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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ISENTRESS: 234 Adverse Event Reports & Safety Profile

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234
Total FAERS Reports
29 (12.4%)
Deaths Reported
95
Hospitalizations
234
As Primary/Secondary Suspect
14
Life-Threatening
14
Disabilities

First Report: 2000 · Latest Report: 20140609

What Are the Most Common ISENTRESS Side Effects?

#1 Most Reported
Foetal exposure during pregnancy
25 reports (10.7%)
#2 Most Reported
Exposure during pregnancy
18 reports (7.7%)
#3 Most Reported
Wrong technique in drug usage process
11 reports (4.7%)

All ISENTRESS Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Foetal exposure during pregnancy 25 10.7% 4 9
Exposure during pregnancy 18 7.7% 0 2
Wrong technique in drug usage process 11 4.7% 4 5
Pneumonia 10 4.3% 5 8
Death 9 3.9% 9 2
Lipodystrophy acquired 9 3.9% 0 4
Renal failure acute 8 3.4% 5 6
Abortion spontaneous 7 3.0% 0 0
Adverse event 7 3.0% 1 6
Hypotension 7 3.0% 7 6
Rhabdomyolysis 7 3.0% 0 2
Drug dose omission 6 2.6% 1 2
Drug interaction 6 2.6% 1 1
Hyperkalaemia 6 2.6% 1 3
No adverse event 6 2.6% 0 0
Status epilepticus 6 2.6% 0 6
Anaemia 5 2.1% 4 3
Dysphagia 5 2.1% 0 4
Hypotonia 5 2.1% 3 2
Metabolic acidosis 5 2.1% 5 4

Who Reports ISENTRESS Side Effects? Age & Gender Data

Average age: 44.5 years. Most reports from: US. View detailed demographics →

Is ISENTRESS Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 2 0 2
2009 2 0 1
2010 5 1 2
2011 11 0 9
2012 18 2 12
2013 68 11 42
2014 37 3 12

View full timeline →

What Is ISENTRESS Used For?

IndicationReports
Hiv infection 128
Antiretroviral therapy 12
Product used for unknown indication 12
Maternal exposure timing unspecified 9
Hiv test positive 5

ISENTRESS vs Alternatives: Which Is Safer?

ISENTRESS vs ISOFLURANE ISENTRESS vs ISONIAZID ISENTRESS vs ISONIAZID\PYRAZINAMIDE\RIFAMPIN ISENTRESS vs ISONIAZID\PYRIDOXINE\SULFAMETHOXAZOLE\TRIMETHOPRIM ISENTRESS vs ISONIAZID\RIFAMPIN ISENTRESS vs ISOPROPANOLAMINE ISENTRESS vs ISOPROPYL ALCOHOL ISENTRESS vs ISOPROPYL ALCOHOL\LEUPROLIDE ISENTRESS vs ISOPROPYL ALCOHOL\LEUPROLIDE\NORETHINDRONE ISENTRESS vs ISOPROTERENOL

Official FDA Label for ISENTRESS

Official prescribing information from the FDA-approved drug label.