82/100 · Critical
Manufactured by Advanz Pharma (US) Corp.
Hydroxychloroquine Sulfate Adverse Events: High Serious Reaction Rate
558,480 FDA adverse event reports analyzed
Last updated: 2026-05-12
HYDROXYCHLOROQUINE SULFATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Advanz Pharma (US) Corp.. Based on analysis of 558,480 FDA adverse event reports, HYDROXYCHLOROQUINE SULFATE has a safety score of 82 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 SULFATE include DRUG INEFFECTIVE, RHEUMATOID ARTHRITIS, PAIN, FATIGUE, ARTHRALGIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for HYDROXYCHLOROQUINE SULFATE.
Hydroxychloroquine Sulfate has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 558,480 adverse event reports for this medication, which is primarily manufactured by Advanz Pharma (Us) Corp..
The most commonly reported adverse events include Drug Ineffective, Rheumatoid Arthritis, Pain. Of classified reports, 75.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (75.6%) among reported reactions.
A wide range of reactions, including serious conditions like liver injury and pericarditis. Significant report volume with over 558,000 total reports.
Patients taking Hydroxychloroquine Sulfate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Hydroxychloroquine sulfate can cause drug intolerance, rash, and gastrointestinal issues. It is contraindicated in patients with known hypersensitivity to the drug. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Hydroxychloroquine Sulfate received a safety concern score of 82/100 (high concern). This is based on a 75.6% serious event ratio across 88,479 classified reports. The score accounts for 558,480 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: 67,920, Male: 11,408, Unknown: 45. The most frequently reported age groups are age 44 (2,306 reports), age 43 (2,290 reports), age 59 (1,767 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 88,479 classified reports for HYDROXYCHLOROQUINE SULFATE:
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 sulfate can cause drug intolerance, rash, and gastrointestinal issues. It is contraindicated in patients with known hypersensitivity to the drug.
If you are taking Hydroxychloroquine Sulfate, here are important things to know. The most commonly reported side effects include drug ineffective, rheumatoid arthritis, pain, fatigue, arthralgia. 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. Follow prescribed dosing and do not use off-label without medical supervision. 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 sulfate, particularly for serious adverse events. Healthcare providers should be vigilant and consider alternative treatments for patients with a history of adverse reactions.
The FDA has received approximately 558,480 adverse event reports associated with Hydroxychloroquine Sulfate. 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 Sulfate include Drug Ineffective, Rheumatoid Arthritis, Pain, Fatigue, Arthralgia. By volume, the top reported reactions are: Drug Ineffective (28,942 reports), Rheumatoid Arthritis (20,168 reports), Pain (16,422 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 Sulfate.
Out of 88,479 classified reports, 66,855 (75.6%) were classified as serious and 21,624 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 Sulfate break down by patient sex as follows: Female: 67,920, Male: 11,408, Unknown: 45. 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 Sulfate adverse events are: age 44: 2,306 reports, age 43: 2,290 reports, age 59: 1,767 reports, age 60: 1,761 reports, age 63: 1,488 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 Sulfate adverse event reports is Advanz Pharma (Us) Corp.. 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 Sulfate include: Drug Intolerance, Joint Swelling, Off Label Use, Rash, Abdominal Discomfort. 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 Sulfate 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 Sulfate has a safety concern score of 82 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. High percentage of serious adverse events (75.6%) among reported reactions.
Key safety signals identified in Hydroxychloroquine Sulfate's adverse event data include: Liver injury reported in 2.1% of cases.. Pericarditis reported in 0.9% of cases.. Infection reported in 9.4% of cases.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Hydroxychloroquine sulfate can cause drug intolerance, rash, and gastrointestinal issues. It is contraindicated in patients with known hypersensitivity to the drug. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Hydroxychloroquine Sulfate.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosing and do not use off-label without medical supervision.
Hydroxychloroquine Sulfate has 558,480 adverse event reports on file with the FDA. A wide range of reactions, including serious conditions like liver injury and pericarditis. The volume of reports for Hydroxychloroquine Sulfate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of hydroxychloroquine sulfate, particularly for serious adverse events. Healthcare providers should be vigilant and consider alternative treatments for patients with a history of adverse reactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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