pharmacopeia
GET
/api/v1/drug/diclofenac
2D structure
2-[2-(2,6-dichloroanilino)phenyl]acetic acid
SMILES C1=CC=C(C(=C1)CC(=O)O)NC2=C(C=CC=C2Cl)Cl
InChIKey DCOPUUMXTXDBNB-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Cyclooxygenase Inhibitors.

Cyclooxygenase

Indications

Sourced from openFDA
  • Uses for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.

Dosage & administration

Sourced from openFDA

Directions Use up to 21 days unless directed by your doctor Not for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries. Daily Per Dose For your arthritis pain: Use 4 times per day every day Do not use on more than 2 body areas at the same time Use ENCLOSED DOSING CARD to measure a dose For each upper body area (hand, wrist, or elbow) – Squeeze out 2.25 inches (2 grams) For each lower body area (foot, ankle or knee) –Squeeze out 4.5 inches (4 grams) Read the enclosed User Guide for complete instructions: use only as directed do not use more than directed or for longer than directed apply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes do not apply in same area as any other product do not apply with external heat such as heating pad do not apply a bandage over the treated area store ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1% product. The dosing card is re-usable.

Warnings & precautions

Sourced from openFDA

For external use only Allergy alert: Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives asthma (wheezing) skin reddening blisters facial swelling shock rash If an allergic reaction occurs, stop use and seek medical help right away. Liver warning: This product contains diclofenac. Liver damage may occur if you apply more or for a longer time than directed when using other drugs containing diclofenac Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is small but higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product apply more or for longer than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use if you have ever had an allergic reaction to any other pain reliever or to a fever reducer for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.

Approval history

Sourced from openFDA
  • Mar 26, 1996ANDAANDA074514Actavis Elizabeth
  • Dec 24, 1997NDANDA020607Pfizer
  • Aug 6, 1998ANDAANDA075219Teva
  • Jan 31, 2007NDANDA021234Ibsa
  • Oct 17, 2007NDANDA022122Haleon Us Holdings
  • Jun 16, 2009NDANDA022202Assertio Speclty
  • Jun 17, 2009NDANDA022165Assertio Speclty
  • Dec 19, 2018NDANDA206976Ibsa Inst Bio

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
162,483 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective31,97020%
  2. 2Pain16,0259.9%
  3. 3Fatigue14,0508.6%
  4. 4Off Label Use13,7608.5%
  5. 5Product Use In Unapproved Indication13,4768.3%
  6. 6Arthralgia11,4157.0%
  7. 7Rash10,9766.8%
  8. 8Rheumatoid Arthritis10,7646.6%
  9. 9Nausea9,8246.0%
  10. 10Abdominal Discomfort9,7346.0%
  11. 11Product Use Issue9,4385.8%
  12. 12Joint Swelling9,0325.6%
  13. 13Headache8,9785.5%
  14. 14Alopecia8,7755.4%
  15. 15Systemic Lupus Erythematosus8,1815.0%

Literature

View JSON

Recent PubMed references pinned to Diclofenac as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 584 ClinicalTrials.gov registrations naming Diclofenac as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Diclofenac. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

Frequently asked questions

How does Diclofenac work?
Mechanism-of-action class: Cyclooxygenase Inhibitors.
What is Diclofenac used for?
According to FDA labeling, Diclofenac carries indications including: Uses for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Diclofenac?
Diclofenac is classified as Acetic acid derivatives and related substances, Antiinflammatory agents, non-steroids, Antiinflammatory preparations, non-steroids for topical use, Other dermatologicals, Nonsteroidal Anti-inflammatory Drug, Cyclooxygenase Inhibitors, Decreased Prostaglandin Production.
What are the brand names for Diclofenac?
Diclofenac is marketed under brand names including Aleve Arthritis Pain, Arthrotec, Cambia, Cataflam, Flector, Licart, Lofena, Pennsaid.
Note. Data for diclofenac is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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