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Quinine

ATC code P01BC01

Also known as: Chinin, Kinin

Key facts
Active substance
Quinine
Drug class
Antimalarial
ATC code
P01BC01
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

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 [see Indications and Usage (1) and Warnings and Precautions (5.1)].

Key facts

Quinine is an antimalarial. Per the US prescribing information, quinine sulfate capsules are indicated only for treatment of uncomplicated Plasmodium falciparum malaria.

What it is used for

  • Treatment of uncomplicated Plasmodium falciparum malaria, including regions with documented chloroquine resistance
  • Not approved for severe or complicated malaria, malaria prevention, or nocturnal leg cramps

Dosing

  • Adults: 648 mg (two capsules) orally every 8 hours for 7 days, with food
  • Severe chronic renal impairment: one loading dose of 648 mg, then 324 mg every 12 hours starting 12 hours later
  • Mild or moderate hepatic impairment (Child-Pugh A/B): no adjustment but monitor closely; severe (Child-Pugh C): do not administer

Contraindications

  • Prolonged QT interval
  • Known hypersensitivity reactions to quinine (e.g. thrombocytopenia, ITP, TTP, HUS, blackwater fever); hypersensitivity to mefloquine or quinidine
  • Myasthenia gravis; optic neuritis
  • For further contraindications see the full text

Important warnings

  • Boxed warning: use for nocturnal leg cramps may cause serious, life-threatening hematologic reactions (thrombocytopenia, HUS/TTP); the risk outweighs any benefit
  • Immune-mediated thrombocytopenia, including fatal cases; acute hemolytic anemia, including in G6PD deficiency
  • QT prolongation and ventricular arrhythmias; atrial fibrillation and flutter
  • Hypersensitivity reactions; hypoglycemia; caution with rifampin and neuromuscular blocking agents

Side effects

  • Most common is cinchonism in almost all patients: headache, sweating, nausea, tinnitus, hearing impairment, vertigo, blurred vision, disturbed color perception
  • Severe cinchonism: vomiting, diarrhea, abdominal pain, deafness, blindness, cardiac rhythm disturbances
  • Hematologic, among others agranulocytosis, thrombocytopenia, hemolytic anemia, HUS, TTP

Interactions

  • Aluminum- or magnesium-containing antacids: reduced absorption, avoid
  • CYP3A4 inducers (rifampin, carbamazepine, phenobarbital, phenytoin) lower and CYP3A4 inhibitors (ketoconazole, erythromycin, ritonavir) raise quinine levels
  • Quinine raises e.g. digoxin, desipramine and atorvastatin levels and potentiates neuromuscular blockers; warfarin: see the full text
  • Mefloquine: ECG abnormalities including QTc prolongation and increased seizure risk; avoid

Pregnancy and breastfeeding

  • Decades of experience have not identified a drug-associated risk of major birth defects or miscarriage
  • Present in human milk (less than 2 to 3 mg quinine base per day to the infant)

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Germany

  • Chinin OrifarmOrifarm Healthcare A/S · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Brand names in 6 more European countries
Cyprus
Quinine Sulphate Remedica
Denmark
Chininsulfate Axunio
France
Quinine Renaudin
Ireland
Quinine Sulphate Teva
Italy
Chinina Cloridrato Agenzia Industrie Difesa - Stabilimento Chimico Farmaceutico Militare, Chinina Cloridrato Galenica Senese, Chinina Solfato Nova Argentia
Netherlands
A-Qs

EMA – Article 57 product data (EU/EEA), 2026-10-29

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Sources

  1. U.S. Food and Drug Administration. QUININE SULFATE (Ingenus Pharmaceuticals, LLC) – Prescribing Information, 2024-09-16. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b2f73c64-b92c-49bf-ad39-e32ac83e4d3d
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. Wikidata (CC0): ATC P01BC.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.