85/100 · Critical
Manufactured by Chartwell RX, LLC
Hydroxychloroquine Adverse Events Show High Seriousness and Reaction Diversity
427,335 FDA adverse event reports analyzed
Last updated: 2026-05-12
HYDROXYCHLOROQUINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Chartwell RX, LLC. Based on analysis of 427,335 FDA adverse event reports, HYDROXYCHLOROQUINE 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 HYDROXYCHLOROQUINE include DRUG INEFFECTIVE, OFF LABEL USE, RHEUMATOID ARTHRITIS, PAIN, ARTHRALGIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for HYDROXYCHLOROQUINE.
Hydroxychloroquine 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 427,335 adverse event reports for this medication, which is primarily manufactured by Chartwell Rx, Llc.
The most commonly reported adverse events include Drug Ineffective, Off Label Use, Rheumatoid Arthritis. Of classified reports, 84.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Hydroxychloroquine reports show a high percentage of serious adverse events (84.7%).
A wide variety of reactions are reported, indicating diverse safety concerns. Fatigue, rash, and nausea are among the most frequently reported symptoms.
Patients taking Hydroxychloroquine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Hydroxychloroquine can cause serious liver injury and heart issues, and should be used with caution, especially in patients with pre-existing conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Hydroxychloroquine received a safety concern score of 85/100 (high concern). This is based on a 84.7% serious event ratio across 71,887 classified reports. The score accounts for 427,335 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: Female: 48,696, Male: 13,465, Unknown: 50. The most frequently reported age groups are age 44 (1,985 reports), age 43 (1,956 reports), age 60 (1,448 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 71,887 classified reports for HYDROXYCHLOROQUINE:
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.
Hydroxychloroquine can cause serious liver injury and heart issues, and should be used with caution, especially in patients with pre-existing conditions.
If you are taking Hydroxychloroquine, here are important things to know. The most commonly reported side effects include drug ineffective, off label use, rheumatoid arthritis, pain, arthralgia. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult a healthcare provider before starting hydroxychloroquine, especially if you have pre-existing conditions like liver or heart disease. Report any unusual symptoms to your healthcare provider immediately. 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 hydroxychloroquine, particularly in relation to its use for unapproved indications and during pregnancy.
The FDA has received approximately 427,335 adverse event reports associated with Hydroxychloroquine. 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 Hydroxychloroquine include Drug Ineffective, Off Label Use, Rheumatoid Arthritis, Pain, Arthralgia. By volume, the top reported reactions are: Drug Ineffective (20,457 reports), Off Label Use (15,128 reports), Rheumatoid Arthritis (12,921 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Hydroxychloroquine.
Out of 71,887 classified reports, 60,898 (84.7%) were classified as serious and 10,989 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 Hydroxychloroquine break down by patient sex as follows: Female: 48,696, Male: 13,465, Unknown: 50. 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 Hydroxychloroquine adverse events are: age 44: 1,985 reports, age 43: 1,956 reports, age 60: 1,448 reports, age 58: 1,271 reports, age 59: 1,242 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 Hydroxychloroquine adverse event reports is Chartwell Rx, Llc. 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 Hydroxychloroquine include: Drug Intolerance, Fatigue, Joint Swelling, Rash, Condition Aggravated. 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 Hydroxychloroquine 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.
Hydroxychloroquine 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. Hydroxychloroquine reports show a high percentage of serious adverse events (84.7%).
Key safety signals identified in Hydroxychloroquine's adverse event data include: High percentage of serious adverse events (60,898 out of 71,887, 84.7%).. Diverse reactions reported, including liver injury, heart issues, and gastrointestinal problems.. Significant number of reports involving rheumatoid arthritis and related conditions.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Hydroxychloroquine can cause serious liver injury and heart issues, and should be used with caution, especially in patients with pre-existing conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Hydroxychloroquine.
Consult a healthcare provider before starting hydroxychloroquine, especially if you have pre-existing conditions like liver or heart disease. Report any unusual symptoms to your healthcare provider immediately.
Hydroxychloroquine has 427,335 adverse event reports on file with the FDA. A wide variety of reactions are reported, indicating diverse safety concerns. The volume of reports for Hydroxychloroquine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of hydroxychloroquine, particularly in relation to its use for unapproved indications and during pregnancy. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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