Pharmacologic class (EPC) · 12 drug pages

Hepatitis B virus nucleoside analog reverse transcriptase inhibitor: adverse event reports filed with FDA

72,523 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.

72,523
reports across the class: 0.4% of all reports; 1,313
reports, 12 months to June 2026: 2,703 in the 12 months before; 88.4%
marked serious by the reporter: 57.4% across all reports; 12
drugs with a page: brand and generic names counted separately

Hepatitis B virus nucleoside analog reverse transcriptase inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 12 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 72,523 adverse event reports received by FDA, 0.4% of the database, from January 2004 to June 2026.

1,313 reports arrived in the 12 months to June 2026, down 51% from 2,703 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 88.4% of the class's reports are marked serious, 8.9% record death among the outcomes and 20% record hospitalisation, as reported.

Across the class the reactions recorded most often are bone density decreased (14.9%), renal injury (12.9%) and skeletal injury (11.5%). 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
VireadTenofovir disoproxil fumarate	brand	22,033	195	94.5%	Bone density decreased
Lamivudine	generic	17,966	271	97.6%	Virologic failure
Tenofovir disoproxil fumarate	generic	7,400	150	97.4%	Virologic failure
TriumeqAbacavir sulfate, dolutegravir sodium, lamivudine	brand	4,823	81	45.7%	Product dose omission issue
CombivirLamivudine and zidovudine	brand	4,367	11	92.2%	Drug exposure during pregnancy
BaracludeEntecavir	brand	3,308	25	77.8%	Death
EpivirLamivudine	brand	3,208	14	93.1%	Foetal exposure during pregnancy
DovatoDolutegravir sodium and lamivudine	brand	3,059	253	33.4%	Product dose omission issue
Entecavir	generic	2,797	163	87.1%	Drug resistance
Lamivudine and zidovudine	generic	1,432	8	84.2%	Foetal exposure during pregnancy
Adefovir dipivoxil	generic	1,156	3	99.2%	Drug resistance
Tenofovir alafenamide	generic	974	139	97.3%	Death

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 decreased14.9%10,788
Renal injury12.9%9,351
Skeletal injury11.5%8,333
Chronic kidney diseaselong-term kidney disease10.3%7,467
Osteonecrosis10.3%7,441
Renal failurekidney failure9.9%7,148
Bone loss9.8%7,090
Multiple fractures9.5%6,879
Osteoporosisthinning of the bones8%5,797
Tooth loss6.2%4,529
Foetal exposure during pregnancythe unborn baby was exposed to the medicine5.3%3,831
Painpain, site not specified4.7%3,413
Drug resistance4.5%3,279
Virologic failure4.2%3,010
Anxietyanxiety4.1%2,984
Pathogen resistance4.1%2,950
Emotional distressemotional distress4%2,875
Viral mutation identified3.8%2,781
Anhedonia3.4%2,464
Osteopenia3.2%2,304
Renal impairmentreduced kidney function3.1%2,256
Drug ineffectivethe medicine did not work as expected2.9%2,100
Tooth injury2.8%2,036
Blood creatinine increasedraised creatinine, a kidney test2.8%2,025
Product dose omission issuea dose was missed2.7%1,957

Solid bar: share of all class reports. Hollow bar: the median share across the 12 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death8.9%6,434

Life-threatening2.5%1,836

Hospitalisation (initial or prolonged)20%14,528

Disability1.4%1,037

Congenital anomaly4.9%3,521

Other serious73.7%53,448

Not serious11.6%8,408

Patient age

Under 22%1,425

2 to 110.8%582

12 to 170.7%486

18 to 4422%15,923

45 to 6425.4%18,392

65 to 744.3%3,114

75 and over1.3%965

Age not given43.6%31,636

Who reported

Physician20.7%15,044

Pharmacist3.9%2,808

Other health professional31.5%22,875

Lawyer18.4%13,355

Consumer or non-health professional21.1%15,270

Not given4.4%3,171

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 Hepatitis B virus nucleoside analog reverse transcriptase inhibitor reports

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

Viread, Lamivudine, Tenofovir disoproxil fumarate, Triumeq, Combivir and Baraclude and 6 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

72,523 reports through June 2026, 1,313 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 (14.9%), renal injury (12.9%), skeletal injury (11.5%), chronic kidney disease (10.3%) and osteonecrosis (10.3%).

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.