Quinine
/api/v1/drug/quinineBoxed warning
HEMATOLOGIC REACTIONS [see FULL PRESCRIBING INFORMATION for complete boxed warning] Quinine sulfate capsules use for the treatment or prevention of nocturnal leg cramps may result in serious and life-threatening hematologic reactions, including thrombocytopenia and hemolytic uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP). Chronic renal impairment associated with the development of TTP has been reported. The risk associated with quinine sulfate capsules use in the absence of evidence of its effectiveness in the treatment or prevention of nocturnal leg cramps outweighs any potential benefit ( 5.1 ) . WARNING: HEMATOLOGIC REACTIONS Quinine sulfate capsules use for the treatment or prevention of nocturnal leg cramps may result in serious and life-threatening hematologic reactions, including thrombocytopenia and hemolytic uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP). Chronic renal impairment associated with the development of TTP has been reported. The risk associated with quinine sulfate capsules use in the absence of evidence of its effectiveness in the treatment or prevention of nocturnal leg cramps outweighs any potential benefit [see WARNINGS AND PRECAUTIONS ( 5.1 )].
Mechanism of action
Sourced from openFDAMechanism-of-action class: Nucleic Acid Synthesis Inhibitors.
Indications
Sourced from openFDA- Quinine sulfate capsule USP is a cinchona alkaloid indicated for treatment of uncomplicated Plasmodium falciparum malaria ( 1 ). Quinine sulfate capsule USP is an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria.ICD-10: B54
Contraindications
Sourced from openFDA- Quinine sulfate is contraindicated in patients with the following: Prolongation of QT interval ( 4 ) Glucose-6-phosphate dehydrogenase (G6PD) deficiency ( 4 ) Myasthenia gravis ( 4 ) Known hypersensitivity to quinine, mefloquine, or quinidine ( 4 ) Optic neuritis ( 4 ) Quinine sulfate is contraindicated in patients with the following: • Prolonged QT interval. One case of a fatal ventricular arrhythmia was reported in an elderly patient with a prolonged QT interval at baseline, who received quinine sulfate intravenously for P.contraindicated
Dosage & administration
Sourced from openFDAAdults (≥ 16 years of age): 648 mg (two capsules) every 8 hours for 7 days ( 2.1 ). Patients with severe chronic renal impairment: one loading dose of 648 mg (two capsules) followed 12 hours later by 324 mg (one capsule) every 12 hours for 7 days ( 2.2 ). 2.1 Treatment of Uncomplicated P. falciparum Malaria For treatment of uncomplicated P. falciparum malaria in adults: Orally, 648 mg (two capsules) every 8 hours for 7 days [see CLINICAL STUDIES ( 14 )] . Quinine sulfate capsules USP should be taken with food to minimize gastric upset [see CLINICAL PHARMACOLOGY ( 12.3 )] . 2.2 Renal Impairment In patients with acute uncomplicated malaria and severe chronic renal impairment, the following dosage regimen is recommended: one loading dose of 648 mg quinine sulfate capsules USP followed 12 hours later by maintenance doses of 324 mg every 12 hours. The effects of mild and moderate renal impairment on the safety and pharmacokinetics of quinine sulfate are not known [see USE IN SPECIFIC POPULATIONS ( 8.6 ), CLINICAL PHARMACOLOGY ( 12.3 )] . 2.3 Hepatic Impairment Adjustment of the recommended dose is not required in mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment, but patients should be monitored closely for adverse effects of quinine. Quinine should not be administered in patients with severe (Child-Pugh C) hepatic impairment [see USE IN SPECIFIC POPULATIONS ( 8.7 ), CLINICAL PHARMACOLOGY ( 12.3 )] .
Warnings & precautions
Sourced from openFDANot indicated for the prevention or treatment of nocturnal leg cramps. Risk of serious and life-threatening adverse reactions ( 1 , 5.1 ). Thrombocytopenia, including ITP and HUS/TTP, has been reported. Discontinue drug ( 5.2 ). QT prolongation and ventricular arrhythmias. Avoid concomitant use with drugs known to prolong QT interval ( 5.3 ). Avoid concomitant use with rifampin. Quinine sulfate treatment failures have been reported ( 5.4 ). Avoid concomitant use with neuromuscular blocking agents. Quinine sulfate may potentiate neuromuscular blockade and cause respiratory depression ( 5.5 ). Serious and life threatening hypersensitivity reactions. Discontinue drug ( 4 , 5.6 ). Atrial fibrillation and flutter. Paradoxical increase in ventricular rate may occur. Closely monitor digoxin levels if used concomitantly ( 5.7 ). Hypoglycemia. Monitor for signs and symptoms ( 5.8 ). 5.1 Use of Quinine Sulfate for Treatment or Prevention of Nocturnal Leg Cramps Quinine sulfate may cause unpredictable serious and life-threatening hematologic reactions including thrombocytopenia and hemolytic-uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP) in addition to hypersensitivity reactions, QT prolongation, serious cardiac arrhythmias including torsades de pointes, and other serious adverse events requiring medical intervention and hospitalization. Chronic renal impairment associated with the development of TTP, and fatalities have also been reported.
Adverse reactions
Sourced from openFDAMost common adverse reactions are a cluster of symptoms called "cinchonism", which occurs to some degree in almost all patients taking quinine: headache, vasodilation and sweating, nausea, tinnitus, hearing impairment, vertigo or dizziness, blurred vision, disturbance in color perception, vomiting, diarrhea, abdominal pain, deafness, blindness, and disturbances in cardiac rhythm or conduction ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or www.lupinpharmaceuticals.com. or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Overall Quinine can adversely affect almost every body system. The most common adverse events associated with quinine use are a cluster of symptoms called "cinchonism", which occurs to some degree in almost all patients taking quinine. Symptoms of mild cinchonism include headache, vasodilation and sweating, nausea, tinnitus, hearing impairment, vertigo or dizziness, blurred vision, and disturbance in color perception. More severe symptoms of cinchonism are vomiting, diarrhea, abdominal pain, deafness, blindness, and disturbances in cardiac rhythm or conduction. Most symptoms of cinchonism are reversible and resolve with discontinuation of quinine. The following ADVERSE REACTIONS have been reported with quinine sulfate. Because these reactions have been reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Use in specific populations
Sourced from openFDARenal impairment: Reduce dose and dosing frequency for patients with severe chronic renal impairment ( 2.2 , 8.6 , 12.3 ). Hepatic impairment: Closely monitor for adverse events. Quinine should not be administered in patients with severe (Child-Pugh C) hepatic impairment ( 2.3 , 8.7 , 12.3 ). Pregnancy: Based on animal data may cause fetal harm. Use only if the potential benefit justifies the risk ( 8.1 ). Nursing Mothers: Exercise caution when administering to a nursing woman ( 8.3 ). 8.1 Pregnancy Pregnancy Category C There are extensive published data but few well-controlled studies of quinine sulfate in pregnant women. Published data on over 1,000 pregnancy exposures to quinine did not show an increase in teratogenic effects over the background rate in the general population; however, the majority of these exposures were not in the first trimester. In developmental and reproductive toxicity studies, central nervous system (CNS) and ear abnormalities and increased fetal deaths occurred in some species when pregnant animals received quinine at doses about 1 to 4 times the human clinical dose. Quinine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. P. falciparum malaria carries a higher risk of morbidity and mortality in pregnant women than in the general population. Pregnant women with P.
Overdosage
Sourced from openFDAQuinine overdose can be associated with serious complications, including visual impairment, hypoglycemia, cardiac arrhythmias, and death. Visual impairment can range from blurred vision and defective color perception, to visual field constriction and permanent blindness. Cinchonism occurs in virtually all patients with quinine overdose. Symptoms range from headache, nausea, vomiting, abdominal pain, diarrhea, tinnitus, vertigo, hearing impairment, sweating, flushing, and blurred vision, to deafness, blindness, serious cardiac arrhythmias, hypotension, and circulatory collapse. Central nervous system toxicity (drowsiness, disturbances of consciousness, ataxia, convulsions, respiratory depression and coma) has also been reported with quinine overdose, as well as pulmonary edema and adult respiratory distress syndrome. Most toxic reactions are dose-related; however, some reactions may be idiosyncratic because of the variable sensitivity of patients to the toxic effects of quinine. A lethal dose of quinine has not been clearly defined, but fatalities have been reported after the ingestion of 2 to 8 grams in adults. Quinine, like quinidine, has Class I antiarrhythmic properties.
Approval history
Sourced from openFDA- Sep 28, 2012ANDAANDA091661Teva Pharms
- Apr 24, 2015ANDAANDA203112Lupin
- Jul 15, 2015ANDAANDA203729Amneal Pharms
- Jul 22, 2015ANDAANDA204372Ingenus Pharms Llc
FAERS reports
- 1Drug Abuse7258.1%
- 2Dyspnoea4995.6%
- 3Toxicity To Various Agents4895.5%
- 4Nausea4755.3%
- 5Fall4675.2%
- 6Pain4605.1%
- 7Diarrhoea4064.5%
- 8Vomiting3794.2%
- 9Dizziness3634.1%
- 10Muscle Spasms3223.6%
- 11Fatigue3213.6%
- 12Headache3213.6%
- 13Hypotension3033.4%
- 14Drug Interaction3013.4%
- 15Drug Ineffective2853.2%
Literature
Recent PubMed references pinned to Quinine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Heparin-functionalized chitosan-poly(ε-caprolactone) nanoparticles loaded with quinine for selective targeting of infected erythrocytes and enhanced antiplasmodial efficacy.Nanomedicine (London, England) · 2026 · Amos Y, Ahmed R, Sauli E, et al.PMID 41979114DOI 10.1080/17435889.2026.2658589
- Quaternary biopesticides and disinfectants derived from quinine and amino acids - environmental prospects and risks.Journal of hazardous materials · 2026 · Rzemieniecki T, Juś K, Klejdysz T, et al.PMID 41581395DOI 10.1016/j.jhazmat.2026.141228
- Effects of Combined Intragastric Administration of Quinine with L-Leucine or L-Isoleucine on the Glycemic Response to, and Gastric Emptying of, a Mixed-Nutrient Drink in Healthy Males.The Journal of nutrition · 2026 · Sajjad M, Ghorbaninejad P, Bitarafan V, et al.PMID 41365468DOI 10.1016/j.tjnut.2025.101259
- The contrasting effects of two antimalarial drugs on insulin secretion.Cellular and molecular life sciences : CMLS · 2025 · Lu J, Xiong F, Zhang Q, et al.PMID 41288707DOI 10.1007/s00018-025-05933-0
- A Sensitive and Label-Free Ratiometric Fluorescent Aptasensor for Rapid Quinine Detection in Environmental and Food Samples.Chemistry, an Asian journal · 2025 · Bu L, Wei Y, Xu Y, et al.PMID 41116227DOI 10.1002/asia.70387
- Molecular basis of quinine-induced feeding suppression in Hyphantria cunea larvae.Pest management science · 2026 · Zhang W, Liu H, Sun J, et al.PMID 41058308DOI 10.1002/ps.70268
- Blending Carbohydrate and Quinine-Based Polymers Imparts Colloidal Stability, Improved Performance, and Cell Specificity for mRNA Delivery.Biomacromolecules · 2025 · Kreofsky NW, Roy P, Ghosh R, et al.PMID 40876700DOI 10.1021/acs.biomac.5c00901
- A J-aggregating cyanine-based NIR-II optical sensor for DNA aptamer-mediated detection and imaging of quinine.Chemical communications (Cambridge, England) · 2025 · Deng G, Zhang C, Chen J, et al.PMID 40827493DOI 10.1039/d5cc03180j
Clinical trials
The 10 most recently updated of 66 ClinicalTrials.gov registrations naming Quinine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Phase II Study of Dysplasix™ Intravaginal Suppositories in Patients Patients With High-Risk HPV and Mild Cervical Cytologic AbnormalitiesRecruiting · Phase 2 · Interventional · 45 enrolled · Amplexd Therapeutics, Inc.NCT07572396updated 2026-05-14
- Safety, Tolerability and Symptomatic Efficacy of the ROCK-Inhibitor Fasudil in Patients With Parkinson's DiseaseRecruiting · Phase 2 · Interventional · 75 enrolled · Technical University of MunichNCT05931575updated 2026-03-18
- Validation of Aspiration Markers in Intubated PatientsWithdrawn · Phase 1 · Interventional · 0 enrolled · Massachusetts General HospitalNCT02598713updated 2025-12-02
- Safety of Antimalarials in the FIRst trimEsterRecruiting · Phase 3 · Interventional · 1,510 enrolled · Liverpool School of Tropical MedicineNCT06962319updated 2025-11-19
- Omega-3, Nigella Sativa, Indian Costus, Quinine, Anise Seed, Deglycyrrhizinated Licorice, Artemisinin, Febrifugine on Immunity of Patients With (COVID-19)Completed · Phase 2 · Phase 3 · Interventional · 150 enrolled · Beni-Suef UniversityNCT04553705updated 2025-09-23
- Taste Physiology in Obese Volunteers Before and After Bariatric SurgeryRecruiting · Interventional · 16 enrolled · University Hospital, Basel, SwitzerlandNCT02902198updated 2025-04-03
- Effects of Intragastric Quinine, Alone or Combined With L-isoleucine, on Postprandial Glycaemic ControlCompleted · Interventional · 15 enrolled · University of AdelaideNCT05682339updated 2024-12-10
- Effects of Intragastric Quinine, Alone or Combined With L-leucine, on Postprandial Glycaemic ControlCompleted · Interventional · 15 enrolled · University of AdelaideNCT05720390updated 2024-12-10
- Effect of Quinine Hydrochloride in Overweight Population on Food Intake, Hunger and Gut Peptide ReleaseRecruiting · Phase 1 · Interventional · 40 enrolled · Universitaire Ziekenhuizen KU LeuvenNCT04873011updated 2024-07-03
- Efficacy of Only IV Artesunate Versus IV Artesunate Plus IV Quinine in the Treatment of Severe Malaria in Children: A Comparative StudyCompleted · Interventional · 104 enrolled · RESnTEC, Institute of ResearchNCT06472258updated 2024-06-26
Pharmacogenomics
CPIC-curated drug–gene pairs for Quinine. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.
- CYP2D6CPIC C (provisional)
- G6PDCPIC CFDA label: Actionable PGx
Frequently asked questions
- How does Quinine work?
- Mechanism-of-action class: Nucleic Acid Synthesis Inhibitors.
- What is Quinine used for?
- According to FDA labeling, Quinine carries indications including: Quinine sulfate capsule USP is a cinchona alkaloid indicated for treatment of uncomplicated Plasmodium falciparum malaria ( 1 ). Quinine sulfate capsule USP is an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Quinine?
- Quinine is classified as Methanolquinolines, Antimalarial, Nucleic Acid Synthesis Inhibitors, Carbohydrate Metabolism Alteration, Decreased DNA Replication, Decreased Metabolic Rate, Decreased Striated Muscle Organized Electrical Activity.
- What are the brand names for Quinine?
- Quinine is marketed under brand names including Qualaquin.
- What are the contraindications for Quinine?
- Quinine labeling lists contraindications including: Quinine sulfate is contraindicated in patients with the following: Prolongation of QT interval ( 4 ) Glucose-6-phosphate dehydrogenase (G6PD) deficiency ( 4 ) Myasthenia gravis ( 4 ) Known hypersensitivity to quinine, mefloquine, or quinidine ( 4 ) Optic neuritis ( 4 ) Quinine sulfate is contraindicated in patients with the following: • Prolonged QT interval. One case of a fatal ventricular arrhythmia was reported in an elderly patient with a prolonged QT interval at baseline, who received quinine sulfate intravenously for P.. Always consult the full prescribing information and a clinician.
quinine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.