What the label lists and what reports show
Doravirine side effects
Doravirine's FDA label: “Most common adverse reactions (incidence greater than or equal to 5%, all grades) are nausea, dizziness, headache, fatigue, diarrhea, abdominal pain, and abnormal dreams.” FAERS holds 762 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 anxiety (71 reports).
- No generic listed
Check it at the source: the doravirine 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 PIFELTRO?PIFELTRO can cause serious side effects, including: Severe skin reactions have happened in people treated with PIFELTRO. Call your healthcare provider right away if you develop a rash during treatment with PIFELTRO. Stop taking PIFELTRO 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) Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicine. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine. […]
Source: FDA drug label, Merck Sharp & Dohme LLC, effective July 8, 2026 (SPL set 76ce1f00-28c0-4314-bd2c-d473fe3d0970), 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 nausea, dizziness, headache, fatigue, diarrhea, abdominal pain, 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 | PIFELTRO+2 NRTIs NRTI = nucleoside reverse transcriptase inhibitor. Once Daily N=383 | DRV+r+2 NRTIs Once Daily N=383 | DELSTRIGO Once Daily N=364 | EFV/FTC/TDF Once Daily N=364 |
|---|---|---|---|---|
| Nausea | 7% | 8% | 5% | 7% |
| Headache | 6% | 3% | 4% | 5% |
| Fatigue | 6% | 3% | 4% | 4% |
| Diarrhea | 6% | 13% | 4% | 6% |
| Abdominal Pain | 5% | 2% | 1% | 2% |
| Dizziness | 3% | 2% | 7% | 32% |
| Rash | 2% | 3% | 2% | 12% |
| Abnormal Dreams | 1% | <1% | 5% | 10% |
| Insomnia | 1% | 2% | 4% | 5% |
| Somnolence | 0% | <1% | 3% | 7% |
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) ] Immune Reconstitution Syndrome [see Warnings and Precautions (5.3) ] Most common adverse reactions (incidence greater than or equal to 5%, all grades) are nausea, dizziness, headache, fatigue, diarrhea, abdominal pain, 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 PIFELTRO used in combination with other antiretroviral agents is based on Week 96 data from two Phase 3, randomized, international, multicenter, double-blind, active-controlled trials (DRIVE-FORWARD (Protocol 018) and DRIVE-AHEAD (Protocol 021)). …
Source: FDA drug label, Merck Sharp & Dohme LLC, effective July 8, 2026 (SPL set 76ce1f00-28c0-4314-bd2c-d473fe3d0970), via openFDA; the full label on DailyMed
What do FAERS reports show?
762 reports list doravirine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 73 are coded as a death and 185 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, 3 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?
- Doravirine: 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