AMPRENAVIR: 109 Adverse Event Reports & Safety Profile
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109
Total FAERS Reports
4 (3.7%)
Deaths Reported
16
Hospitalizations
109
As Primary/Secondary Suspect
2
Life-Threatening
6
Disabilities
Apr 15, 1999
FDA Approved
Discontinued
Status
FDA Application: 021007 ·
First Report: 199804 · Latest Report: 20210101
What Are the Most Common AMPRENAVIR Side Effects?
#1 Most Reported
Virologic failure
36 reports (33.0%)
#2 Most Reported
Viral mutation identified
34 reports (31.2%)
#3 Most Reported
Treatment failure
24 reports (22.0%)
All AMPRENAVIR Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Virologic failure | 36 | 33.0% | 0 | 7 |
| Viral mutation identified | 34 | 31.2% | 0 | 0 |
| Drug resistance | 24 | 22.0% | 1 | 0 |
| Pathogen resistance | 24 | 22.0% | 0 | 0 |
| Treatment failure | 24 | 22.0% | 0 | 0 |
| Pancytopenia | 13 | 11.9% | 0 | 7 |
| Drug ineffective | 11 | 10.1% | 1 | 6 |
| Toxicity to various agents | 11 | 10.1% | 0 | 7 |
| Dysuria | 10 | 9.2% | 0 | 7 |
| Hiv infection | 10 | 9.2% | 0 | 7 |
| Immunodeficiency | 10 | 9.2% | 0 | 7 |
| Kaposi's sarcoma | 10 | 9.2% | 0 | 7 |
| Laboratory test abnormal | 10 | 9.2% | 0 | 7 |
| Lymphoedema | 10 | 9.2% | 0 | 7 |
| Multiple-drug resistance | 10 | 9.2% | 0 | 7 |
| Skin lesion | 10 | 9.2% | 0 | 7 |
| Urinary tract infection | 10 | 9.2% | 0 | 7 |
| Foetal exposure during pregnancy | 9 | 8.3% | 0 | 3 |
| Neoplasm progression | 9 | 8.3% | 0 | 6 |
| Pyrexia | 9 | 8.3% | 0 | 6 |
Who Reports AMPRENAVIR Side Effects? Age & Gender Data
Gender: 25.0% female, 75.0% male. Average age: 44.0 years. Most reports from: US. View detailed demographics →
Is AMPRENAVIR Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 3 | 0 | 1 |
| 2001 | 1 | 0 | 0 |
| 2002 | 1 | 0 | 1 |
| 2004 | 2 | 0 | 0 |
| 2005 | 3 | 0 | 3 |
| 2006 | 2 | 0 | 0 |
| 2009 | 5 | 0 | 0 |
| 2011 | 3 | 0 | 0 |
| 2018 | 7 | 0 | 4 |
| 2021 | 3 | 0 | 3 |
What Is AMPRENAVIR Used For?
| Indication | Reports |
|---|---|
| Hiv infection | 93 |
| Product used for unknown indication | 6 |
AMPRENAVIR vs Alternatives: Which Is Safer?
AMPRENAVIR vs AMPYRA
AMPRENAVIR vs AMRUBICIN
AMPRENAVIR vs AMSACRINE
AMPRENAVIR vs ANAGRELIDE
AMPRENAVIR vs ANAKINRA
AMPRENAVIR vs ANAMORELIN
AMPRENAVIR vs ANASTROZOLE
AMPRENAVIR vs ANDEXANET ALFA
AMPRENAVIR vs ANDROGEL
AMPRENAVIR vs ANETHOLTRITHION
Official FDA Label for AMPRENAVIR
Official prescribing information from the FDA-approved drug label.