85/100 · Critical
Manufactured by AbbVie Inc.
Ritonavir Adverse Events: High Seriousness and Diverse Reactions
53,209 FDA adverse event reports analyzed
Last updated: 2026-05-12
RITONAVIR is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AbbVie Inc.. Based on analysis of 53,209 FDA adverse event reports, RITONAVIR has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for RITONAVIR include DRUG INTERACTION, FOETAL EXPOSURE DURING PREGNANCY, ANXIETY, PAIN, EMOTIONAL DISTRESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for RITONAVIR.
Ritonavir has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 53,209 adverse event reports for this medication, which is primarily manufactured by Abbvie Inc..
The most commonly reported adverse events include Drug Interaction, Foetal Exposure During Pregnancy, Anxiety. Of classified reports, 91.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Ritonavir reports show a high percentage of serious adverse events, particularly related to renal and pregnancy complications.
The drug is associated with a wide range of reactions, including psychiatric, gastrointestinal, and renal issues. Pregnancy exposure is a significant concern, with multiple reports of spontaneous and induced abortions.
Patients taking Ritonavir should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ritonavir can cause significant drug interactions, particularly with other antiretrovirals, and should be used with caution. Warnings are issued for its use during pregnancy, as it can lead to spontaneous or induced abortions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ritonavir received a safety concern score of 85/100 (high concern). This is based on a 91.0% serious event ratio across 28,927 classified reports. The score accounts for 53,209 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 15,117, Female: 8,969, Unknown: 230. The most frequently reported age groups are age 50 (587 reports), age 52 (581 reports), age 43 (554 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 28,927 classified reports for RITONAVIR:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Ritonavir can cause significant drug interactions, particularly with other antiretrovirals, and should be used with caution. Warnings are issued for its use during pregnancy, as it can lead to spontaneous or induced abortions.
If you are taking Ritonavir, here are important things to know. The most commonly reported side effects include drug interaction, foetal exposure during pregnancy, anxiety, pain, emotional distress. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should inform their healthcare provider about any pre-existing conditions, especially renal or psychiatric issues. Pregnant women or those planning to become pregnant should discuss the risks and benefits with their healthcare provider before using Ritonavir. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA closely monitors Ritonavir's safety profile, and any new or severe adverse events should be reported promptly. Healthcare providers should be vigilant about monitoring patients for signs of renal and psychiatric issues.
The FDA has received approximately 53,209 adverse event reports associated with Ritonavir. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Ritonavir include Drug Interaction, Foetal Exposure During Pregnancy, Anxiety, Pain, Emotional Distress. By volume, the top reported reactions are: Drug Interaction (2,541 reports), Foetal Exposure During Pregnancy (2,374 reports), Anxiety (1,621 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ritonavir.
Out of 28,927 classified reports, 26,325 (91.0%) were classified as serious and 2,602 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Ritonavir break down by patient sex as follows: Male: 15,117, Female: 8,969, Unknown: 230. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Ritonavir adverse events are: age 50: 587 reports, age 52: 581 reports, age 43: 554 reports, age 54: 523 reports, age 53: 506 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Ritonavir adverse event reports is Abbvie Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Ritonavir include: Anhedonia, Maternal Exposure During Pregnancy, Nausea, Diarrhoea, Exposure During Pregnancy. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Ritonavir to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Ritonavir has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Ritonavir reports show a high percentage of serious adverse events, particularly related to renal and pregnancy complications.
Key safety signals identified in Ritonavir's adverse event data include: High percentage of serious adverse events (91%). Multiple pregnancy-related complications. Renal failure and impairment are common. Psychiatric issues like anxiety and depression are frequently reported. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ritonavir can cause significant drug interactions, particularly with other antiretrovirals, and should be used with caution. Warnings are issued for its use during pregnancy, as it can lead to spontaneous or induced abortions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ritonavir.
Patients should inform their healthcare provider about any pre-existing conditions, especially renal or psychiatric issues. Pregnant women or those planning to become pregnant should discuss the risks and benefits with their healthcare provider before using Ritonavir.
Ritonavir has 53,209 adverse event reports on file with the FDA. The drug is associated with a wide range of reactions, including psychiatric, gastrointestinal, and renal issues. The volume of reports for Ritonavir reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Ritonavir's safety profile, and any new or severe adverse events should be reported promptly. Healthcare providers should be vigilant about monitoring patients for signs of renal and psychiatric issues. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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