Does BACLOFEN Cause Sedation? 343 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 343 reports of Sedation have been filed in association with BACLOFEN (BACLOFEN). This represents 1.3% of all adverse event reports for BACLOFEN.
343
Reports of Sedation with BACLOFEN
1.3%
of all BACLOFEN reports
26
Deaths
168
Hospitalizations
How Dangerous Is Sedation From BACLOFEN?
Of the 343 reports, 26 (7.6%) resulted in death, 168 (49.0%) required hospitalization, and 25 (7.3%) were considered life-threatening.
Is Sedation Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for BACLOFEN. However, 343 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)
Off label use (1,454)
Drug ineffective (1,445)
Somnolence (1,433)
Muscle spasms (1,279)
Coma (1,133)
What Other Drugs Cause Sedation?
ESKETAMINE (2,244)
OLANZAPINE (2,130)
QUETIAPINE (2,051)
RISPERIDONE (1,863)
CLOZAPINE (1,748)
ARIPIPRAZOLE (1,603)
MORPHINE (1,265)
GABAPENTIN (980)
AMITRIPTYLINE (975)
PALIPERIDONE (873)
Which BACLOFEN Alternatives Have Lower Sedation Risk?
BACLOFEN vs BACLOFEN INTRATHECAL
BACLOFEN vs BACTRIM
BACLOFEN vs BALOXAVIR MARBOXIL
BACLOFEN vs BALSALAZIDE
BACLOFEN vs BAMLANIVIMAB