STAVUDINE: 2,606 Adverse Event Reports & Safety Profile
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2,606
Total FAERS Reports
269 (10.3%)
Deaths Reported
422
Hospitalizations
2,606
As Primary/Secondary Suspect
100
Life-Threatening
39
Disabilities
Dec 29, 2008
FDA Approved
Discontinued
Status
Yes
Generic Available
FDA Application: 020412 ·
First Report: 1994 · Latest Report: 20221201
What Are the Most Common STAVUDINE Side Effects?
#1 Most Reported
Virologic failure
408 reports (15.7%)
#2 Most Reported
Drug resistance
361 reports (13.9%)
#3 Most Reported
Foetal exposure during pregnancy
343 reports (13.2%)
All STAVUDINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Virologic failure | 408 | 15.7% | 21 | 15 |
| Drug resistance | 361 | 13.9% | 21 | 14 |
| Foetal exposure during pregnancy | 343 | 13.2% | 15 | 101 |
| Lipodystrophy acquired | 283 | 10.9% | 0 | 31 |
| Viral mutation identified | 258 | 9.9% | 2 | 0 |
| Treatment failure | 255 | 9.8% | 29 | 6 |
| Pathogen resistance | 196 | 7.5% | 4 | 8 |
| Mitochondrial toxicity | 180 | 6.9% | 1 | 3 |
| Eyelid ptosis | 168 | 6.5% | 0 | 0 |
| Diplopia | 166 | 6.4% | 0 | 0 |
| Pregnancy | 131 | 5.0% | 9 | 25 |
| Blood lactic acid increased | 112 | 4.3% | 0 | 57 |
| Anaemia | 111 | 4.3% | 8 | 67 |
| Dysphagia | 95 | 3.7% | 0 | 3 |
| Immune reconstitution inflammatory syndrome | 94 | 3.6% | 8 | 36 |
| Multiple-drug resistance | 94 | 3.6% | 0 | 8 |
| Lactic acidosis | 86 | 3.3% | 24 | 28 |
| Exposure during pregnancy | 83 | 3.2% | 4 | 6 |
| Premature baby | 82 | 3.2% | 7 | 18 |
| Death | 77 | 3.0% | 77 | 7 |
Who Reports STAVUDINE Side Effects? Age & Gender Data
Gender: 39.7% female, 60.3% male. Average age: 38.2 years. Most reports from: US. View detailed demographics →
Is STAVUDINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 84 | 7 | 36 |
| 2001 | 97 | 5 | 27 |
| 2002 | 45 | 9 | 16 |
| 2003 | 34 | 5 | 5 |
| 2004 | 33 | 3 | 12 |
| 2005 | 34 | 4 | 12 |
| 2006 | 10 | 1 | 1 |
| 2007 | 11 | 6 | 8 |
| 2008 | 16 | 2 | 1 |
| 2009 | 20 | 1 | 4 |
| 2010 | 12 | 0 | 3 |
| 2011 | 27 | 1 | 7 |
| 2012 | 19 | 3 | 6 |
| 2013 | 5 | 0 | 0 |
| 2014 | 48 | 3 | 20 |
| 2015 | 11 | 1 | 5 |
| 2016 | 1 | 0 | 1 |
| 2017 | 3 | 0 | 0 |
| 2018 | 10 | 0 | 6 |
| 2019 | 3 | 0 | 1 |
| 2020 | 5 | 0 | 0 |
| 2021 | 4 | 0 | 3 |
| 2022 | 3 | 0 | 0 |
What Is STAVUDINE Used For?
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Official FDA Label for STAVUDINE
Official prescribing information from the FDA-approved drug label.