provide better relief of nausea and vomiting, and may also improve headache relief.

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