Does DICLOFENAC Cause Myositis? 213 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 213 reports of Myositis have been filed in association with DICLOFENAC (Diclofenac Sodium Delayed Release). This represents 0.3% of all adverse event reports for DICLOFENAC.
213
Reports of Myositis with DICLOFENAC
0.3%
of all DICLOFENAC reports
199
Deaths
204
Hospitalizations
How Dangerous Is Myositis From DICLOFENAC?
Of the 213 reports, 199 (93.4%) resulted in death, 204 (95.8%) required hospitalization, and 199 (93.4%) were considered life-threatening.
Is Myositis Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for DICLOFENAC. However, 213 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 Myositis?
NIVOLUMAB (682)
PEMBROLIZUMAB (596)
ATORVASTATIN (448)
METHOTREXATE (418)
PREDNISONE (369)
RITUXIMAB (355)
ADALIMUMAB (344)
IPILIMUMAB (305)
ATEZOLIZUMAB (249)
INFLIXIMAB (249)
Which DICLOFENAC Alternatives Have Lower Myositis Risk?
DICLOFENAC vs DICLOFENAC DIETHYLAMINE
DICLOFENAC vs DICLOFENAC EPOLAMINE
DICLOFENAC vs DICLOFENAC\DICLOFENAC
DICLOFENAC vs DICLOFENAC\MISOPROSTOL
DICLOFENAC vs DICLOXACILLIN