Diclofenac potassium 12.5mg tablets for mild to moderate pain and fever: a review of its pharmacology, clinical efficacy and safety

Clin Drug Investig. 2007;27(3):163-95. doi: 10.2165/00044011-200727030-00002.


Non-prescription (over-the-counter [OTC]) analgesics are used for the short-term treatment of acute painful conditions of mild to moderate intensity in everyday life. Well documented safety and efficacy, a rapid onset of action and a flexible daily dosing regimen are essential in this context. Film-coated, immediate-release, low-dose diclofenac potassium, developed for OTC use, offers a flexible daily dosing regimen with an initial dose of two tablets (2 x 12.5mg) followed by one or two tablets up to a maximum daily dose of six tablets (75 mg/day). The maximum plasma drug concentration is reached 30 minutes after administration, and the mean terminal half-life is 1-2 hours, allowing a 4- to 6-hour duration of activity, depending on the condition. Thirteen randomised, double-blind trials with both placebo and active controls have demonstrated the efficacy of diclofenac potassium 12.5mg tablets in conditions suitable for treatment with OTC medication, for example, acute lower back pain, headache, acute pain after dental extraction, symptoms of cold and influenza (including fever), and dysmenorrhoea. A single dose of diclofenac potassium 12.5mg is the lowest recommended effective dose. A two-tablet single dose of 25mg is at least as effective as ibuprofen 400mg. A flexible dosing regimen of an initial two tablets followed by one or two tablets up to a total daily dose of 75 mg is as effective as ibuprofen used in comparable fashion up to a total daily dose of 1200 mg. The incidence of adverse events in patients taking single or multiple doses of diclofenac potassium is similar to that of ibuprofen and placebo. In a safety study conducted to compare diclofenac potassium with ibuprofen for up to 3 months in patients with osteoarthritis of the knee, no differences in the pattern of adverse events were noted. There was no evidence of either hepatic injury or cardiovascular safety-related issues at any time during the study. Patients are generally capable of taking diclofenac potassium appropriately. A maximum OTC treatment duration of 5 days for pain and 3 days for fever is recommended.

Publication types

  • Review

MeSH terms

  • Cyclooxygenase Inhibitors / adverse effects
  • Cyclooxygenase Inhibitors / chemistry
  • Cyclooxygenase Inhibitors / therapeutic use
  • Diclofenac / adverse effects
  • Diclofenac / chemistry
  • Diclofenac / therapeutic use*
  • Dose-Response Relationship, Drug
  • Fever / drug therapy*
  • Fever / pathology
  • Humans
  • Molecular Structure
  • Pain / drug therapy*
  • Pain / pathology
  • Severity of Illness Index
  • Tablets
  • Treatment Outcome


  • Cyclooxygenase Inhibitors
  • Tablets
  • Diclofenac