Epivirlamivudine
According to the FDA label: EPIVIR is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection. Limitations of Use: • The dosage of this product is for HIV‑1 and not for HBV. EPIVIR is a nucleoside analogue reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV‑1 infection. Limitations of Use: The dosage of this product is for HIV‑1 and not for HBV. ( 1 )
30,530 adverse event reports submitted to the FDA (1999–2026)
Top Reported Adverse Events
The most frequently reported events in association with Epivir in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Foetal Exposure During Pregnancy 2,014 reports
A report noting that a developing baby was exposed to a medication during pregnancy. This is a tracking category for monitoring, not a description of harm by itself. Also spelled fetal in American English.
Full definition in the glossary →- Virologic Failure 1,951 reports
Drug Resistance 1,943 reports
A situation where a medication becomes less effective against the condition it was meant to treat, such as an infection no longer responding to an antibiotic.
Full definition in the glossary →Drug Interaction 1,858 reports
A report that two or more medications may have affected each other when taken together.
Full definition in the glossary →- Pathogen Resistance 1,724 reports
- Viral Mutation Identified 1,666 reports
Depression 1,337 reports
A persistent low mood, loss of interest, or feelings of sadness. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary → See all drugs reporting this event →Pyrexia 1,273 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 1,140 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Anaemia 1,119 reports
A condition where there are too few healthy red blood cells to carry enough oxygen, often causing tiredness and paleness. Also spelled anemia in American English.
Full definition in the glossary → See all drugs reporting this event →Pain 1,112 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Nausea 1,057 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Treatment Failure 1,014 reports
A report that the treatment did not produce the expected result. Similar to drug ineffective, it reflects that someone felt the treatment was not working.
Full definition in the glossary →Vomiting 1,005 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Anxiety 986 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 14,498 |
| Female | 8,330 |
| Unknown | 183 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 1,829 |
| 18-34 | 3,082 |
| 35-49 | 5,932 |
| 50-64 | 5,266 |
| 65-74 | 1,365 |
| 75+ | 560 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Epivir. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 21,998 |
| Hospitalization | 9,261 |
| Death | 4,061 |
| Life-Threatening | 1,360 |
| Non-Serious | 1,201 |
| Disability | 647 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Epivir. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 1999 | 2 |
| 2002 | 3 |
| 2003 | 9 |
| 2004 | 1,144 |
| 2005 | 1,220 |
| 2006 | 1,265 |
| 2007 | 1,049 |
| 2008 | 1,114 |
| 2009 | 1,084 |
| 2010 | 763 |
| 2011 | 670 |
| 2012 | 757 |
| 2013 | 670 |
| 2014 | 805 |
| 2015 | 1,613 |
| 2016 | 2,262 |
| 2017 | 2,126 |
| 2018 | 2,120 |
| 2019 | 2,247 |
| 2020 | 2,541 |
| 2021 | 1,842 |
| 2022 | 1,852 |
| 2023 | 1,695 |
| 2024 | 863 |
| 2025 | 717 |
| 2026 (partial) | 97 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Epivir
In FDA adverse event reports that mention Epivir, these medications appeared most often in the same report.
- Zidovudine (7,774 reports)
- Tenofovir Disoproxil (6,120 reports)
- Abacavir (5,894 reports)
- Ritonavir (5,601 reports)
- Efavirenz (5,525 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026