72/100 · Elevated
Manufactured by Pfizer Laboratories Div Pfizer Inc
Tofacitinib Adverse Events: Pain and Fatigue Predominate, with Serious Reactions Notably High
696,662 FDA adverse event reports analyzed
Last updated: 2026-05-12
TOFACITINIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. Based on analysis of 696,662 FDA adverse event reports, TOFACITINIB has a safety score of 72 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 TOFACITINIB include DRUG INEFFECTIVE, PAIN, ARTHRALGIA, CONDITION AGGRAVATED, RHEUMATOID ARTHRITIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TOFACITINIB.
Tofacitinib has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 696,662 adverse event reports for this medication, which is primarily manufactured by Pfizer Laboratories Div Pfizer Inc.
The most commonly reported adverse events include Drug Ineffective, Pain, Arthralgia. Of classified reports, 47.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Pain and fatigue are the most common adverse reactions, with over 25,000 reports each.
Serious adverse events account for nearly half of all reports, indicating significant safety concerns. The reaction diversity is high, with over 100 distinct reactions reported.
Patients taking Tofacitinib should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Tofacitinib can cause serious infections and liver enzyme increases, and patients should be monitored for these conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Tofacitinib received a safety concern score of 72/100 (elevated concern). This is based on a 47.7% serious event ratio across 181,992 classified reports. The score accounts for 696,662 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 138,558, Male: 33,777, Unknown: 277. The most frequently reported age groups are age 63 (4,935 reports), age 61 (4,791 reports), age 60 (4,788 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 181,992 classified reports for TOFACITINIB:
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.
Tofacitinib can cause serious infections and liver enzyme increases, and patients should be monitored for these conditions.
If you are taking Tofacitinib, here are important things to know. The most commonly reported side effects include drug ineffective, pain, arthralgia, condition aggravated, rheumatoid arthritis. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening symptoms to their healthcare provider immediately. Regular monitoring of liver function and infection risk is recommended. 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 tofacitinib, and updates will be provided as necessary based on ongoing studies.
The FDA has received approximately 696,662 adverse event reports associated with Tofacitinib. 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 Tofacitinib include Drug Ineffective, Pain, Arthralgia, Condition Aggravated, Rheumatoid Arthritis. By volume, the top reported reactions are: Drug Ineffective (43,542 reports), Pain (25,737 reports), Arthralgia (19,670 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Tofacitinib.
Out of 181,992 classified reports, 86,746 (47.7%) were classified as serious and 95,246 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 Tofacitinib break down by patient sex as follows: Female: 138,558, Male: 33,777, Unknown: 277. 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 Tofacitinib adverse events are: age 63: 4,935 reports, age 61: 4,791 reports, age 60: 4,788 reports, age 65: 4,668 reports, age 59: 4,654 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 Tofacitinib 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 Tofacitinib include: Fatigue, Off Label Use, Joint Swelling, Headache, Rash. 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 Tofacitinib 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.
Tofacitinib has a safety concern score of 72 out of 100 (elevated 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. Pain and fatigue are the most common adverse reactions, with over 25,000 reports each.
Key safety signals identified in Tofacitinib's adverse event data include: Pain and arthralgia are the most frequently reported conditions, suggesting potential musculoskeletal issues.. Serious infections, including pneumonia and sepsis, are notable, with over 7,600 reports.. Liver enzyme increases and systemic lupus erythematosus are also significant safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Tofacitinib can cause serious infections and liver enzyme increases, and patients should be monitored for these conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Tofacitinib.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Regular monitoring of liver function and infection risk is recommended.
Tofacitinib has 696,662 adverse event reports on file with the FDA. Serious adverse events account for nearly half of all reports, indicating significant safety concerns. The volume of reports for Tofacitinib reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of tofacitinib, and updates will be provided as necessary based on ongoing studies. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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