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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 Congenital anomaly? 159 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 159 reports of Congenital anomaly have been filed in association with DICLOFENAC (Diclofenac Sodium Delayed Release). This represents 0.2% of all adverse event reports for DICLOFENAC.

159
Reports of Congenital anomaly with DICLOFENAC
0.2%
of all DICLOFENAC reports
19
Deaths
5
Hospitalizations

How Dangerous Is Congenital anomaly From DICLOFENAC?

Of the 159 reports, 19 (11.9%) resulted in death, 5 (3.1%) required hospitalization, and 4 (2.5%) were considered life-threatening.

Is Congenital anomaly Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for DICLOFENAC. However, 159 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 Congenital anomaly?

OXYCODONE (683) ACETAMINOPHEN\OXYCODONE (460) ACETAMINOPHEN\HYDROCODONE (439) TRAMADOL (348) HYDROMORPHONE (341) LEVETIRACETAM (334) ONDANSETRON (334) ABATACEPT (322) BUPRENORPHINE (296) MORPHINE (293)

Which DICLOFENAC Alternatives Have Lower Congenital anomaly 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 Congenital anomaly Reports All Drugs Causing Congenital anomaly DICLOFENAC Demographics