Does PHENOBARBITAL Cause Product use in unapproved indication? 230 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 230 reports of Product use in unapproved indication have been filed in association with PHENOBARBITAL (Phenobarbital Sodium). This represents 3.6% of all adverse event reports for PHENOBARBITAL.
230
Reports of Product use in unapproved indication with PHENOBARBITAL
3.6%
of all PHENOBARBITAL reports
20
Deaths
139
Hospitalizations
How Dangerous Is Product use in unapproved indication From PHENOBARBITAL?
Of the 230 reports, 20 (8.7%) resulted in death, 139 (60.4%) required hospitalization, and 49 (21.3%) 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 PHENOBARBITAL. However, 230 reports have been filed with the FAERS database.
What Other Side Effects Does PHENOBARBITAL Cause?
Drug ineffective (1,686)
Off label use (781)
Seizure (620)
Multiple-drug resistance (406)
Toxicity to various agents (392)
Status epilepticus (317)
Drug reaction with eosinophilia and systemic symptoms (274)
Foetal exposure during pregnancy (266)
Hypotension (256)
Epilepsy (253)
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 PHENOBARBITAL Alternatives Have Lower Product use in unapproved indication Risk?
PHENOBARBITAL vs PHENOLPHTHALEIN
PHENOBARBITAL vs PHENOTHIAZINE
PHENOBARBITAL vs PHENPROCOUMON
PHENOBARBITAL vs PHENTERMINE
PHENOBARBITAL vs PHENTERMINE\TOPIRAMATE