Does BACLOFEN Cause Off label use? 1,454 Reports in FDA Database

Q: Does BACLOFEN cause Off label use?

1,454 reports of Off label use have been filed with the FDA for BACLOFEN, representing 5.7% of all BACLOFEN adverse event reports.

Q: How dangerous is Off label use from BACLOFEN?

Of 1,454 reports, 134 (9.2%) resulted in death and 589 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 1,454 reports of Off label use have been filed in association with BACLOFEN (BACLOFEN). This represents 5.7% of all adverse event reports for BACLOFEN.

1,454

Reports of Off label use with BACLOFEN

5.7%

of all BACLOFEN reports

134

Deaths

589

Hospitalizations

How Dangerous Is Off label use From BACLOFEN?

Of the 1,454 reports, 134 (9.2%) resulted in death, 589 (40.5%) required hospitalization, and 87 (6.0%) 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 BACLOFEN. However, 1,454 reports have been filed with the FAERS database.

What Other Side Effects Does BACLOFEN Cause?

Muscle spasticity (2,893) Drug withdrawal syndrome (2,284) Pain (2,048) Toxicity to various agents (1,868) Overdose (1,554) Drug ineffective (1,445) Somnolence (1,433) Muscle spasms (1,279) Coma (1,133) Completed suicide (1,112)

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 BACLOFEN Alternatives Have Lower Off label use Risk?

BACLOFEN vs BACLOFEN INTRATHECAL BACLOFEN vs BACTRIM BACLOFEN vs BALOXAVIR MARBOXIL BACLOFEN vs BALSALAZIDE BACLOFEN vs BAMLANIVIMAB

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