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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 GUAIFENESIN Cause Off label use? 213 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 213 reports of Off label use have been filed in association with GUAIFENESIN (Guaifenesin and Pseudoephedrine HCl). This represents 2.7% of all adverse event reports for GUAIFENESIN.

213
Reports of Off label use with GUAIFENESIN
2.7%
of all GUAIFENESIN reports
5
Deaths
52
Hospitalizations

How Dangerous Is Off label use From GUAIFENESIN?

Of the 213 reports, 5 (2.3%) resulted in death, 52 (24.4%) required hospitalization, and 2 (0.9%) 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 GUAIFENESIN. However, 213 reports have been filed with the FAERS database.

What Other Side Effects Does GUAIFENESIN Cause?

Drug ineffective (1,583) Incorrect drug administration duration (490) No adverse event (462) Product use in unapproved indication (451) Dizziness (423) Accidental overdose (396) Diarrhoea (359) Nausea (344) Headache (308) Product use issue (290)

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 GUAIFENESIN Alternatives Have Lower Off label use Risk?

GUAIFENESIN vs GUAIFENESIN\HYDROCODONE GUAIFENESIN vs GUAIFENESIN\PSEUDOEPHEDRINE GUAIFENESIN vs GUANFACINE GUAIFENESIN vs GUSELKUMAB GUAIFENESIN vs HAIR KERATIN AMINO ACIDS GOLD COMPLEX

Related Pages

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