35/100 · Moderate
Manufactured by Pfizer Laboratories Div Pfizer Inc
Nirmatrelvir and Ritonavir Adverse Events: Mostly Non-Serious, with Common Gastrointestinal Reactions
110,406 FDA adverse event reports analyzed
Last updated: 2026-05-12
NIRMATRELVIR AND RITONAVIR is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. Based on analysis of 110,406 FDA adverse event reports, NIRMATRELVIR AND RITONAVIR has a safety score of 35 out of 100. This lower score reflects a significant number of adverse event reports, suggesting that patients should discuss potential risks carefully with their healthcare provider. The most commonly reported adverse reactions for NIRMATRELVIR AND RITONAVIR include COVID-19, DISEASE RECURRENCE, DYSGEUSIA, DIARRHOEA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NIRMATRELVIR AND RITONAVIR.
Nirmatrelvir And Ritonavir has a safety concern score of 35 out of 100, placing it in the moderate concern category based on analysis of FDA adverse event data. The FDA has received approximately 110,406 adverse event reports for this medication, which is primarily manufactured by Pfizer Laboratories Div Pfizer Inc.
The most commonly reported adverse events include Covid-19, Disease Recurrence, Dysgeusia. Of classified reports, 17.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are non-serious, with gastrointestinal issues being the most common.
Disease recurrence and incorrect dose administration are significant safety concerns. Drug interactions and prescribing errors are reported but less frequent. Serious adverse events account for about 17.8% of total reports, with respiratory issues being notable. The adverse event profile is dominated by common symptoms like nausea, diarrhea, and fatigue.
Patients taking Nirmatrelvir And Ritonavir should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions and prescribing errors are common, with warnings to avoid certain medications and to follow the prescribed schedule strictly. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Nirmatrelvir And Ritonavir received a safety concern score of 35/100 (moderate concern). This is based on a 17.8% serious event ratio across 53,109 classified reports. The score accounts for 110,406 total adverse event reports and 100 distinct reaction types. This moderate score is typical for widely prescribed medications with established safety profiles.
Adverse event reports by sex: Female: 30,853, Male: 16,849, Unknown: 64. The most frequently reported age groups are age 68 (1,343 reports), age 70 (1,337 reports), age 69 (1,287 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 53,109 classified reports for NIRMATRELVIR AND 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.
Drug interactions and prescribing errors are common, with warnings to avoid certain medications and to follow the prescribed schedule strictly.
If you are taking Nirmatrelvir And Ritonavir, here are important things to know. The most commonly reported side effects include covid-19, disease recurrence, dysgeusia, diarrhoea, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow the prescribed dose and schedule strictly to avoid incorrect dose administration. Be cautious of potential drug interactions and consult a healthcare provider before combining with other medications. 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 continues to monitor the safety of Nirmatrelvir and Ritonavir, with ongoing reviews of adverse event reports.
The FDA has received approximately 110,406 adverse event reports associated with Nirmatrelvir And 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 Nirmatrelvir And Ritonavir include Covid-19, Disease Recurrence, Dysgeusia, Diarrhoea, Nausea. By volume, the top reported reactions are: Covid-19 (22,774 reports), Disease Recurrence (20,089 reports), Dysgeusia (7,316 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Nirmatrelvir And Ritonavir.
Out of 53,109 classified reports, 9,454 (17.8%) were classified as serious and 43,655 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 Nirmatrelvir And Ritonavir break down by patient sex as follows: Female: 30,853, Male: 16,849, Unknown: 64. 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 Nirmatrelvir And Ritonavir adverse events are: age 68: 1,343 reports, age 70: 1,337 reports, age 69: 1,287 reports, age 65: 1,269 reports, age 66: 1,266 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 Nirmatrelvir And Ritonavir adverse event reports is Pfizer Laboratories Div Pfizer 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 Nirmatrelvir And Ritonavir include: Headache, Cough, Fatigue, Incorrect Dose Administered, Vomiting. 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 Nirmatrelvir And 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.
Nirmatrelvir And Ritonavir has a safety concern score of 35 out of 100 (moderate 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. The majority of adverse events are non-serious, with gastrointestinal issues being the most common.
Key safety signals identified in Nirmatrelvir And Ritonavir's adverse event data include: High frequency of incorrect dose administration and product misuse.. Significant number of reports related to drug interactions and prescribing errors.. Respiratory symptoms like cough and dyspnea are notable among serious events.. Gastrointestinal issues are the most common adverse events, with diarrhea and nausea being frequent.. Serious adverse events include respiratory issues, kidney injury, and death.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions and prescribing errors are common, with warnings to avoid certain medications and to follow the prescribed schedule strictly. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Nirmatrelvir And Ritonavir.
Follow the prescribed dose and schedule strictly to avoid incorrect dose administration. Be cautious of potential drug interactions and consult a healthcare provider before combining with other medications.
Nirmatrelvir And Ritonavir has 110,406 adverse event reports on file with the FDA. Disease recurrence and incorrect dose administration are significant safety concerns. The volume of reports for Nirmatrelvir And Ritonavir reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Nirmatrelvir and Ritonavir, with ongoing reviews of adverse event reports. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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