Does IBUPROFEN Cause Hypotonia? 58 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 58 reports of Hypotonia have been filed in association with IBUPROFEN (equate ibuprofen). This represents 0.1% of all adverse event reports for IBUPROFEN.
58
Reports of Hypotonia with IBUPROFEN
0.1%
of all IBUPROFEN reports
12
Deaths
28
Hospitalizations
How Dangerous Is Hypotonia From IBUPROFEN?
Of the 58 reports, 12 (20.7%) resulted in death, 28 (48.3%) required hospitalization, and 11 (19.0%) were considered life-threatening.
Is Hypotonia Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for IBUPROFEN. However, 58 reports have been filed with the FAERS database.
What Other Side Effects Does IBUPROFEN Cause?
Drug ineffective (9,352)
Drug hypersensitivity (5,269)
Nausea (4,129)
Vomiting (4,116)
Acute kidney injury (3,639)
Product use in unapproved indication (3,596)
Toxicity to various agents (3,584)
Off label use (3,556)
Intentional overdose (3,185)
Headache (3,010)
What Other Drugs Cause Hypotonia?
BACLOFEN (481)
VALPROATE (234)
QUETIAPINE (186)
LAMOTRIGINE (149)
OLANZAPINE (138)
CLONAZEPAM (130)
DIAZEPAM (130)
VENLAFAXINE (129)
SERTRALINE (122)
RISPERIDONE (121)
Which IBUPROFEN Alternatives Have Lower Hypotonia Risk?
IBUPROFEN vs IBUPROFEN LYSINE
IBUPROFEN vs IBUPROFEN UNKNOWN PRODUCT
IBUPROFEN vs IBUPROFEN\IBUPROFEN
IBUPROFEN vs IBUPROFEN\PHENYLEPHRINE
IBUPROFEN vs IBUPROFEN\PSEUDOEPHEDRINE