Does AMIODARONE Cause Product use in unapproved indication? 893 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 893 reports of Product use in unapproved indication have been filed in association with AMIODARONE (Amiodarone Hydrochloride). This represents 3.6% of all adverse event reports for AMIODARONE.
893
Reports of Product use in unapproved indication with AMIODARONE
3.6%
of all AMIODARONE reports
255
Deaths
432
Hospitalizations
How Dangerous Is Product use in unapproved indication From AMIODARONE?
Of the 893 reports, 255 (28.6%) resulted in death, 432 (48.4%) required hospitalization, and 212 (23.7%) were considered life-threatening.
Is Product use in unapproved indication Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for AMIODARONE. However, 893 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 Product use in unapproved indication?
DUPILUMAB (33,452)
DICLOFENAC (12,197)
METHOTREXATE (8,930)
PREDNISONE (7,625)
RITUXIMAB (7,519)
MYCOPHENOLATE MOFETIL (5,910)
ACETAMINOPHEN (5,819)
CYCLOPHOSPHAMIDE (5,750)
RISPERIDONE (5,551)
TACROLIMUS (5,057)
Which AMIODARONE Alternatives Have Lower Product use in unapproved indication Risk?
AMIODARONE vs AMISULPRIDE
AMIODARONE vs AMITRIPTYLINE
AMIODARONE vs AMITRIPTYLINE\PERPHENAZINE
AMIODARONE vs AMIVANTAMAB
AMIODARONE vs AMIVANTAMAB-VMJW