Oral tolfenamic acid for acute migraine

Clinical bottom line:

Oral tolfenamic acid has been tested in only a single small trial in acute migraine, involving about 80 patients. It is unsafe to draw any conclusions.

This information comes from an as-yet unpublished systematic review. The only outcome reported here is that of headache response at two hours, though other outcomes may be available in the full paper.

Inclusion criteria were: treatment of acute migraine; randomised allocation to treatment groups; double-blind design; adult population and headache outcomes.


Comprehensive searches of the following databases were made: MEDLINE (1966 - July 2000), EMBASE (1980 - June 2000), Cochrane Library (Issue 3, 2000) and the Oxford Pain Relief Database (1950 - 1994). A series of free text searches were undertaken, using generic and trade names. There was no restriction to language. Retrieved reports were searched for additional trials. Neither individual authors nor pharmaceutical companies were contacted for unpublished data.


Tables with all included trials and excluded trials are available.

For oral tolfenamic acid rapid release (200 mg plus a further 200 mg at 60 minutes if headache not improved), 33/43 patients had a headache response at two hours compared with 12/41 with placebo.

Adverse effects

Adverse effects are not reported in any way that makes obvious sense.