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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 AMBROXOL Cause Off label use? 138 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 138 reports of Off label use have been filed in association with AMBROXOL. This represents 15.2% of all adverse event reports for AMBROXOL.

138
Reports of Off label use with AMBROXOL
15.2%
of all AMBROXOL reports
2
Deaths
120
Hospitalizations

How Dangerous Is Off label use From AMBROXOL?

Of the 138 reports, 2 (1.4%) resulted in death, 120 (87.0%) required hospitalization, and 17 (12.3%) 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 AMBROXOL. However, 138 reports have been filed with the FAERS database.

What Other Side Effects Does AMBROXOL Cause?

Dyspnoea (169) Drug ineffective (149) Cough (141) Chest discomfort (134) Nasopharyngitis (128) Atrial fibrillation (125) Dyspnoea exertional (122) Dysphonia (121) Wheezing (121) Obstructive airways disorder (113)

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 AMBROXOL Alternatives Have Lower Off label use Risk?

AMBROXOL vs AMDINOCILLIN PIVOXIL AMBROXOL vs AMG-510 AMBROXOL vs AMIFAMPRIDINE AMBROXOL vs AMIFOSTINE AMBROXOL vs AMIKACIN

Related Pages

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