Diclofenac: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Diclofenac. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| Skin and appendages | 86% |
| Application site reaction | 84% |
| Pruritus | 59% |
| Rash | 46% |
| Contact dermatitis | 33% |
| Dry skin | 27% |
| Exfoliation | 24% |
| Body as a whole | 21% |
| Paresthesia | 20% |
| Flu syndrome | 10% |
| Digestive system | 8% |
| Metabolic and nutritional disorders | 8% |
| Respiratory system | 8% |
| Pharyngitis | 8% |
| Headache | 7% |
| Infection | 6% |
| Skin carcinoma | 6% |
| Nervous system | 5% |
| Urogenital system | 5% |
| Accidental injury | 4% |
*Highest percentage across placebo-controlled trial tables summarized in current labeling.
Labeled uses
Diclofenac sodium gel, 3% is indicated for the topical treatment of actinic keratoses (AK). Sun avoidance is indicated during therapy.
Source: FDA labeling via NIH DailyMed (set b162d65d…). Not affiliated with FDA or NIH.
Medical disclaimer: Always consult a qualified healthcare professional about any medication.