85/100 · Critical
Manufactured by Amneal Pharmaceuticals LLC
Quinine Sulfate Adverse Events: High Seriousness and Diverse Reactions
8,601 FDA adverse event reports analyzed
Last updated: 2026-05-12
QUININE SULFATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. Based on analysis of 8,601 FDA adverse event reports, QUININE SULFATE 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 QUININE SULFATE include NAUSEA, PAIN, DYSPNOEA, DIARRHOEA, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for QUININE SULFATE.
Quinine Sulfate 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 8,601 adverse event reports for this medication, which is primarily manufactured by Amneal Pharmaceuticals Llc.
The most commonly reported adverse events include Nausea, Pain, Dyspnoea. Of classified reports, 88.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Quinine Sulfate reports show a high percentage of serious adverse events, with renal failure and cardiovascular issues being common.
The drug is associated with a wide range of reactions, indicating potential for diverse side effects. Reports indicate a significant number of cases involving respiratory and gastrointestinal issues.
Patients taking Quinine Sulfate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Quinine Sulfate can interact with other drugs, leading to toxicity or reduced efficacy. Warnings include interactions with anticoagulants and other drugs affecting the cardiovascular system. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Quinine Sulfate received a safety concern score of 85/100 (high concern). This is based on a 88.7% serious event ratio across 3,487 classified reports. The score accounts for 8,601 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: 1,962, Male: 1,261, Unknown: 9. The most frequently reported age groups are age 75 (136 reports), age 79 (85 reports), age 69 (78 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 3,487 classified reports for QUININE 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.
Quinine Sulfate can interact with other drugs, leading to toxicity or reduced efficacy. Warnings include interactions with anticoagulants and other drugs affecting the cardiovascular system.
If you are taking Quinine Sulfate, here are important things to know. The most commonly reported side effects include nausea, pain, dyspnoea, diarrhoea, vomiting. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consumers should report any adverse reactions to the FDA's MedWatch program. Consult healthcare providers before using Quinine Sulfate, especially if taking 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 Quinine Sulfate due to its high rate of serious adverse events, particularly renal and cardiovascular issues.
The FDA has received approximately 8,601 adverse event reports associated with Quinine 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 Quinine Sulfate include Nausea, Pain, Dyspnoea, Diarrhoea, Vomiting. By volume, the top reported reactions are: Nausea (244 reports), Pain (219 reports), Dyspnoea (214 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Quinine Sulfate.
Out of 3,487 classified reports, 3,093 (88.7%) were classified as serious and 394 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 Quinine Sulfate break down by patient sex as follows: Female: 1,962, Male: 1,261, Unknown: 9. 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 Quinine Sulfate adverse events are: age 75: 136 reports, age 79: 85 reports, age 69: 78 reports, age 65: 77 reports, age 68: 75 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 Quinine Sulfate adverse event reports is Amneal Pharmaceuticals 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 Quinine Sulfate include: Dizziness, Renal Failure, Fall, Fatigue, Headache. 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 Quinine 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.
Quinine Sulfate 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. Quinine Sulfate reports show a high percentage of serious adverse events, with renal failure and cardiovascular issues being common.
Key safety signals identified in Quinine Sulfate's adverse event data include: Renal failure and acute kidney injury are key safety signals, with 172 and 121 reports respectively.. Cardiovascular issues, including myocardial infarction and atrial fibrillation, are also significant safety signals.. Drug interactions and ineffective drug performance are notable, with 104 and 126 reports respectively.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Quinine Sulfate can interact with other drugs, leading to toxicity or reduced efficacy. Warnings include interactions with anticoagulants and other drugs affecting the cardiovascular system. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Quinine Sulfate.
Consumers should report any adverse reactions to the FDA's MedWatch program. Consult healthcare providers before using Quinine Sulfate, especially if taking other medications.
Quinine Sulfate has 8,601 adverse event reports on file with the FDA. The drug is associated with a wide range of reactions, indicating potential for diverse side effects. The volume of reports for Quinine Sulfate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Quinine Sulfate due to its high rate of serious adverse events, particularly renal and cardiovascular issues. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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