Quinine is an active pharmaceutical ingredient in the Methanolquinolines group (P01BC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised September 15, 2023[1]
1. Chloroquine-resistant malaria 2. 4)
How to take
GBOfficial regulatory label
CACanada· Health Canada
1 product
Side effects & warnings
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]
General Quinine sulphate is not approved for: • Treatment of severe or complicated P. falciparum malaria. • Prevention of malaria. • Treatment or prevention of nocturnal leg cramps. Use of Quinine-ODAN for Treatment or Prevention of Nocturnal Leg Cramps Quinine-ODAN 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. The risk associated with the use of Quinine-ODAN in the absence of evidence of its effectiveness for treatment or prevention of nocturnal leg cramps, outweighs any potential benefit in treating and/or preventing this benign, self-limiting condition [see Contraindications].
Drug interactions
Known interactions involving Quinine. Select one for details. This list is informational and not a complete interaction checker.
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Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PL334140099 · revised September 15, 2023
[2]Health Canada (DPD) · 00695459 · revised March 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Adults: In the treatment of chloroquine-resistant malaria – 600 mg of quinine salt 8-hourly for 7 days. Children: 10 mg of Quinine salt per kg bodyweight 8-hourly for 7 days.
Elderly:
As for adults 2.
For the treatment and prevention of nocturnal leg cramps:
Adults (including elderly): The recommended dose is 300mg at bedtime. A reduction in frequency of leg cramps may take up to 4 weeks to become apparent. Patients should be monitored closely during the early stages of treatment for adverse effects.
After an initial trial of 4 weeks, treatment should be stopped if there is no benefit. Treatment should be interrupted at approximately three monthly intervals to reassess the benefit of treatment.
Children:
Not recommended Route of administration: oral
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised September 15, 2023[1]
MedDRA system organ class Adverse Reaction Blood and lymphatic system disorders Thrombocytopenia, intravascular coagulation, hypoprothrombinaemia, haemoglobinuria, oliguria, haemolytic-uremic syndrome, pancytopenia, haemolysis, agranulocytosis, thrombocytopenic purpura Immune system disorders Generalised hypersensitivity reactions including angioneurotic oedema and fever Metabolism and nutrition disorders Hypoglycaemia Psychiatric disorders Agitation, confusion Nervous system disorders Headache, vertigo Eye disorders Blurred vision, defective colour perception, visual field constriction Ear and labyrinth disorders Tinnitus, impaired hearing Cardiac disorders Atrioventricular conduction disturbances, hypotension, prolongation of the QT interval, widening of the QRS complex and T wave flattening Respiratory, thoracic and mediastinal disorders Bronchospasm Gastrointestinal disorders Nausea, vomiting, diarrhoea, abdominal pain Skin and subcutaneous tissue disorders Flushing, rash, urticaria, eczematous dermatitis, oedema, erythema, lichen planus, pruritis, photosensitivity Musculoskeletal and connective tissue disorders Muscle weakness, aggravation of myasthenia gravis Renal and urinary disorders Renal insufficiency, acute renal failure
GBOfficial regulatory label· Warnings and precautions· revised September 15, 2023[1]
8), should be carefully considered relative to the potential benefits. These risks are likely to be of particular concern in the elderly. Quinine should only be considered when cramps are very painful or frequent, when other treatable causes of cramp have been ruled out, and when non-pharmacological measures have not worked.
6). Quinine may cause unpredictable serious and life-threatening thrombocytopenia, which is thought to be an idiosyncratic hypersensitivity reaction. Quinine should not be prescribed or administered to patients who have previously experienced any adverse reaction to quinine, including that in tonic water or other beverages.
Patients should be instructed to stop treatment and consult a physician if signs of thrombocytopenia such as unexplained bruising or bleeding occur. Quinine should be used with caution in patients with atrial fibrillation or other serious heart disease.
It may cause hypoprothrombinaemia. Patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency may develop acute haemolytic anaemia. Use with caution in patients with atrial fibrillation or other serious heart disease. Monitor treatment in all patients in case signs of resistance develop.
Administration of quinine may give rise to cinchonism, which is generally more severe in overdose, but may also occur in normal therapeutic doses. Patients should be warned not to exceed the prescribed dose, because of the possibility of serious, irreversible side effects in overdose.
Treatment for night cramps should be stopped if symptoms of cinchonism emerge. 9). Hypersensitivity to quinine may also occur with symptoms of cinchonism together with urticaria, flushing, pruritis, rash, fever, angioedema, dyspnoea and asthma.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised September 15, 2023[1]
Quinine is contra-indicated in patients with:
Hypersensitivity to quinine or to any of the excipient in the tablet Haemoglobinuria during malaria Tinnitus Myasthenia gravis Optic neuritis.
This is not medical advice. Consult a qualified healthcare professional.
Cardiovascular QT Prolongation and Ventricular Arrhythmias QT interval prolongation has been a consistent finding in studies which evaluated electrocardiographic changes with oral or parenteral quinine administration, regardless of age, clinical status, or severity of disease.
The maximum increase in QT interval has been shown to correspond with peak quinine plasma concentration. Quinine sulfate has been rarely associated with potentially fatal cardiac arrhythmias, including torsades de pointes, and ventricular fibrillation.
, amiodarone, sotalol, dofetilide). The use of macrolide antibiotics such as erythromycin should be avoided in patients receiving Quinine-ODAN. Fatal torsades de pointes was reported in an elderly patient who received concomitant quinine, erythromycin, and dopamine.
Although a causal Serious Warnings and Precautions Quinine-ODAN 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 use in the absence of evidence of its effectiveness in the treatment or prevention of nocturnal leg cramps outweighs any potential benefit (see WARNINGS - General).
3 of 10 relationship between a specific drug and the arrhythmia was not established in this case, erythromycin is a CYP3A4 inhibitor and could potentially increase quinine plasma levels when used concomitantly. , astemizole, cisapride, terfenadine, pimozide, halofantrine and quinidine.
Torsades de pointes has been reported in patients who received concomitant quinine and astemizole. Therefore, concurrent use of Quinine- ODAN with these medications, or drugs with similar properties, should be avoided [see Drug Interactions].
Concomitant administration of Quinine-ODAN with the antimalarial drugs, mefloquine or halofantrine, may result in electrocardiographic abnormalities, including QT prolongation, and increase the risk for torsades de pointes or other serious ventricular arrhythmias.
Quinine-ODAN should also be avoided in patients with known prolongation of QT interval and in patients with clinical conditions known to prolong the QT interval, such as uncorrected hypokalemia, bradycardia, and certain cardiac conditions [see Contraindications].
Atrial Fibrillation and Flutter Quinine-ODAN should be used with caution in patients with atrial fibrillation or atrial flutter. A paradoxical increase in ventricular response rate may occur with quinine, similar to that observed with quinidine.
If digoxin is used to prevent a rapid ventricular response, serum digoxin levels should be closely monitored, because digoxin levels may be increased with use of quinine [see Drug Interactions]. Hematologic Thrombocytopenia Quinine-induced thrombocytopenia is an immune-mediated disorder.
Severe cases of thrombocytopenia that are fatal or life threatening have been reported, including cases of HUS/TTP. Chronic renal impairment associated with the development of TTP has also been reported. Thrombocytopenia usually resolves within a week upon discontinuation of quinine.
If quinine is not stopped, a patient is at risk for fatal hemorrhage. Upon re-exposure to quinine from any source, a patient with quinine-dependent antibodies could develop thrombocytopenia that is more rapid in onset and more severe than the original episode.
Hepatic/Biliary/Pancreatic Hepatic Close monitoring is recommended for patients with impaired liver function, as this may result in increased exposure to quinine. Hypoglycemia Quinine stimulates release of insulin from the pancreas, and patients, especially pregnant women, may experience clinically significant hypoglycemia.
Immune Hypersensitivity Serious hypersensitivity reactions reported with quinine sulfate include anaphylactic shock, anaphylactoid reactions, urticaria, serious skin rashes, including Stevens-Johnson 4 of 10 syndrome and toxic epidermal necrolysis, angioedema, facial edema, bronchospasm, and pruritus.
A number of other serious adverse reactions reported with quinine, including thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS), thrombocytopenia, immune thrombocytopenic purpura (ITP), blackwater fever, disseminated intravascular coagulation, leukopenia, neutropenia, granulomatous hepatitis, and acute interstitial nephritis may also be due to hypersensitivity reactions.
Quinine-ODAN should be discontinued if there are any signs or symptoms of […]
This is not medical advice. Consult a qualified healthcare professional.