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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 Product label issue? 34 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 34 reports of Product label issue have been filed in association with DICLOFENAC (Diclofenac Sodium Delayed Release). This represents 0.0% of all adverse event reports for DICLOFENAC.

34
Reports of Product label issue with DICLOFENAC
0.0%
of all DICLOFENAC reports
10
Deaths
9
Hospitalizations

How Dangerous Is Product label issue From DICLOFENAC?

Of the 34 reports, 10 (29.4%) resulted in death, 9 (26.5%) required hospitalization, and 10 (29.4%) were considered life-threatening.

Is Product label issue Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for DICLOFENAC. However, 34 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 Product label issue?

RIVAROXABAN (379) ACETAMINOPHEN (276) GUSELKUMAB (177) USTEKINUMAB (164) DIMETHICONE\LOPERAMIDE (154) CETIRIZINE (138) IBUPROFEN (99) GOLIMUMAB (76) POLYETHYLENE GLYCOL 3350 (76) FENTANYL (72)

Which DICLOFENAC Alternatives Have Lower Product label issue 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 Product label issue Reports All Drugs Causing Product label issue DICLOFENAC Demographics