What the label lists and what reports show
Doravirine and lamivudine and tenofovir disoproxil side effects
Doravirine and lamivudine and tenofovir disoproxil's FDA label: “Most common adverse reactions (incidence greater than or equal to 5%, all grades) are dizziness, nausea, and abnormal dreams.” FAERS holds 301 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 nausea (20 reports).
- No generic listed
- Boxed warning
Check it at the source: the doravirine and lamivudine and tenofovir disoproxil FDA label on DailyMed (effective July 8, 2026, Merck Sharp & Dohme LLC); 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 DELSTRIGO?DELSTRIGO may cause serious side effects, including: See " What is the most important information I should know about DELSTRIGO ?" Severe skin reactions have happened in people treated with DELSTRIGO. Call your healthcare provider right away if you develop a rash during treatment with DELSTRIGO. Stop taking DELSTRIGO and get medical help right away if you develop a painful rash with any of the following symptoms: fever blisters or peeling of the skin feeling tired or generally ill blisters or sores in the mouth swelling of the face or lymph nodes redness or swelling of the eyes (conjunctivitis) New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before you start and during treatment with DELSTRIGO. Your healthcare provider may tell you to stop taking DELSTRIGO if you develop new or worse kidney problems. […]
Source: FDA drug label, Merck Sharp & Dohme LLC, effective July 8, 2026 (SPL set cd1e9f84-607a-46d3-b01e-2736018d67b6), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence greater than or equal to 5%, all grades) are dizziness, nausea, and abnormal dreams.
Table 1: Adverse Reactions Frequencies of adverse reactions are based on all adverse events attributed to trial drugs by the investigator. (All Grades) Reported in ≥5% No adverse reactions of Grade 2 or higher (moderate…
| Reaction | DELSTRIGO Once Daily N=364 | EFV/FTC/TDF Once Daily N=364 |
|---|---|---|
| Dizziness | 7% | 32% |
| Nausea | 5% | 7% |
| Abnormal Dreams | 5% | 10% |
| Headache | 4% | 5% |
| Insomnia | 4% | 5% |
| Diarrhea | 4% | 6% |
| Somnolence | 3% | 7% |
| Rash Rash: includes rash, rash erythematous, rash generalized, rash macular, rash… | 2% | 12% |
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: Skin and Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Severe Acute Exacerbation of Hepatitis B in people with concomitant HIV-1 and HBV [see Warnings and Precautions (5.2) ] New Onset or Worsening Renal Impairment [see Warnings and Precautions (5.3) ] Bone Loss and Mineralization Defects [see Warnings and Precautions (5.5) ] Immune Reconstitution Syndrome [see Warnings and Precautions (5.6) ] Most common adverse reactions (incidence greater than or equal to 5%, all grades) are dizziness, nausea, and abnormal dreams. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or 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. Adverse Reactions in Adults with No Antiretroviral Treatment History The safety assessment of DELSTRIGO is based on Week 96 data from two Phase 3, randomized, international, multicenter, double-blind, active-controlled trials. …
Source: FDA drug label, Merck Sharp & Dohme LLC, effective July 8, 2026 (SPL set cd1e9f84-607a-46d3-b01e-2736018d67b6), via openFDA; the full label on DailyMed
What do FAERS reports show?
301 reports list doravirine and lamivudine and tenofovir disoproxil among the medicines taken, each a report of something that happened, not proof the medicine caused it; 24 are coded as a death and 68 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.
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?
- Doravirine and lamivudine and tenofovir disoproxil: 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