Diclofenac Stevens-Johnson Syndrome Lawsuit | 2026 Latest Updates

Diclofenac labels warn of serious skin reactions such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). The diclofenac gel label says these reactions can be fatal and may occur without warning. Diclofenac is an NSAID sold as diclofenac sodium and under brand names including Voltaren, Cataflam and Arthrotec. It comes as a tablet, topical gel or suppository, and people use it to treat pain and arthritis symptoms. No diclofenac SJS or TEN lawsuit, MDL or class action has been filed. Stop taking diclofenac at the first sign of a skin rash or any other sign of hypersensitivity, and call a doctor right away.

Latest Diclofenac Stevens-Johnson Syndrome Lawsuit Updates

May 6, 2022: Study Reviews NSAID Skin Reaction Reports

Frontiers in Pediatrics published a study of reports to the FDA Adverse Event Reporting System on Stevens-Johnson syndrome after NSAIDs [1]. It covered January 2004 to March 2021. The authors counted 1,868 SJS reports with NSAIDs, including 202 with diclofenac. They wrote that the signals show a correlation but cannot prove causation. The system relies on voluntary reports.

What Is Stevens-Johnson Syndrome?

A 2024 Toxicology Reports case report calls Stevens-Johnson syndrome a rare but serious skin reaction [2]. Medicines, infections or autoimmune diseases can cause it. It brings flu-like symptoms and a painful rash that spreads and blisters. Mayo Clinic describes diclofenac as a nonsteroidal anti-inflammatory drug used to treat mild-to-moderate pain and relieve arthritis symptoms [3]. Its label warns that it can cause SJS and TEN.

Who May Be Affected?

People who took diclofenac as a tablet, topical gel or suppository and then developed blistering, peeling skin or mouth sores may be affected. That includes people who had a serious skin reaction to an NSAID before. The diclofenac label says the gel is contraindicated in patients with previous serious skin reactions to NSAIDs [4]. In the 2022 FDA-database study, patients aged 45 to 64 years made up 34.29% of diclofenac SJS reports. Whether you have a claim needs an individual legal review by a lawyer.

Reported Injuries or Damages

The diclofenac sodium topical gel label on DailyMed, revised 3/2023, names exfoliative dermatitis, SJS and TEN as serious skin reactions linked to NSAIDs including diclofenac. They can be fatal. It says these events may occur without warning. Mayo Clinic says serious skin reactions can occur during treatment with oral diclofenac. Its warning signs are blistering, peeling or loosening of the skin, and sores, ulcers or white spots in the mouth or on the lips. In the 2022 study, hospitalization was reported in 58.5% of diclofenac SJS reports. Mortality was 25.00% of those reports. These are voluntary reports, not confirmed outcomes. The 2024 case report described a 50-year-old woman diagnosed with SJS after diclofenac suppositories. Diclofenac was stopped and supportive care was given. The authors said the timing suggests a possible drug-induced reaction and that further investigation is needed.

Evidence to Preserve

Keep these items in a safe place, because they show what you took and what happened afterward:

• Product name, strength and form (tablet, gel or suppository)
• Prescription and pharmacy records with fill dates
• Photographs of the rash or blisters over time
• Medical and hospital records and the diagnosis
• A list of other medicines taken at the same time
• Notes on when symptoms began
• The packaging and any leftover medicine

Do not throw away packaging or leftover medicine. Write down dates now, while you still remember them, so the order of events is clear.

Filing Deadlines

Filing deadlines come from state law. They differ with where you live and when the injury and its diagnosis happened. Some states start the clock at diagnosis, so the date of an SJS or TEN diagnosis can matter. Waiting too long can end a claim, however strong the facts. A lawyer should be asked promptly about your own dates.

Frequently Asked Questions

How Serious Are Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis?

Stevens-Johnson syndrome and toxic epidermal necrolysis are rare but serious. The 2022 study reports an average mortality rate of 1-5% for SJS and 25-35% for TEN. Those figures describe the conditions generally, not diclofenac alone.

How Common Is Stevens-Johnson Syndrome in the United States?

Stevens-Johnson syndrome is uncommon in the United States. The 2024 case report puts the annual incidence at around 3.4-6.1 per million population. That figure covers all causes, not only diclofenac.

Can I File a Diclofenac Stevens-Johnson Syndrome Lawsuit?

Whether you can file a diclofenac Stevens-Johnson syndrome lawsuit depends on your own facts. A claim would be an allegation about warning or product liability. It would not be a regulator or court finding.

What Does the Research Say About Diclofenac and SJS?

The research on diclofenac and SJS is limited to reports and one case. Shao, Yin, Zeng and colleagues analyzed reports through March 2021, and a 2024 case report described one patient. Neither shows that diclofenac caused a given reaction.

How Soon After Taking Diclofenac Can SJS Start?

SJS can start soon after taking diclofenac. In the FDA-database study, the median time to onset of diclofenac-related SJS was 3 days, reported with an interquartile range of 0 to 21. These figures come from voluntary reports.

References

1. https://pmc.ncbi.nlm.nih.gov/articles/PMC9120815/
2. https://pmc.ncbi.nlm.nih.gov/articles/PMC10925921/
3. https://www.mayoclinic.org/drugs-supplements/diclofenac-oral-route/description/drg-20069748
4. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fc0e6a51-bec3-f7ee-e053-6394a90ada9a&audience=consumer