FDA-filed SPL labeling · retrieved through openFDA

Chloroquine

Chloroquine is an antimalarial and antiprotozoal medicine used to treat and prevent certain types of malaria and to treat extraintestinal amebiasis (an amoeba infection that has spread beyond the gut).

Brand name Aralen
Drug class Antimalarial
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 6 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveNov 7, 2025
Clinical labels in scope 6
AvailabilityRx
Earliest approval/marketing year 1949
FDA-listed product records 29
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 17, 2026
Chloroquine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Chloroquine Phosphate tablets are an established treatment and prevention option for certain types of malaria, and a treatment for extraintestinal amebiasis, but they carry real risks — especially to the heart and eyes — that require careful prescriber oversight. Resistance is widespread in some regions, so always confirm with your doctor or the CDC that chloroquine is appropriate for your destination or infection. Never adjust your dose on your own, store the tablets securely away from children, and report any new vision changes, heart symptoms, or mood changes to your doctor immediately.

📖 Chloroquine: Patient Information Guide

A plain-language walkthrough of Chloroquine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Chloroquine Phosphate tablets are approved for the following uses:

  • Treatment of uncomplicated malaria — caused by susceptible strains of Plasmodium falciparum, P. malariae, P. ovale, and P. vivax.
  • Prevention (prophylaxis) of malaria — only in geographic areas where chloroquine resistance has not been reported.
  • Extraintestinal amebiasis — infection with Entamoeba histolytica that has spread outside the intestines.
  • Not for complicated malaria (such as cerebral malaria or malaria causing kidney failure).
  • Not effective against the dormant liver-stage forms of P. vivax and P. ovale — an additional medicine (an 8-aminoquinoline) is needed to prevent relapses from those species.
⚙️How it works

Chloroquine is a 4-aminoquinoline — a type of antiprotozoal (anti-parasite) drug. It is thought to work by concentrating inside the malaria parasite's acid compartments and blocking the parasite's ability to neutralize a toxic byproduct of digesting hemoglobin, the oxygen-carrying protein in red blood cells. It may also interfere with parasite enzymes by interacting with DNA. The net result is that the parasite cannot survive inside red blood cells. It is also active against the trophozoite (feeding/active) stage of Entamoeba histolytica, which causes amebiasis.

Chloroquine only works against the blood-stage forms of the malaria parasite — not the gametocytes (the form that mosquitoes pick up) or the dormant liver-stage forms called hypnozoites in P. vivax and P. ovale. Resistance is widespread in P. falciparum worldwide and has been reported in P. vivax; parasites resistant to hydroxychloroquine also tend to be resistant to chloroquine.

💊How it's taken

Chloroquine Phosphate tablets are taken by mouth. The timing and number of doses depend on why you are taking it:

  • Prevention: taken once a week, on exactly the same day each week — ideally starting two weeks before travel and continued for eight weeks after leaving the area.
  • Treatment of malaria: doses are spread over three days, with the first (larger) dose followed by smaller doses at set intervals; children's doses are based on body weight.
  • Extraintestinal amebiasis: taken daily over several weeks, usually combined with a separate medicine that targets the intestines.

Always follow your prescriber's exact directions. Do not stop early or adjust the dose on your own, and ask your pharmacist if you miss a dose.

🤒Side effects — in detail

Like any medicine, chloroquine can cause side effects. The most commonly reported ones include:

  • Nausea, vomiting, stomach cramps, or diarrhea
  • Loss of appetite
  • Headache
  • Blurred vision or difficulty focusing
  • Itching or skin rash
  • Dizziness

More serious reactions — including irreversible retinal (eye) damage, dangerous heart rhythm changes, severe low blood sugar, muscle weakness, liver injury, and neuropsychiatric effects such as depression or suicidal thoughts — require prompt medical attention. Contact your doctor or seek emergency care right away if any of these develop.

⚠️Warnings & precautions
  • Eye/retinal damage: Irreversible damage to the retina (the light-sensing layer at the back of the eye) can occur, especially with long-term or high-dose use. A baseline eye exam is required within the first year of starting therapy, with follow-up exams as directed. Report any vision changes immediately.
  • Heart risks: Chloroquine can cause life-threatening heart rhythm problems (including QT prolongation and torsades de pointes) and cardiomyopathy (heart muscle damage). Risk is higher at high doses, with certain other drugs, and in people with existing heart conditions or low potassium/magnesium. Fatal cases have been reported.
  • Severe low blood sugar (hypoglycemia): Chloroquine can cause dangerously low blood sugar, even in people not taking diabetes medicines. Watch for sweating, shaking, confusion, or loss of consciousness.
  • Neuropsychiatric effects: Depression, suicidal thoughts, hallucinations, and other mental health changes have been reported, typically within the first month. Contact your doctor right away if these occur.
  • Muscle and nerve toxicity: Progressive weakness of the upper arms and legs and abnormal nerve function have been reported with long-term use. Periodic monitoring is needed.
  • Chloroquine resistance: Resistance is widespread in P. falciparum and reported in P. vivax. Always confirm suitability for the region with your prescriber or the CDC before use.
  • Danger to children: Accidental ingestion of even a small amount can be fatal in children. Store securely out of their reach at all times.
  • Psoriasis and porphyria: Chloroquine can trigger severe psoriasis flares and can worsen porphyria; serious liver injury has been reported in people with porphyria cutanea tarda.
🔀What it interacts with

Chloroquine can interact with several medicines and supplements — tell your prescriber and pharmacist everything you take:

  • Antacids and kaolin — reduce chloroquine absorption; take at least 4 hours apart.
  • Cimetidine (a heartburn medicine) — slows chloroquine breakdown, raising blood levels; avoid combining.
  • Insulin and diabetes medicines — chloroquine can amplify blood-sugar-lowering effects, raising the risk of hypoglycemia.
  • Amiodarone and moxifloxacin — both can affect heart rhythm; combining with chloroquine increases the risk of dangerous arrhythmias.
  • Ampicillin — chloroquine reduces how much of this antibiotic the body absorbs; separate doses by at least 2 hours.
  • Cyclosporine — chloroquine can cause cyclosporine blood levels to rise sharply; close monitoring required.
  • Mefloquine (another antimalarial) — increases seizure risk when combined with chloroquine.
  • Tamoxifen — both drugs can damage the retina; this combination is not recommended.
  • Praziquantel — chloroquine can reduce how much praziquantel the body absorbs.
  • Rabies vaccine (intradermal human diploid-cell) — chloroquine at prophylactic doses can reduce the immune response to this vaccine.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Known allergy to chloroquine or related 4-aminoquinoline medicines — do not take it.
  • Existing retinal or visual field problems — chloroquine is contraindicated for uses other than acute malaria if such changes are already present.
  • Heart disease, irregular heartbeat, or low potassium/magnesium — increased risk of serious heart problems; tell your prescriber.
  • Psoriasis — chloroquine can trigger a severe flare; use only if benefits clearly outweigh risks.
  • Porphyria — chloroquine can worsen this condition and cause serious liver injury; avoid if possible.
  • Diabetes or blood-sugar-lowering medicines — chloroquine can cause severe low blood sugar; monitoring may be needed.
  • Kidney problems — can affect chloroquine clearance and increase risk of retinal damage.
  • Pregnancy — animal studies showed fetal harm at high doses; human data at recommended doses have not shown increased birth defects, but discuss the individual benefit-risk balance with your prescriber.
  • Children — doses must be calculated by body weight and must never exceed adult doses; keep tablets completely out of reach, as even a small overdose can be fatal.
  • Older adults — follow prescriber guidance, as the label notes special geriatric precautions.
🚑If you take too much

Chloroquine is absorbed very quickly, and a toxic amount can cause symptoms within minutes — including nausea, vomiting, headache, vision disturbances, seizures, dangerously low potassium, and severe heart rhythm problems that can lead to cardiac arrest. Even a relatively small amount can be fatal in young children. If you suspect an overdose, call emergency services immediately — this is a life-threatening emergency that requires urgent medical treatment including heart and breathing support.

📡Pharmacodynamics — effects in the body

Chloroquine acts against the blood-stage (erythrocytic) forms of susceptible Plasmodium species and against the active (trophozoite) stage of Entamoeba histolytica. It does not act against gametocytes or the dormant liver-stage (hypnozoite) forms of P. vivax and P. ovale. At the heart level, chloroquine can prolong the QT interval (a measure of heart electrical activity), which at higher doses raises the risk of serious arrhythmias. It has also been associated with phospholipidosis — an abnormal buildup of phospholipids in tissues — which underlies some of its toxicities in the heart, muscles, nerves, and kidneys.

🔬Pharmacokinetics — how your body processes it

Chloroquine is rapidly and almost completely absorbed from the gastrointestinal tract after oral dosing. About 55% of the drug in the bloodstream is bound to plasma proteins. It is widely distributed into body tissues — concentrating especially in the liver, spleen, kidney, and lungs — and is cleared from the body very slowly, meaning it stays in the system for a long time after the last dose. It is broken down (metabolized) in the body, with the main breakdown product being desethylchloroquine, and is primarily eliminated through the urine; urine acidification speeds up its excretion.

📦How to store it

Dispense in tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)

📄 Written from Chloroquine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

29

Supplements & herbs that interact with Chloroquine

29 supplements and herbal products have documented interactions with Chloroquine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 2
  • Moderate · 18
  • Minor · 9
Every supplement checked against Chloroquine — ranked by severity The full interaction hub: 2 major · 18 moderate · 9 minor · every one linked to its full report. Check Chloroquine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Chloroquine — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is chloroquine used for?
Chloroquine Phosphate tablets are used mainly for malaria — either to treat an active infection caused by susceptible strains or to prevent it when you're traveling to a region where the parasite is still sensitive to this drug. They're also approved to treat extraintestinal amebiasis, which is an amoeba infection that has spread outside the intestines (for example, to the liver). Keep in mind it does NOT work in areas where malaria parasites have developed resistance to it, and it won't prevent relapses from certain malaria types without an additional medicine.
How do I take this tablet — is there a specific time of day or should I take it with food?
Follow the schedule your prescriber gave you exactly, because the timing really matters for chloroquine to work properly. For prevention, you take it once a week on the exact same day every week. For treatment, you take doses spread over three days at set intervals. The label doesn't specify that food is required, but if the tablet upsets your stomach, taking it with a meal or a glass of milk can help. Never double up if you miss a dose without first checking with your pharmacist or doctor.
What side effects should I watch out for, and which ones need a doctor's call?
Nausea, stomach cramps, headache, itching, and mild blurred vision are among the more common side effects — annoying but usually manageable. The ones to call your doctor about right away are any significant vision changes or blind spots (which can signal permanent eye damage), a racing or irregular heartbeat, shakiness or confusion that could mean low blood sugar, and any new feelings of depression or thoughts of self-harm. These more serious effects are less common but genuinely important to catch early.
I've heard chloroquine can hurt your eyes. How worried should I be?
It's a real concern worth taking seriously, especially with long-term use or higher doses. Chloroquine can cause irreversible damage to the retina — the light-sensitive tissue at the back of your eye — which can affect your vision permanently. Your prescriber should arrange a baseline eye exam within your first year on the medication, and follow-up exams after that. The key is catching any early changes before they become permanent. Report any vision changes — blurring, blind spots, difficulty reading — to your doctor immediately rather than waiting for your next scheduled appointment.
Is it safe to take during pregnancy?
Human studies at the doses used for malaria prevention and treatment have not shown an increased risk of birth defects, but animal studies at much higher doses did show fetal harm. That means your prescriber needs to weigh the benefit — protecting you from a serious malaria infection — against any potential risk to the baby. Don't stop or start chloroquine during pregnancy without talking to your doctor first, since untreated malaria during pregnancy carries its own serious risks.
Are there any common medicines I should avoid while taking chloroquine?
Yes — a few important ones. Antacids can block chloroquine from being properly absorbed, so space them at least four hours apart. Cimetidine (a heartburn medicine) can raise chloroquine levels in your blood, so it's best avoided. Some heart medicines and certain antibiotics like moxifloxacin can add to chloroquine's effect on your heart rhythm, which is risky. And tamoxifen, used in breast cancer treatment, can increase the risk of eye damage when combined with chloroquine. Always give your pharmacist or prescriber a full list of everything you take, including supplements.
Is Chloroquine available over the counter?
Chloroquine is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Chloroquine first available?
Chloroquine has been available in the United States since at least 1949, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Chloroquine?
Chloroquine is supplied by 12 manufacturers listed in the FDA NDC Directory, including Amneal Pharmaceuticals of New York LLC, Rising Pharma Holdings, Inc., Suven Pharmaceuticals Limited.

💬 Answers drafted from Chloroquine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Chloroquine comes

Chloroquine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
How this form is used
What it may be used for
  • Chloroquine Phosphate tablets are used to treat uncomplicated malaria caused by susceptible strains of P. falciparum, P. malariae, P. ovale, and P. vivax.
  • Chloroquine Phosphate tablets are used to prevent malaria in geographic areas where chloroquine resistance is not present.
  • Chloroquine Phosphate tablets are used to treat extraintestinal amebiasis (amoeba infection that has spread beyond the gut).
Important instructions
  • Chloroquine Phosphate tablets are taken by mouth — swallow with water and follow your prescriber's schedule exactly.
  • For malaria prevention, Chloroquine Phosphate is taken once a week on the same day each week; continue for eight weeks after leaving the area.
  • For malaria treatment, Chloroquine Phosphate doses are divided over three days as directed by your prescriber; children's doses are calculated by body weight.
  • For extraintestinal amebiasis, Chloroquine Phosphate is taken daily over several weeks, often alongside another medicine targeting the intestines.
Available strengths 2 strengths
26 FDA-listed product records

📊 Chloroquine across the U.S. market

How Chloroquine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
12
Manufacturers
1
Brand names
29
FDA-listed product records
1949
First marketed

Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Amneal Pharmaceuticals of New York LLC21%
Rising Pharma Holdings, Inc.14%
Suven Pharmaceuticals Limited14%
A-S Medication Solutions7%
Avet Pharmaceuticals Inc.7%
AvKARE7%
Other makers31%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Chloroquine is used

A general measure of how commonly Chloroquine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Chloroquine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

370
Medicaid prescriptions filled (Q1–Q4 2025)
$33,153 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Chloroquine prescribed? Of the 1,596 medications we measure, Chloroquine ranks #1,393 by Medicaid prescriptions — more than 13% of them.

Where Chloroquine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Chloroquine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 250 mg oral tablet is the most-dispensed Chloroquine product — about 96% of these Medicaid prescriptions.

chloroquine phosphate 250 MG Oral Tablet Most dispensed

357 Medicaid prescriptions (Q1–Q4 2025) 96% of Chloroquine prescriptions shown $32,304 gross reimbursement (before rebates) ≈ $90 per prescription (gross)

Summed across the 2 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1117531

chloroquine phosphate 500 MG Oral Tablet

13 Medicaid prescriptions (Q1–Q4 2025) 4% of Chloroquine prescriptions shown $849 gross reimbursement (before rebates) ≈ $65 per prescription (gross)

Summed across the 1 of 14 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1116758

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Chloroquine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 23 listed Chloroquine NDCs with Medicaid activity.

🔍 Compare Chloroquine products

A representative set of FDA-listed product records for Chloroquine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 29 of 29 products — FDA National Drug Code Directory. See every product, package size and price: browse all 29 Chloroquine NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Chloroquine RxCUI 2393 2 dose forms · 5 strengths
  1. Dose form (SCDF) Oral Solution RxCUI 756408 No current FDA listing
    Clinical drug / strength (SCD) phosphate 16 MG/ML RxCUI 1117346 sulfate 13.6 MG/ML RxCUI 1117351
  2. Dose form (SCDF) Oral Tablet RxCUI 371407 In current FDA listings
    Clinical drug / strength (SCD) phosphate 250 MG RxCUI 1117531 phosphate 500 MG RxCUI 1116758 sulfate 200 MG RxCUI 1117353

Look up RxCUI 2393 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Aralen

🏭 Manufacturers & labelers

Amneal Pharmaceuticals of New York LLC 6 Rising Pharma Holdings, Inc. 4 Suven Pharmaceuticals Limited 4 A-S Medication Solutions 2 Avet Pharmaceuticals Inc. 2 AvKARE 2 Bayshore Pharmaceuticals LLC 2 Chartwell RX, LLC 2 Rising Pharmaceuticals, Inc. 2 Cohance Lifesciences Limited 1 Ipca Laboratories Limited 1 Natco Pharma Limited 1

RxNorm drug class

Chloroquine belongs to the Antimalarial class.

Pharmacologic class Antimalarial
Drug family (ATC) Biguanides, Aminoquinolines

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Nov 7, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Chloroquine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Chloroquine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
6
NDC products indexed
29
Distinct labelers/manufacturers represented
12
Linked representative label
Avet Pharmaceuticals Inc.
Linked label effective
Nov 7, 2025
Composite sections available
17
Linked SPL Set ID
f4ac1556-0522-76e3-e053-2a95a90a5ba8
Linked SPL Document ID
ff449b60-19d4-41e8-903c-68bc56fc23e0
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 6 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Avet Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.