What the label lists and what reports show
Ritonavir side effects
Ritonavir's FDA label: “The most frequently reported adverse drug reactions among patients receiving NORVIR alone or in combination with other antiretroviral drugs were gastrointestinal (including diarrhea, nausea, vomiting, abdominal pain (upper and lower), neurological …” FAERS holds 29,050 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 (1,622 reports).
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the ritonavir FDA label on DailyMed (effective July 23, 2026, AbbVie Inc.); 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 NORVIR?NORVIR can cause serious side effects including: See “ What is the most important information I should know about NORVIR? ” Liver problems. Some people taking NORVIR in combination with other antiviral medicines have developed liver problems which may be life-threatening. Your healthcare provider should do regular blood tests during your combination treatment with NORVIR. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems. Tell your healthcare provider right away if you get any of the following signs and symptoms of liver problems: ○ loss of appetite ○ pain or tenderness on your right side below your ribs ○ yellowing of your skin or whites of your eyes ○ itchy skin Inflammation of your pancreas (pancreatitis). […]
Source: FDA drug label, AbbVie Inc., effective July 23, 2026 (SPL set 2849298e-de6e-47bb-8194-56e075b33fc3), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most frequently reported adverse drug reactions among patients receiving NORVIR alone or in combination with other antiretroviral drugs were gastrointestinal (including diarrhea, nausea, vomiting, abdominal pain (upper and lower), neurological disturbances (including paresthesia and oral paresthesia), rash, and fatigue/asthenia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc.
Table 2. Percentage of Adult Patients, by Study and Treatment Group, with Chemistry and Hematology Abnormalities Occurring in greater than 3% of Patients Receiving NORVIR
| Limit | NORVIR plus ZDV | NORVIR | ZDV | NORVIR | Placebo | NORVIR plus Saquinavir |
|---|---|---|---|---|---|---|
| > 240 mg/dL | 30.7 | 44.8 | 9.3 | 36.5 | 8.0 | 65.2 |
| > 1000 IU/L | 9.6 | 12.1 | 11.0 | 9.1 | 6.3 | 9.9 |
| > 300 IU/L | 1.8 | 5.2 | 1.7 | 19.6 | 11.3 | 9.2 |
| > 180 IU/L | 5.3 | 9.5 | 2.5 | 6.4 | 7.0 | 7.8 |
| > 215 IU/L | 5.3 | 7.8 | 3.4 | 8.5 | 4.4 | 9.2 |
| > 800 mg/dL | 9.6 | 17.2 | 3.4 | 33.6 | 9.4 | 23.4 |
| > 1500 mg/dL | 1.8 | 2.6 | - | 12.6 | 0.4 | 11.3 |
| > 1500 mg/dL | 1.5 | 1.3 | - | 9.9 | 0.3 | - |
| < 8.0 g/dL | 0.9 | - | - | 3.8 | 3.9 | - |
| < 3.0 x 10 12 /L | 1.8 | - | 5.9 | 18.6 | 24.4 | - |
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 greater detail in other sections of the labeling. Drug Interactions [see Warnings and Precautions ( 5.1 ) ] Hepatotoxicity [see Warnings and Precautions ( 5.2 ) ] Pancreatitis [see Warnings and Precautions ( 5.3 ) ] Allergic Reactions/Hypersensitivity [see Warnings and Precautions ( 5.4 ) ] When co-administering NORVIR with other protease inhibitors, see the full prescribing information for that protease inhibitor including adverse reactions. The most frequently reported adverse drug reactions among patients receiving NORVIR alone or in combination with other antiretroviral drugs were gastrointestinal (including diarrhea, nausea, vomiting, abdominal pain (upper and lower), neurological disturbances (including paresthesia and oral paresthesia), rash, and fatigue/asthenia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reactions 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. …
Source: FDA drug label, AbbVie Inc., effective July 23, 2026 (SPL set 2849298e-de6e-47bb-8194-56e075b33fc3), via openFDA; the full label on DailyMed
What do FAERS reports show?
29,050 reports list ritonavir among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,638 are coded as a death and 9,659 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 19 reactions below, 5 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?
- Ritonavir: 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