BREXANOLONE for Status epilepticus: Side Effects & Safety Data
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There are 10 adverse event reports in the FDA FAERS database where BREXANOLONE was used for Status epilepticus.
Most Reported Side Effects for BREXANOLONE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Product administration error | 36 | 13.8% | 0 | 1 |
| Anxiety | 34 | 13.0% | 0 | 0 |
| Drug ineffective | 26 | 10.0% | 1 | 4 |
| Off label use | 24 | 9.2% | 0 | 1 |
| Drug monitoring procedure incorrectly performed | 19 | 7.3% | 0 | 0 |
| Fatigue | 17 | 6.5% | 0 | 1 |
| Dizziness | 16 | 6.1% | 0 | 0 |
| Perinatal depression | 15 | 5.8% | 0 | 1 |
| Crying | 14 | 5.4% | 0 | 0 |
| Product administration interrupted | 14 | 5.4% | 0 | 1 |
| Feeling abnormal | 13 | 5.0% | 0 | 0 |
| Incorrect product administration duration | 12 | 4.6% | 0 | 1 |
| Therapeutic product effect incomplete | 12 | 4.6% | 0 | 0 |
| Headache | 11 | 4.2% | 0 | 0 |
| Somnolence | 11 | 4.2% | 0 | 0 |
Other Indications for BREXANOLONE
Perinatal depression (216)
Product used for unknown indication (10)
Seizure (7)
Major depression (5)
Other Drugs Used for Status epilepticus
LEVETIRACETAM (2,650)
LACOSAMIDE (1,445)
PHENYTOIN (1,080)
MIDAZOLAM (1,053)
VALPROIC ACID (854)
PROPOFOL (752)
CANNABIDIOL (698)
PHENOBARBITAL (655)
LORAZEPAM (474)
TOPIRAMATE (454)