What the label lists and what reports show
Adefovir dipivoxil side effects
Adefovir dipivoxil's FDA label: “Most common adverse reaction (incidence greater than 5%) in compensated liver disease patients were asthenia, headache, abdominal pain and nausea.” FAERS holds 1,270 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is drug resistance (275 reports).
- Generic listed
- Boxed warning
Check it at the source: the adefovir dipivoxil FDA label on DailyMed (effective July 22, 2025, Apotex Corp.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of adefovir dipivoxil tablets?Adefovir dipivoxil tablets can cause serious side effects. See “What is the most important information I should know about adefovir dipivoxil tablets?”) The most common side effects of adefovir dipivoxil tablets are weakness, headache, stomach pain, and nausea. These are not all the possible side effects of adefovir dipivoxil tablets. For more information, ask your doctor or pharmacist. Call your doctor for advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
Source: FDA drug label, Apotex Corp., effective July 22, 2025 (SPL set 08e07fae-3191-b6a3-c894-d3a8cc53923f), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reaction (incidence greater than 5%) in compensated liver disease patients were asthenia, headache, abdominal pain and nausea.
Table 2 Adverse Reactions (Grades 1 to 4) Reported in ≥3% of All Adefovir Dipivoxil-Treated Patients in Pooled Studies 437 to 438 Studies (0 to 48 Weeks) In these studies, the overall incidence of adverse reactions with…
| Adverse Reaction | Adefovir Dipivoxil 10 mg (N=294) | Placebo (N=228) |
|---|---|---|
| Asthenia | 13% | 14% |
| Headache | 9% | 10% |
| Abdominal Pain | 9% | 11% |
| Nausea | 5% | 8% |
| Flatulence | 4% | 4% |
| Diarrhea | 3% | 4% |
| Dyspepsia | 3% | 2% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in other sections of the labeling: Severe acute exacerbations of Hepatitis [ S ee Boxed Warning, Warnings and Precautions (5.1) ] Nephrotoxicity [See Boxed Warning, Warnings and Precautions (5.2) ] Most common adverse reaction (incidence greater than 5%) in compensated liver disease patients were asthenia, headache, abdominal pain and nausea. ( 6.1 ) The most common adverse reaction in pre- and post- transplantation lamivudine-resistant liver disease patients was increased creatinine. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of treatment with adefovir dipivoxil. Adverse reactions to adefovir dipivoxil identified from placebo-controlled and open label studies include the following: asthenia, headache, abdominal pain, diarrhea, nausea, dyspepsia, flatulence, increased creatinine, and hypophosphatemia.
Source: FDA drug label, 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?
1,270 reports list adefovir dipivoxil among the medicines taken, 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. Of the 21 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Adefovir dipivoxil: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions