Retrovirzidovudine
According to the FDA label: RETROVIR is a nucleoside analogue reverse transcriptase inhibitor indicated for: • Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents. ( 1.1 ) • Prevention of maternal-fetal HIV-1 transmission. ( 1.2 ) 1.1 Treatment of HIV-1 RETROVIR, a nucleoside reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
13,223 adverse event reports submitted to the FDA (1998–2026)
Top Reported Adverse Events
The most frequently reported events in association with Retrovir 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 2,131 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 →Drug Exposure During Pregnancy 1,075 reports
A report noting that a person was exposed to a medication during pregnancy. This is a tracking category for monitoring, not a description of harm by itself.
Full definition in the glossary →Anaemia 935 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 →- Virologic Failure 814 reports
Drug Resistance 726 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 →- Premature Baby 722 reports
Exposure During Pregnancy 642 reports
A report noting that a person was exposed to a medication during pregnancy. This is a tracking category for monitoring, not a description of harm by itself.
Full definition in the glossary →- Pathogen Resistance 573 reports
- Viral Mutation Identified 567 reports
Maternal Exposure During Pregnancy 508 reports
A report noting that a pregnant person was exposed to a medication. This is a tracking category for monitoring use during pregnancy, not a description of harm by itself.
Full definition in the glossary →Pyrexia 469 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →- Lipodystrophy Acquired 435 reports
Pain 427 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Treatment Failure 423 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 →Neutropenia 414 reports
A low level of neutrophils, a type of white blood cell that fights infection.
Full definition in the glossary →
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 | 5,190 |
| Female | 4,221 |
| Unknown | 146 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 1,713 |
| 18-34 | 1,590 |
| 35-49 | 2,016 |
| 50-64 | 1,205 |
| 65-74 | 127 |
| 75+ | 52 |
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 Retrovir. 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 | 8,929 |
| Hospitalization | 3,321 |
| Death | 1,633 |
| Non-Serious | 715 |
| Life-Threatening | 557 |
| Disability | 254 |
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 Retrovir. 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 |
|---|---|
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 1 |
| 2002 | 3 |
| 2003 | 8 |
| 2004 | 544 |
| 2005 | 542 |
| 2006 | 791 |
| 2007 | 608 |
| 2008 | 580 |
| 2009 | 630 |
| 2010 | 597 |
| 2011 | 464 |
| 2012 | 423 |
| 2013 | 408 |
| 2014 | 457 |
| 2015 | 697 |
| 2016 | 1,264 |
| 2017 | 987 |
| 2018 | 834 |
| 2019 | 722 |
| 2020 | 908 |
| 2021 | 541 |
| 2022 | 460 |
| 2023 | 398 |
| 2024 | 193 |
| 2025 | 147 |
| 2026 (partial) | 13 |
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 Retrovir
In FDA adverse event reports that mention Retrovir, these medications appeared most often in the same report.
- Nevirapine (3,318 reports)
- Ritonavir (3,234 reports)
- Efavirenz (2,210 reports)
- Lopinavir And Ritonavir (1,822 reports)
- Abacavir (1,817 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