85/100 · Critical
Manufactured by Amneal Pharmaceuticals LLC
Quinine Adverse Events: High Seriousness and Diverse Reactions
17,762 FDA adverse event reports analyzed
Last updated: 2026-05-12
QUININE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. Based on analysis of 17,762 FDA adverse event reports, QUININE 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 include DRUG ABUSE, TOXICITY TO VARIOUS AGENTS, DYSPNOEA, NAUSEA, FALL. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for QUININE.
Quinine 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 17,762 adverse event reports for this medication, which is primarily manufactured by Amneal Pharmaceuticals Llc.
The most commonly reported adverse events include Drug Abuse, Toxicity To Various Agents, Dyspnoea. Of classified reports, 90.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Quinine reports show a high percentage of serious adverse events, including death and renal failure.
The most common reactions include dyspnea, nausea, and pain, indicating a broad range of potential side effects. Over 7,000 reports are serious, accounting for nearly 91% of all reports, highlighting the severity of adverse events. Drug interactions and overdose are also frequently reported, emphasizing the need for careful monitoring.
Patients taking Quinine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Quinine can interact with various drugs, including anticoagulants, and can cause severe reactions such as hypotension and renal failure. Overdose is particularly dangerous and can lead to life-threatening conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Quinine received a safety concern score of 85/100 (high concern). This is based on a 90.7% serious event ratio across 8,407 classified reports. The score accounts for 17,762 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: 4,439, Male: 3,243, Unknown: 20. The most frequently reported age groups are age 77 (250 reports), age 75 (219 reports), age 68 (189 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 8,407 classified reports for QUININE:
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 can interact with various drugs, including anticoagulants, and can cause severe reactions such as hypotension and renal failure. Overdose is particularly dangerous and can lead to life-threatening conditions.
If you are taking Quinine, here are important things to know. The most commonly reported side effects include drug abuse, toxicity to various agents, dyspnoea, nausea, fall. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Be cautious when using quinine, especially if you have pre-existing conditions or are taking other medications. Report any adverse reactions 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.
Regulatory oversight is stringent, with the FDA requiring detailed reporting of adverse events. Healthcare providers should monitor patients closely and avoid off-label use.
The FDA has received approximately 17,762 adverse event reports associated with Quinine. 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 include Drug Abuse, Toxicity To Various Agents, Dyspnoea, Nausea, Fall. By volume, the top reported reactions are: Drug Abuse (718 reports), Toxicity To Various Agents (482 reports), Dyspnoea (477 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.
Out of 8,407 classified reports, 7,626 (90.7%) were classified as serious and 781 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 break down by patient sex as follows: Female: 4,439, Male: 3,243, Unknown: 20. 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 adverse events are: age 77: 250 reports, age 75: 219 reports, age 68: 189 reports, age 74: 188 reports, age 69: 176 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 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 include: Pain, Diarrhoea, Vomiting, Dizziness, Muscle Spasms. 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 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 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 reports show a high percentage of serious adverse events, including death and renal failure.
Key safety signals identified in Quinine's adverse event data include: High percentage of serious adverse events (90.7%). Multiple organ systems affected, including respiratory, renal, and cardiovascular. Frequent reports of drug interactions and overdose. Significant number of reports involving death and renal failure. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Quinine can interact with various drugs, including anticoagulants, and can cause severe reactions such as hypotension and renal failure. Overdose is particularly dangerous and can lead to life-threatening conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Quinine.
Be cautious when using quinine, especially if you have pre-existing conditions or are taking other medications. Report any adverse reactions to your healthcare provider immediately.
Quinine has 17,762 adverse event reports on file with the FDA. The most common reactions include dyspnea, nausea, and pain, indicating a broad range of potential side effects. The volume of reports for Quinine reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is stringent, with the FDA requiring detailed reporting of adverse events. Healthcare providers should monitor patients closely and avoid off-label use. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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