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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

Does DICLOFENAC Cause Lupus-like syndrome? 565 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 565 reports of Lupus-like syndrome have been filed in association with DICLOFENAC (Diclofenac Sodium Delayed Release). This represents 0.7% of all adverse event reports for DICLOFENAC.

565
Reports of Lupus-like syndrome with DICLOFENAC
0.7%
of all DICLOFENAC reports
499
Deaths
393
Hospitalizations

How Dangerous Is Lupus-like syndrome From DICLOFENAC?

Of the 565 reports, 499 (88.3%) resulted in death, 393 (69.6%) required hospitalization, and 379 (67.1%) were considered life-threatening.

Is Lupus-like syndrome Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for DICLOFENAC. However, 565 reports have been filed with the FAERS database.

What Other Side Effects Does DICLOFENAC Cause?

Drug ineffective (24,885) Product use in unapproved indication (12,197) Off label use (10,370) Pain (9,276) Product use issue (8,009) Fatigue (7,908) Rash (7,852) Rheumatoid arthritis (7,366) Abdominal discomfort (7,257) Product administered at inappropriate site (6,919)

What Other Drugs Cause Lupus-like syndrome?

INFLIXIMAB (2,158) ADALIMUMAB (1,745) METHOTREXATE (775) ETANERCEPT (720) ABATACEPT (644) PREDNISONE (638) TOCILIZUMAB (629) CERTOLIZUMAB PEGOL (593) HYDROXYCHLOROQUINE (593) USTEKINUMAB (587)

Which DICLOFENAC Alternatives Have Lower Lupus-like syndrome Risk?

DICLOFENAC vs DICLOFENAC DIETHYLAMINE DICLOFENAC vs DICLOFENAC EPOLAMINE DICLOFENAC vs DICLOFENAC\DICLOFENAC DICLOFENAC vs DICLOFENAC\MISOPROSTOL DICLOFENAC vs DICLOXACILLIN

Related Pages

DICLOFENAC Full Profile All Lupus-like syndrome Reports All Drugs Causing Lupus-like syndrome DICLOFENAC Demographics