What the label lists and what reports show
Lopinavir and ritonavir side effects
Lopinavir and ritonavir's FDA label: “Dysgeusia (22%), vomiting (21%), and diarrhea (12%) were the most common adverse reactions of any severity reported in pediatric patients treated with combination therapy for up to 48 weeks in Study 940.” FAERS holds 13,476 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 depression (1,136 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the lopinavir and 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 KALETRA?KALETRA can cause serious side effects, including: See “What is the most important information I should know about KALETRA?” Diabetes and high blood sugar (hyperglycemia). You may develop new or worsening diabetes or high blood sugar during treatment with KALETRA. Tell your healthcare provider if you get any of the following signs or symptoms: ○ urinate more often than usual ○ increased hunger or thirst ○ unusual weight loss ○ increase in your blood sugar levels Your healthcare provider may need to start you on medicine to treat high blood sugar or change your diabetes medicines. 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. […]
Source: FDA drug label, AbbVie Inc., effective July 23, 2026 (SPL set 8290add3-4449-4e58-6c97-8fe1eec972e3), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsDysgeusia (22%), vomiting (21%), and diarrhea (12%) were the most common adverse reactions of any severity reported in pediatric patients treated with combination therapy for up to 48 weeks in Study 940.
Table 10. Grade 3-4 Laboratory Abnormalities Reported in ≥ 2% of Adult Protease Inhibitor-Experienced Patients
| Limit 1 | KALETRA 400/100 mg Twice Daily + NVP + NRTIs (N = 148) | Investigator-Selected Protease Inhibitor(s) + NVP + NRTIs (N = 140) | Study 888 (48 Weeks) KALETRA Twice Daily + NNRTI + NRTIs (N = 127) | Study 957 2 and Study 765 3 (84-144 Weeks) KALETRA 800/200 mg Once Daily +NRTIs (N=300) | Study 802 (48 Weeks) KALETRA 400/100 mg Twice Daily +NRTIs (N=299) |
|---|---|---|---|---|---|
| >250 mg/dL | 1% | 2% | 5% | 2% | 2% |
| >3.48 mg/dL | 1% | 3% | 1% | 1% | 1% |
| >180 U/L | 5% | 11% | 8% | 3% | 2% |
| >215 U/L | 6% | 13% | 10% | 2% | 2% |
| >300 mg/dL | 20% | 21% | 39% | 6% | 7% |
| >750 mg/dL | 25% | 21% | 36% | 5% | 6% |
| >2 x ULN | 4% | 8% | 8% | 4% | 4% |
| <1.5 mg/dL | 1% | 0% | 2% | 1% | <1% |
| <0.75 x 10 9 /L | 1% | 2% | 4% | 3% | 4% |
| <80 g/L | 1% | 1% | 1% | 1% | 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 greater detail in other sections of the labeling. QT Interval Prolongation, PR Interval Prolongation [see Warnings and Precautions ( 5.5 , 5.6 )] Drug Interactions [see Warnings and Precautions ( 5.1 )] Pancreatitis [see Warnings and Precautions ( 5.3 )] Hepatotoxicity [see Warnings and Precautions ( 5.4 )] Commonly reported adverse reactions to KALETRA included diarrhea, nausea, vomiting, hypertriglyceridemia and hypercholesterolemia. ( 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 Trials 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 clinical practice. Adverse Reactions in Adults The safety of KALETRA has been investigated in about 2,600 patients in Phase II-IV clinical trials, of which about 700 have received a dose of 800/200 mg (6 capsules or 4 tablets) once daily. Along with nucleoside reverse transcriptase inhibitors (NRTIs), in some studies, KALETRA was used in combination with efavirenz or nevirapine. …
Source: FDA drug label, AbbVie Inc., effective July 23, 2026 (SPL set 8290add3-4449-4e58-6c97-8fe1eec972e3), via openFDA; the full label on DailyMed
What do FAERS reports show?
13,476 reports list lopinavir and ritonavir among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,776 are coded as a death and 5,005 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. Reports rose sharply in 2020 (1,446, against a median of 312 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 20 reactions below, 10 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?
- Lopinavir and 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