Does CODEINE Cause Off label use? 1,662 Reports in FDA Database

Q: Does CODEINE cause Off label use?

1,662 reports of Off label use have been filed with the FDA for CODEINE, representing 7.6% of all CODEINE adverse event reports.

Q: How dangerous is Off label use from CODEINE?

Of 1,662 reports, 258 (15.5%) resulted in death and 546 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 1,662 reports of Off label use have been filed in association with CODEINE (Codeine-Guaifenesin). This represents 7.6% of all adverse event reports for CODEINE.

1,662

Reports of Off label use with CODEINE

7.6%

of all CODEINE reports

258

Deaths

546

Hospitalizations

How Dangerous Is Off label use From CODEINE?

Of the 1,662 reports, 258 (15.5%) resulted in death, 546 (32.9%) required hospitalization, and 168 (10.1%) were considered life-threatening.

Is Off label use Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for CODEINE. However, 1,662 reports have been filed with the FAERS database.

What Other Side Effects Does CODEINE Cause?

Drug hypersensitivity (7,479) Toxicity to various agents (2,951) Drug ineffective (2,632) Drug abuse (2,122) Pain (2,024) Rash (1,931) Nausea (1,907) Rheumatoid arthritis (1,861) Headache (1,701) Overdose (1,622)

What Other Drugs Cause Off label use?

RITUXIMAB (39,751) INFLIXIMAB (34,801) DENOSUMAB (34,612) METHOTREXATE (24,020) VEDOLIZUMAB (21,017) ETANERCEPT (20,178) TOCILIZUMAB (18,256) PREDNISONE (17,867) LENALIDOMIDE (17,017) ADALIMUMAB (16,417)

Which CODEINE Alternatives Have Lower Off label use Risk?

CODEINE vs CODEINE\GUAIFENESIN CODEINE vs CODEINE\IBUPROFEN CODEINE vs CODEINE\PROMETHAZINE CODEINE vs COLCHICINE CODEINE vs COLCHICINE\DICYCLOMINE

CODEINE Full Profile All Off label use Reports All Drugs Causing Off label use CODEINE Demographics