Pharmacologic class (EPC) · 13 drug pages

Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor: adverse event reports filed with FDA

80,988 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

80,988
reports across the class: 0.4% of all reports; 2,367
reports, 12 months to June 2026: 3,490 in the 12 months before; 84.3%
marked serious by the reporter: 57.4% across all reports; 13
drugs with a page: brand and generic names counted separately

Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 13 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 80,988 adverse event reports received by FDA, 0.4% of the database, from January 2004 to June 2026.

2,367 reports arrived in the 12 months to June 2026, down 32% from 3,490 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 84.3% of the class's reports are marked serious, 6.6% record death among the outcomes and 16.7% record hospitalisation, as reported.

Across the class the reactions recorded most often are bone density decreased (24.9%), chronic kidney disease (15.5%) and renal injury (13.6%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
TruvadaEmtricitabine and tenofovir disoproxil fumarate	brand	38,638	844	85.7%	Bone density decreased
Zidovudine	generic	8,510	121	95%	Foetal exposure during pregnancy
BiktarvyBictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate	brand	6,739	677	54.7%	Weight increased
CompleraEmtricitabine, rilpivirine hydrochloride and tenofovir disoproxil fumarate	brand	6,535	95	86.9%	Bone density decreased
Emtricitabine	generic	3,870	73	97.7%	Foetal exposure during pregnancy
Abacavir	generic	3,867	108	95.3%	Virologic failure
Emtricitabine and tenofovir disoproxil fumarate	generic	3,518	5	98%	Maternal exposure during pregnancy
DescovyEmtricitabine and tenofovir alafenamide	brand	3,123	318	46.3%	Death
RetrovirZidovudine	brand	2,026	11	93.7%	Foetal exposure during pregnancy
ZiagenAbacavir sulfate	brand	1,554	7	90.3%	Pyrexia
OdefseyEmtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide	brand	1,035	33	51.9%	Weight increased
Abacavir sulfate	generic	840	66	98%	Exposure during pregnancy
EmtrivaEmtricitabine	brand	733	9	94.3%	Foetal exposure during pregnancy

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Bone density decreased24.9%20,184
Chronic kidney diseaselong-term kidney disease15.5%12,520
Renal injury13.6%10,977
Renal failurekidney failure13.5%10,923
Osteonecrosis13.3%10,775
Bone loss13.2%10,670
Tooth loss12.5%10,157
Skeletal injury12.3%9,948
Multiple fractures12%9,705
Osteoporosisthinning of the bones11.1%9,017
Painpain, site not specified10.5%8,464
Emotional distressemotional distress9.5%7,727
Anxietyanxiety9%7,300
Anhedonia8.4%6,829
Osteopenia6%4,877
Foetal exposure during pregnancythe unborn baby was exposed to the medicine5.6%4,564
Tooth injury5%4,065
Renal impairmentreduced kidney function3.6%2,932
Acute kidney injurysudden loss of kidney function3.6%2,915
Blood creatinine increasedraised creatinine, a kidney test3.4%2,717
Economic problema financial problem2.9%2,342
Exposure during pregnancythe medicine was taken during pregnancy2.5%2,027
Virologic failure2.3%1,870
Maternal exposure during pregnancythe mother took the medicine during pregnancy2.3%1,855
Deaththe patient died; cause not stated by this term2.2%1,798

Solid bar: share of all class reports. Hollow bar: the median share across the 13 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death6.6%5,329

Life-threatening2.3%1,867

Hospitalisation (initial or prolonged)16.7%13,544

Disability1.4%1,148

Congenital anomaly4.8%3,897

Other serious72%58,344

Not serious15.7%12,722

Patient age

Under 22.2%1,772

2 to 110.7%557

12 to 170.5%438

18 to 4424.7%20,028

45 to 6427.7%22,462

65 to 743%2,425

75 and over0.5%428

Age not given40.6%32,878

Who reported

Physician16.7%13,525

Pharmacist5.7%4,577

Other health professional22.9%18,576

Lawyer32%25,926

Consumer or non-health professional18.9%15,324

Not given3.8%3,060

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor reports

Which drugs are in the Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor class on this site?

Truvada, Zidovudine, Biktarvy, Complera, Emtricitabine and Abacavir and 7 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

80,988 reports through June 2026, 2,367 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

bone density decreased (24.9%), chronic kidney disease (15.5%), renal injury (13.6%), renal failure (13.5%) and osteonecrosis (13.3%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.