Prescription medicine
Adefovir dipivoxil First approved as Hepsera
Adefovir dipivoxil (Hepsera) is a prescription medicine with an FDA approval on record since 2002. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $21.73 per adefovir dipivoxil 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the adefovir dipivoxil FDA label on DailyMed (effective July 22, 2025, Apotex Corp.); the NDA 21449 record on Drugs@FDA; every adefovir dipivoxil label on DailyMed.
Highlights of the record
FDA label of July 22, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SEVERE ACUTE EXACERBATIONS OF HEPATITIS, NEPHROTOXICITY, HIV RESISTANCE, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS.
Severe acute exacerbations of hepatitis have been reported in patients who have discontinued anti-Hepatitis B therapy including adefovir dipivoxil tablets. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-Hepatitis B therapy. If appropriate, resumption of anti-Hepatitis B therapy may be warranted [See Warnings and Precautions (5. 1 ) ]. In patients at risk of or having underlying renal dysfunction, chronic administration of adefovir dipivoxil tablets may result in nephrotoxicity. These patients should be monitored closely for renal function and may require dose adjustment [See Warnings and Precautions (5. 2 ) and Dosage and Administration (2.2) ]. HIV resistance may emerge in chronic hepatitis B patients with unrecognized or untreated Human Immunodeficiency Virus (HIV) infection treated with anti-hepatitis B therapies, such as therapy with adefovir dipivoxil tablets, that may have activity against HIV [See Warnings and Precautions (5. 3 ) ]. […]
Used for
From the label: indications and usageAdefovir dipivoxil tablets are indicated for the treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
Forms and strengths
- 10 mg
Tablet.
On the market
- Earliest approval on file
- September 20, 2002 Hepsera, Gilead; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first August 29, 2013; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 2 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $21.73 per tablet Adefovir dipivoxil 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,270 through July 30, 2026
What is adefovir dipivoxil used for?
From the label: indications and usageAdefovir dipivoxil tablets are indicated for the treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. This indication is based on histological, virological, biochemical, and serological responses in adult patients with HBeAg+ and HBeAg- chronic hepatitis B with compensated liver function, and with clinical evidence of lamivudine-resistant hepatitis B virus with either compensated or decompensated liver function. […]
Conditions named in the indications of adefovir dipivoxil's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor.
Source: FDA drug label (Adefovir dipivoxil), Apotex Corp., effective July 22, 2025 (SPL set 08e07fae-3191-b6a3-c894-d3a8cc53923f), via openFDA; the full label on DailyMed
What does the patient leaflet for adefovir dipivoxil say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about adefovir dipivoxil tablets?Adefovir dipivoxil tablets can cause serious side effects, including: Worsening of hepatitis B infection. Your hepatitis B (HBV) infection may become worse (flare-up) if you take adefovir dipivoxil tablets and then stop taking it. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. Do not run out of adefovir dipivoxil tablets. Refill your prescription or talk to your doctor before your adefovir dipivoxil tablets is all gone. Do not stop taking adefovir dipivoxil tablets without first talking with your doctor. If you stop taking adefovir dipivoxil tablets, your doctor will need to check your health often and do blood tests regularly to check your HBV infection for at least several months. Adefovir dipivoxil tablets may cause severe kidney problem. […] Call your doctor right away if you get any of the following signs or symptoms of liver problems. your skin or the white part of your eyes turns yellow (jaundice). dark or “tea-colored” urine light-colored stools (bowel movements) nausea loss of appetite for several days or longer pain, aching, or tenderness on the right side of your stomach-area You may be more likely to get lactic acidosis or serious liver problems if you are female, are very overweight (obese), or have been taking nucleoside analog medicines for a long time. […]
From the patient leaflet: How should I store adefovir dipivoxil tablets?Adefovir dipivoxil tablets should be stored at 20°C to 25°C (68°F to 77°F). Keep adefovir dipivoxil tablets in its original container. Do not use adefovir dipivoxil tablets if the seal over the bottle is broken or missing when you receive it. Keep adefovir dipivoxil tablets and all medicines out of the reach of children.
Source: FDA drug label (Adefovir dipivoxil), Apotex Corp., effective July 22, 2025 (SPL set 08e07fae-3191-b6a3-c894-d3a8cc53923f), via openFDA; the full label on DailyMed
Is there a generic for adefovir dipivoxil (Hepsera)?
The FDA approved the first generic adefovir dipivoxil on August 29, 2013. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists adefovir dipivoxil from 2 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2002 earliest approval on file
- 2013 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for adefovir dipivoxil (Hepsera)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $21.73 per Adefovir dipivoxil 10 mg tablet, down 12% from $24.71 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Adefovir dipivoxil 10 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Adefovir dipivoxil 10 mg tablet | Generic | $21.73 per tablet | $651.94 | -12% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the adefovir dipivoxil label say about other medicines?
The adefovir dipivoxil label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name adefovir dipivoxil. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cyclosporine | warnings and precautions | However, this is of special importance in patients at risk of or having underlying renal dysfunction and patients taking concomitant nephrotoxic agents such as cyclosporine, tacrolimus, aminoglycosides, vancomycin and non-steroidal anti-inflammatory drugs [See Adverse Reactions (6.2) and Clinical Pharmacology (12.3) ]. |
| Lamivudine | warnings and precautions | In order to reduce the risk of resistance in patients with lamivudine resistant HBV, adefovir dipivoxil should be used in combination with lamivudine and not as adefovir dipivoxil monotherapy. |
| Tacrolimus | warnings and precautions | However, this is of special importance in patients at risk of or having underlying renal dysfunction and patients taking concomitant nephrotoxic agents such as cyclosporine, tacrolimus, aminoglycosides, vancomycin and non-steroidal anti-inflammatory drugs [See Adverse Reactions (6.2) and Clinical Pharmacology (12.3) ]. |
| Tenofovir alafenamide | warnings and precautions | Adefovir dipivoxil should not be used concurrently with products containing tenofovir disoproxil fumarate or tenofovir alafenamide. |
| Tenofovir disoproxil | drug interactions | Adefovir dipivoxil should not be administered in combination with VIREAD [ See Warnings and Precautions (5.5)]. |
| Vancomycin | warnings and precautions | However, this is of special importance in patients at risk of or having underlying renal dysfunction and patients taking concomitant nephrotoxic agents such as cyclosporine, tacrolimus, aminoglycosides, vancomycin and non-steroidal anti-inflammatory drugs [See Adverse Reactions (6.2) and Clinical Pharmacology (12.3) ]. |
Source: FDA drug label (Adefovir dipivoxil), Apotex Corp., effective July 22, 2025 (SPL set 08e07fae-3191-b6a3-c894-d3a8cc53923f), via openFDA; the full label on DailyMed
What do FAERS reports show for adefovir dipivoxil?
The FDA Adverse Event Reporting System holds 1,270 reports that list adefovir dipivoxil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 68 are coded as a death and 389 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as adefovir dipivoxil?
4 other medicines are given the same way (oral) and in the same FDA class as adefovir dipivoxil or labeled mainly for the same use (hepatitis b), the same class first. Hepatitis B lists all 7 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Entecavir | Hepatitis B | 16 labelers | $0.219 per tablet 0.5 mg tablet | No current entry |
| Lamivudine | Hepatitis B | 14 labelers | $0.489 per tablet 150 mg tablet | No current entry |
| Tenofovir disoproxil | Hepatitis B | 15 labelers | $0.294 per tablet 300 mg tablet | No current entry |
| Tenofovir alafenamide | Hepatitis B | none listed | $51.98 per tablet 25 mg tablet | No current entry |
Every medicine labeled for the same conditions as adefovir dipivoxil
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to adefovir dipivoxil
- 4 medicines for the same use
- Other hepatitis b virus nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Adefovir dipivoxil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other