What the label lists and what reports show
Darunavir side effects
Darunavir's FDA label: “The most common clinical adverse drug reactions to PREZISTA/ritonavir (incidence greater than or equal to 5%) of at least moderate intensity (greater than or equal to Grade 2) were diarrhea, nausea, rash, headache, abdominal pain and vomiting.” FAERS holds 15,039 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 pain (890 reports).
- Generic listed
Check it at the source: the darunavir FDA label on DailyMed (effective August 29, 2025, Janssen Products LP); 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 PREZISTA?PREZISTA may cause serious side effects, including: See " What is the most important information I should know about PREZISTA? " Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors including PREZISTA can get high blood sugar, develop diabetes, or your diabetes can get worse. Tell your healthcare provider if you notice an increase in thirst or urinate often while taking PREZISTA. Changes in body fat can happen in people who take HIV-1 medicine. The changes may include an increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known. Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicine. […]
Source: FDA drug label, Janssen Products LP, effective August 29, 2025 (SPL set 814301f9-c990-46a5-b481-2879a521a16f), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common clinical adverse drug reactions to PREZISTA/ritonavir (incidence greater than or equal to 5%) of at least moderate intensity (greater than or equal to Grade 2) were diarrhea, nausea, rash, headache, abdominal pain and vomiting.
Table 7: Grade 2 to 4 Laboratory Abnormalities Observed in Antiretroviral Treatment-Naïve HIV-1-Infected Adult Subjects Grade 4 data not applicable in Division of AIDS grading scale. (Trial TMC114-C211)
| Limit | PREZISTA/ritonavir 800/100 mg once daily + TDF/FTC | lopinavir/ritonavir 800/200 mg per day + TDF/FTC |
|---|---|---|
| >2.5 to ≤5.0 × ULN | 9% | 9% |
| >5.0 to ≤10.0 × ULN | 3% | 3% |
| >10.0 × ULN | <1% | 3% |
| >2.5 to ≤5.0 × ULN | 7% | 10% |
| >5.0 to ≤10.0 × ULN | 4% | 2% |
| >10.0 × ULN | 1% | 3% |
| >2.5 to ≤5.0 × ULN | 1% | 1% |
| >5.0 to ≤10.0 × ULN | 0% | <1% |
| >10.0 × ULN | 0% | 0% |
| >1.5 to ≤2.5 × ULN | <1% | 5% |
| >2.5 to ≤5.0 × ULN | <1% | <1% |
| >5.0 × ULN | 0% | 0% |
| 5.65–8.48 mmol/L 500–750 mg/dL | 3% | 10% |
| 8.49–13.56 mmol/L 751–1200 mg/dL | 2% | 5% |
| >13.56 mmol/L >1200 mg/dL | 1% | 1% |
| 6.20–7.77 mmol/L 240–300 mg/dL | 23% | 27% |
| >7.77 mmol/L >300 mg/dL | 1% | 5% |
| 4.13–4.90 mmol/L 160–190 mg/dL | 14% | 12% |
| ≥4.91 mmol/L ≥191 mg/dL | 9% | 6% |
| 6.95–13.88 mmol/L 126–250 mg/dL | 11% | 10% |
| 13.89–27.75 mmol/L 251–500 mg/dL | 1% | <1% |
| >27.75 mmol/L >500 mg/dL | 0% | 0% |
| >1.5 to ≤3.0 × ULN | 3% | 2% |
| >3.0 to ≤5.0 × ULN | <1% | 1% |
| >5.0 × ULN | 0% | <1% |
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 labeling: Hepatotoxicity [see Warnings and Precautions (5.2) ] Severe Skin Reactions [see Warnings and Precautions (5.3) ] Diabetes Mellitus/Hyperglycemia [see Warnings and Precautions (5.6) ] Fat Redistribution [see Warnings and Precautions (5.7) ] Immune Reconstitution Syndrome [see Warnings and Precautions (5.8) ] Hemophilia [see Warnings and Precautions (5.9) ] Due to the need for co-administration of PREZISTA with ritonavir, please refer to ritonavir prescribing information for ritonavir-associated adverse reactions. The most common clinical adverse drug reactions to PREZISTA/ritonavir (incidence greater than or equal to 5%) of at least moderate intensity (greater than or equal to Grade 2) were diarrhea, nausea, rash, headache, abdominal pain and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736) 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 clinical practice. …
Source: FDA drug label, Janssen Products LP, effective August 29, 2025 (SPL set 814301f9-c990-46a5-b481-2879a521a16f), via openFDA; the full label on DailyMed
What do FAERS reports show?
15,039 reports list darunavir among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,497 are coded as a death and 4,650 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 18 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?
- Darunavir: 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