Prescription medicine
Quinine First approved as Qualaquin
Quinine (Qualaquin) is a prescription medicine with an FDA approval on record since 2005. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $0.698 per quinine sulfate 324 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the quinine FDA label on DailyMed (effective November 9, 2023); the NDA 21799 record on Drugs@FDA; every quinine label on DailyMed.
Highlights of the record
FDA label of November 9, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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 )].
This box is printed on the prescription label of quinine; the over-the-counter label quoted on this page has none.
Used for
From the label: indications and usageFever with neck and back pain*
Forms and strengths
- 324 mg
Capsule.
On the market
- Earliest approval on file
- August 12, 2005 Qualaquin, Sun Pharm Industries; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first September 28, 2012; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 4 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.698 per capsule Quinine sulfate 324 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 8,527 through July 30, 2026
What is quinine used for?
From the label: indications and usageFever with neck and back pain*
FDA pharmacologic class: Antimalarial.
Source: FDA drug label (Chininum sulphuricum), Boiron, effective November 9, 2023 (SPL set 33885950-2a55-11e7-8288-424c58303031), via openFDA; the full label on DailyMed
What does the patient leaflet for quinine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about quinine sulfate capsules?Quinine sulfate capsules used to treat or prevent leg cramps may cause serious side effects or even death. Quinine sulfate capsules may cause your blood cell (platelet) count to drop causing serious bleeding problems. In some people, serious kidney problems can happen. Quinine sulfate capsules may cause problems with your heart rhythm that can lead to death. Quinine sulfate capsules may cause serious allergic reactions. Call your healthcare provider right away if you have: easy bruising severe nose bleed blood in urine or stool bleeding gums appearance of unusual purple, brown or red spots on your skin (bleeding under your skin) rash hives severe itching severe flushing swelling of your face trouble breathing chest pain rapid heartbeat irregular heart rhythm weakness sweating nervousness Taking quinine sulfate capsules with some other medicines can increase the chance of serious side effects. Tell your health care provider if you take any other medicines. Certain medicines can cause the blood levels of quinine sulfate to be too high or too low in your body. It is important for you to tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Quinine sulfate capsules and other medicines may affect each other causing serious side effects or death. Even medicines that you may take for a short period of time, such as antibiotics, can mix in your blood with quinine sulfate and cause serious side effects or death. Do not start taking a new medicine without telling your healthcare provider or pharmacist.
From the patient leaflet: How should I store quinine sulfate capsules?Keep the capsules in a tightly closed container. Do not refrigerate or freeze. Store at 15° to 30°C (59° to 86°F). Keep quinine sulfate capsules and all medicines out of the reach of children. General Information about quinine sulfate capsules Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use quinine sulfate capsules for a condition for which it was not prescribed. Do not give quinine sulfate capsules to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about quinine sulfate capsules. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about quinine sulfate capsules that is written for healthcare professionals. […]
Source: FDA drug label (QUININE SULFATE), Lupin Pharmaceuticals, Inc., effective October 31, 2025 (SPL set 1f32f05c-a215-40be-b951-e41a7b54a8a0), via openFDA; the full label on DailyMed
Is there a generic for quinine (Qualaquin)?
The FDA approved the first generic quinine on September 28, 2012. 5 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists quinine from 4 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2005 earliest approval on file
- 2012 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for quinine (Qualaquin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.698 per Quinine sulfate 324 mg capsule, down 3% from $0.722 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Quinine sulfate 324 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Quinine sulfate 324 mg capsule | Generic | $0.698 per capsule | $20.94 | -3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the quinine label say about other medicines?
The quinine label names 38 other medicines in its interaction, contraindication or warning sections. The labels of 25 other medicines name quinine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetazolamide | drug interactions (prescription label) | Urinary Alkalizers (Acetazolamide, Sodium Bicarbonate) Urinary alkalinizing agents may increase plasma quinine concentrations. |
| Aminophylline | drug interactions (prescription label) | Theophylline or Aminophylline In 20 healthy subjects who received multiple doses of quinine sulfate (648 mg every 8 hours x 7 days) with a single 300 mg oral dose of theophylline, the quinine mean C max and AUC were increased by 13% and 14% respectively. |
| Amiodarone | warnings and precautions (prescription label) | Quinine sulfate is not recommended for use with other drugs known to cause QT prolongation, including Class IA antiarrhythmic agents (e.g., quinidine, procainamide, disopyramide), and Class III antiarrhythmic agents (e.g., amiodarone, sotalol, dofetilide). |
| Atorvastatin | drug interactions (prescription label) | Quinine may increase plasma concentrations of atorvastatin, thereby increasing the risk of myopathy or rhabdomyolysis. |
| Carbamazepine | drug interactions (prescription label) | Antiepileptics (AEDs) (Carbamazepine, Phenobarbital, and Phenytoin) Carbamazepine, phenobarbital, and phenytoin are CYP3A4 inducers and may decrease quinine plasma concentrations if used concurrently with quinine sulfate. |
| Cholestyramine | drug interactions (prescription label) | Cholestyramine In 8 healthy subjects who received quinine sulfate 600 mg with or without 8 grams of cholestyramine resin, no significant difference in quinine pharmacokinetic parameters was seen. |
| Cimetidine | drug interactions (prescription label) | Histamine H 2 -Receptor Blockers [Cimetidine, Ranitidine (Nonspecific CYP450 Inhibitors)] In healthy subjects who were given a single oral 600 mg dose of quinine sulfate after pretreatment with cimetidine (200 mg three times daily and 400 mg at bedtime for 7 days) or ranitidine (150 mg twice daily for 7 days), the … |
| Desipramine | drug interactions (prescription label) | Desipramine (CYP2D6 Substrate) Quinine (750 mg/day for 2 days) decreased the metabolism of desipramine in patients who were extensive CYP2D6 metabolizers, but had no effect in patients who were poor CYP2D6 metabolizers. |
| Dextromethorphan | drug interactions (prescription label) | Lower doses (80 mg to 400 mg) of quinine did not significantly affect the pharmacokinetics of other CYP2D6 substrates, namely, debrisoquine, dextromethorphan, and methoxyphenamine. |
| Digoxin | drug interactions (prescription label) | Digoxin Increased digoxin plasma concentration ( 5.8 , 7.1 ). |
| Disopyramide | warnings and precautions (prescription label) | Quinine sulfate is not recommended for use with other drugs known to cause QT prolongation, including Class IA antiarrhythmic agents (e.g., quinidine, procainamide, disopyramide), and Class III antiarrhythmic agents (e.g., amiodarone, sotalol, dofetilide). |
| Dofetilide | warnings and precautions (prescription label) | Quinine sulfate is not recommended for use with other drugs known to cause QT prolongation, including Class IA antiarrhythmic agents (e.g., quinidine, procainamide, disopyramide), and Class III antiarrhythmic agents (e.g., amiodarone, sotalol, dofetilide). |
| Erythromycin | drug interactions (prescription label) | Macrolide Antibiotics (Erythromycin, Troleandomycin) (CYP3A4 Inhibitors) In a crossover study (N=10), healthy subjects who received a single oral 600 mg dose of quinine sulfate with the macrolide antibiotic, troleandomycin (500 mg every 8 hours) exhibited a 87% higher mean quinine AUC, a 45% lower mean oral clearance … |
| Flecainide | drug interactions (prescription label) | Although clinical drug interaction studies have not been performed, antimalarial doses (greater than or equal to 600 mg) of quinine may inhibit the metabolism of other drugs that are CYP2D6 substrates (e.g., flecainide, debrisoquine, dextromethorphan, metoprolol, paroxetine ). |
Every other medicine the quinine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Heparin | drug interactions (prescription label) | Quinine may also interfere with the anticoagulant effect of heparin. |
| Isoniazid | drug interactions (prescription label) | Isoniazid Isoniazid 300 mg/day pretreatment for 1 week did not significantly alter the pharmacokinetic parameter values of quinine. |
| Ketoconazole | drug interactions (prescription label) | Ketoconazole (CYP3A4 Inhibitor) In a crossover study, healthy subjects (N=9) who received a single oral dose of quinine hydrochloride (500 mg) concomitantly with ketoconazole (100 mg twice daily for … |
| Lovastatin | drug interactions (prescription label) | … inhibitors ("statins") that are CYP3A4 substrates (e.g., simvastatin, lovastatin) should carefully weigh the potential benefits and risks of each medication. |
| Mefloquine | contraindications (prescription label) | … 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: |
| Metoprolol | drug interactions (prescription label) | … CYP2D6 substrates (e.g., flecainide, debrisoquine, dextromethorphan, metoprolol, paroxetine ). |
| Midazolam | drug interactions (prescription label) | Midazolam (CYP3A4 Substrate) In 23 healthy subjects who received multiple doses of quinine sulfate capsules, 324 mg three times daily x 7 days with a single oral 2 mg dose of midazolam, the mean AUC … |
| Paroxetine | drug interactions (prescription label) | … substrates (e.g., flecainide, debrisoquine, dextromethorphan, metoprolol, paroxetine ). |
| Phenobarbital | drug interactions (prescription label) | Antiepileptics (AEDs) (Carbamazepine, Phenobarbital, and Phenytoin) Carbamazepine, phenobarbital, and phenytoin are CYP3A4 inducers and may decrease quinine plasma concentrations if used concurrently … |
| Phenytoin | drug interactions (prescription label) | Antiepileptics (AEDs) (Carbamazepine, Phenobarbital, and Phenytoin) Carbamazepine, phenobarbital, and phenytoin are CYP3A4 inducers and may decrease quinine plasma concentrations if used concurrently … |
| Pimozide | drug interactions (prescription label) | … prolongation potential (e.g., cisapride, terfenadine, halofantrine, pimozide and quinidine ) should also be avoided [see WARNINGS AND PRECAUTIONS ( 5.3 )]. |
| Procainamide | warnings and precautions (prescription label) | … prolongation, including Class IA antiarrhythmic agents (e.g., quinidine, procainamide, disopyramide), and Class III antiarrhythmic agents (e.g., amiodarone, sotalol, dofetilide). |
| Quinidine | contraindications (prescription label) | … Myasthenia gravis ( 4 ) Known hypersensitivity to quinine, mefloquine, or quinidine ( 4 ) Optic neuritis ( 4 ) Quinine sulfate is contraindicated in patients with the following: |
| Ranitidine | drug interactions (prescription label) | Histamine H 2 -Receptor Blockers [Cimetidine, Ranitidine (Nonspecific CYP450 Inhibitors)] In healthy subjects who were given a single oral 600 mg dose of quinine sulfate after pretreatment with … |
| Rifampin | drug interactions (prescription label) | Rifampin (CYP3A4 Inducer) In patients with uncomplicated P. falciparum malaria who received quinine sulfate 10 mg/kg concomitantly with rifampin 15 mg/kg/day for 7 days (N=29), the median AUC of … |
| Ritonavir | drug interactions (prescription label) | Ritonavir In healthy subjects who received a single oral 600 mg dose of quinine sulfate with the 15 th dose of ritonavir (200 mg every 12 hours for 9 days), there were 4-fold increases in the mean … |
| Simvastatin | drug interactions (prescription label) | … reductase inhibitors ("statins") that are CYP3A4 substrates (e.g., simvastatin, lovastatin) should carefully weigh the potential benefits and risks of each medication. |
| Sodium bicarbonate | drug interactions (prescription label) | Urinary Alkalizers (Acetazolamide, Sodium Bicarbonate) Urinary alkalinizing agents may increase plasma quinine concentrations. |
| Sotalol | warnings and precautions (prescription label) | … disopyramide), and Class III antiarrhythmic agents (e.g., amiodarone, sotalol, dofetilide). |
| Succinylcholine | drug interactions (prescription label) | Neuromuscular Blocking Agents (Pancuronium, Succinylcholine, Tubocurarine) In one report, quinine potentiated neuromuscular blockade in a patient who received pancuronium during an operative … |
| Tetracycline | drug interactions (prescription label) | Tetracycline In 8 patients with acute uncomplicated P. falciparum malaria who were treated with oral quinine sulfate (600 mg every 8 hours for 7 days) in combination with oral tetracycline (250 mg … |
| Theophylline | drug interactions (prescription label) | Theophylline or Aminophylline In 20 healthy subjects who received multiple doses of quinine sulfate (648 mg every 8 hours x 7 days) with a single 300 mg oral dose of theophylline, the quinine mean C … |
| Verapamil | warnings and precautions (prescription label) | … or patients receiving drugs known to prolong the PR interval (e.g. verapamil) or QRS interval (e.g. flecainide or quinidine) [see CLINICAL PHARMACOLOGY ( 12.2 )]. |
| Warfarin | drug interactions (prescription label) | Warfarin and oral anticoagulants Cinchona alkaloids, including quinine, may have the potential to depress hepatic enzyme synthesis of vitamin K-dependent coagulation pathway proteins and may enhance … |
Other labels that name quinine
Source: FDA drug label (Chininum sulphuricum), Boiron, effective November 9, 2023 (SPL set 33885950-2a55-11e7-8288-424c58303031), via openFDA; the full label on DailyMed
What do FAERS reports show for quinine?
The FDA Adverse Event Reporting System holds 8,527 reports that list quinine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,700 are coded as a death and 3,556 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other antimalarials
- the pharmacologic class, with prices and generics
- Quinine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other