Does DICLOFENAC Cause Oligohydramnios? 109 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 109 reports of Oligohydramnios have been filed in association with DICLOFENAC (Diclofenac Sodium Delayed Release). This represents 0.1% of all adverse event reports for DICLOFENAC.
109
Reports of Oligohydramnios with DICLOFENAC
0.1%
of all DICLOFENAC reports
1
Deaths
21
Hospitalizations
How Dangerous Is Oligohydramnios From DICLOFENAC?
Of the 109 reports, 1 (0.9%) resulted in death, 21 (19.3%) required hospitalization, and 8 (7.3%) were considered life-threatening.
Is Oligohydramnios Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for DICLOFENAC. However, 109 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 Oligohydramnios?
IBUPROFEN (233)
VALSARTAN (228)
ACETAMINOPHEN (189)
INDOMETHACIN (166)
TRASTUZUMAB (106)
LOSARTAN (101)
DOXORUBICIN (68)
FUROSEMIDE (65)
CYCLOPHOSPHAMIDE (62)
HYDROXYPROGESTERONE CAPROATE (57)
Which DICLOFENAC Alternatives Have Lower Oligohydramnios Risk?
DICLOFENAC vs DICLOFENAC DIETHYLAMINE
DICLOFENAC vs DICLOFENAC EPOLAMINE
DICLOFENAC vs DICLOFENAC\DICLOFENAC
DICLOFENAC vs DICLOFENAC\MISOPROSTOL
DICLOFENAC vs DICLOXACILLIN