Does AMIODARONE Cause Stomatitis? 12 Reports in FDA Database

Q: Does AMIODARONE cause Stomatitis?

12 reports of Stomatitis have been filed with the FDA for AMIODARONE, representing 0.1% of all AMIODARONE adverse event reports.

Q: How dangerous is Stomatitis from AMIODARONE?

Of 12 reports, 3 (25.0%) resulted in death and 10 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 12 reports of Stomatitis have been filed in association with AMIODARONE (Amiodarone Hydrochloride). This represents 0.1% of all adverse event reports for AMIODARONE.

Reports of Stomatitis with AMIODARONE

0.1%

of all AMIODARONE reports

Deaths

Hospitalizations

How Dangerous Is Stomatitis From AMIODARONE?

Of the 12 reports, 3 (25.0%) resulted in death, 10 (83.3%) required hospitalization, and 2 (16.7%) were considered life-threatening.

Is Stomatitis Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for AMIODARONE. However, 12 reports have been filed with the FAERS database.

What Other Side Effects Does AMIODARONE Cause?

Drug ineffective (2,223) Dyspnoea (2,182) Off label use (1,608) Drug interaction (1,589) Asthenia (1,452) Interstitial lung disease (1,421) Hyperthyroidism (1,410) Fatigue (1,269) Bradycardia (1,261) Atrial fibrillation (1,211)

What Other Drugs Cause Stomatitis?

METHOTREXATE (7,245) TOCILIZUMAB (4,761) ADALIMUMAB (4,500) LEFLUNOMIDE (4,492) ABATACEPT (4,481) ETANERCEPT (4,338) RITUXIMAB (4,335) CERTOLIZUMAB PEGOL (3,760) INFLIXIMAB (3,713) PREDNISONE (3,656)

Which AMIODARONE Alternatives Have Lower Stomatitis Risk?

AMIODARONE vs AMISULPRIDE AMIODARONE vs AMITRIPTYLINE AMIODARONE vs AMITRIPTYLINE\PERPHENAZINE AMIODARONE vs AMIVANTAMAB AMIODARONE vs AMIVANTAMAB-VMJW

AMIODARONE Full Profile All Stomatitis Reports All Drugs Causing Stomatitis AMIODARONE Demographics