Does BACLOFEN Cause Hypotonia? 481 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 481 reports of Hypotonia have been filed in association with BACLOFEN (BACLOFEN). This represents 1.9% of all adverse event reports for BACLOFEN.
481
Reports of Hypotonia with BACLOFEN
1.9%
of all BACLOFEN reports
7
Deaths
255
Hospitalizations
How Dangerous Is Hypotonia From BACLOFEN?
Of the 481 reports, 7 (1.5%) resulted in death, 255 (53.0%) required hospitalization, and 53 (11.0%) were considered life-threatening.
Is Hypotonia Listed in the Official Label?
Yes, Hypotonia is listed as a known adverse reaction in the official FDA drug label for BACLOFEN.
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 Hypotonia?
VALPROATE (234)
QUETIAPINE (186)
LAMOTRIGINE (149)
OLANZAPINE (138)
CLONAZEPAM (130)
DIAZEPAM (130)
VENLAFAXINE (129)
SERTRALINE (122)
RISPERIDONE (121)
LEVETIRACETAM (108)
Which BACLOFEN Alternatives Have Lower Hypotonia Risk?
BACLOFEN vs BACLOFEN INTRATHECAL
BACLOFEN vs BACTRIM
BACLOFEN vs BALOXAVIR MARBOXIL
BACLOFEN vs BALSALAZIDE
BACLOFEN vs BAMLANIVIMAB