Does ADALIMUMAB-RYVK Cause Overdose? 5 Reports in FDA Database

Q: Does ADALIMUMAB-RYVK cause Overdose?

5 reports of Overdose have been filed with the FDA for ADALIMUMAB-RYVK, representing 1.1% of all ADALIMUMAB-RYVK adverse event reports.

Q: How dangerous is Overdose from ADALIMUMAB-RYVK?

Of 5 reports, 4 (80.0%) resulted in death and 5 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 5 reports of Overdose have been filed in association with ADALIMUMAB-RYVK (Simlandi). This represents 1.1% of all adverse event reports for ADALIMUMAB-RYVK.

Reports of Overdose with ADALIMUMAB-RYVK

1.1%

of all ADALIMUMAB-RYVK reports

Deaths

Hospitalizations

How Dangerous Is Overdose From ADALIMUMAB-RYVK?

Of the 5 reports, 4 (80.0%) resulted in death, 5 (100.0%) required hospitalization.

Is Overdose Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for ADALIMUMAB-RYVK. However, 5 reports have been filed with the FAERS database.

What Other Side Effects Does ADALIMUMAB-RYVK Cause?

Off label use (70) Product dose omission issue (67) Crohn's disease (65) Inappropriate schedule of product administration (57) Rheumatoid arthritis (47) Death (45) Diarrhoea (43)