Does SERTRALINE Cause Spina bifida? 31 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 31 reports of Spina bifida have been filed in association with SERTRALINE (Sertraline Hydrochloride). This represents 0.1% of all adverse event reports for SERTRALINE.
31
Reports of Spina bifida with SERTRALINE
0.1%
of all SERTRALINE reports
3
Deaths
4
Hospitalizations
How Dangerous Is Spina bifida From SERTRALINE?
Of the 31 reports, 3 (9.7%) resulted in death, 4 (12.9%) required hospitalization, and 1 (3.2%) were considered life-threatening.
Is Spina bifida Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for SERTRALINE. However, 31 reports have been filed with the FAERS database.
What Other Side Effects Does SERTRALINE Cause?
Drug ineffective (4,439)
Toxicity to various agents (3,110)
Nausea (3,105)
Anxiety (2,981)
Dizziness (2,697)
Headache (2,597)
Intentional overdose (2,540)
Drug interaction (2,504)
Diarrhoea (2,424)
Fatigue (2,349)
What Other Drugs Cause Spina bifida?
OXYCODONE (268)
ACETAMINOPHEN\OXYCODONE (200)
ACETAMINOPHEN\HYDROCODONE (188)
HYDROMORPHONE (174)
MORPHINE (159)
LAMOTRIGINE (142)
TRAMADOL (136)
BUPRENORPHINE (107)
VALPROIC ACID (101)
HYDROCODONE (93)
Which SERTRALINE Alternatives Have Lower Spina bifida Risk?
SERTRALINE vs SETMELANOTIDE
SERTRALINE vs SEVELAMER
SERTRALINE vs SEVOFLURANE
SERTRALINE vs SIBUTRAMINE
SERTRALINE vs SILDENAFIL