Adverse Events

In controlled trials,
Adverse events with FLECTOR were comparable to placebo*

Common AEs in ≥1% of patients treated for up to 2 weeks

  FLECTOR % (n=572) Placebo patch % (n=564)
Pruritus 5 8
Dermatitis 2 <1
Burning <1 1
Other 4 3
GI disorders 9 6
Nausea 3 2
Dysgeusia 2 <1
Dyspepsia 1 1
Other 3 2
Nervous system disorders 2 3
Headache 1 2
Paresthesia 1 1
Somnolence 1 1
Other§ 1 <1
  • Of the patients treated with FLECTOR who had AEs, the majority had AEs with maximum intensity of "mild" or "moderate"
  • 3% of patients in both the FLECTOR and placebo groups discontinued treatment due to an AE
      The most common AEs leading to discontinuation were application site reactions
*Placebo patch was composed of the same ingredients as FLECTOR except for the active ingredient diclofenac; therefore, AEs in the placebo group may reflect effects of the inactive ingredients.
Includes application site dryness, irritation, erythema, atrophy, discoloration, hyperhidrosis, and vesicles.
Includes gastritis, vomiting, diarrhea, constipation, upper abdominal pain, and dry mouth.
§Includes hypoesthesia, dizziness, and hyperkinesia.
Additionally, treated area may develop edema or abnormal sensation.