Prescription medication · Disease-Modifying Antirheumatic Drug (DMARD)
hydroxychloroquine
Also sold as Plaquenil. This medicine can treat uncomplicated malaria caused by certain parasites.
Data updated 2026-05-15
- 71,900
- FDA reportsOften reported
- 7
- InteractionsFew interactions
- In shortage
- FDA status
What the data shows
hydroxychloroquine (Plaquenil) is a prescription Disease-Modifying Antirheumatic Drug (DMARD), more reported than most tracked drugs (71,900 FDA reports), with 7 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
hydroxychloroquine (Plaquenil) is a prescription Disease-Modifying Antirheumatic Drug (DMARD). This medicine can treat uncomplicated malaria caused by certain parasites.
Hydroxychloroquine is a drug used to treat or prevent malaria, and to treat certain autoimmune diseases. It works by interfering with the immune system and by killing malaria parasites.
Verify with FDA → · CMS NADAC pricing →
Drug Shortage Alert
hydroxychloroquine is currently listed as to be discontinued by the FDA. Affected manufacturer: Teva Pharmaceuticals USA, Inc..
View all drug shortages →Drug Pricing (NADAC)
Generic Price
$0.17/unit
Generic Available
Yes (11 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
NADAC price trail: HYDROXYCHLOROQUINE 100 MG TAB
Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -1.3% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| October 23, 2024 | $0.1706/EA | - | 1 |
| December 18, 2024 | $0.1684/EA | -1.3% | 1 |
What it does
This medicine can treat uncomplicated malaria caused by certain parasites.
Common side effects
Nausea, Vomiting, Diarrhea
Key warnings
This drug can cause heart problems, including a weakened heart muscle and irregular heartbeats.
The sections below are summarized in plain English from hydroxychloroquine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Hydroxychloroquine is an antimalarial and antirheumatic drug. It is thought to work by interfering with the immune system's activity. It also stops the growth of malaria parasites in red blood cells.
Side Effects (from patient reports)
Based on 71,900 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for hydroxychloroquine, by number of reports
- Rheumatoid Arthritis
Rheumatoid Arthritis
12,921 reports
- Pain
Pain
10,409 reports
- Arthralgia
Arthralgia
9,276 reports
- Fatigue
Fatigue
8,853 reports
- Joint Swelling
Joint Swelling
8,528 reports
- Rash
Rash
7,370 reports
- Condition Aggravated
Condition Aggravated
7,013 reports
- Synovitis
Synovitis
6,692 reports
- Nausea
Nausea
6,584 reports
- Contraindicated Product Administered
Contraindicated Product Administered
6,430 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for hydroxychloroquine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where hydroxychloroquine sits
hydroxychloroquine has more FDA adverse-event reports than 80% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is hydroxychloroquine; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 71,900 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
71,900
Reports Mentioning Death
7,814
10.9% of reports — not proof of cause
Hospitalization Reports
20,530
Top Indication
Rheumatoid Arthritis
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 3 | RHEUMATOID ARTHRITIS | 12,921 |
| 4 | PAIN | 10,409 |
| 5 | ARTHRALGIA | 9,276 |
| 7 | FATIGUE | 8,853 |
| 8 | JOINT SWELLING | 8,528 |
| 9 | RASH | 7,370 |
| 10 | CONDITION AGGRAVATED | 7,013 |
| 11 | SYNOVITIS | 6,692 |
| 12 | NAUSEA | 6,584 |
| 13 | CONTRAINDICATED PRODUCT ADMINISTERED | 6,430 |
| 14 | TREATMENT FAILURE | 6,014 |
| 15 | ALOPECIA | 5,939 |
| 16 | HEADACHE | 5,900 |
| 17 | ABDOMINAL DISCOMFORT | 5,881 |
| 18 | ARTHROPATHY | 5,825 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
This drug can cause heart problems, including a weakened heart muscle and irregular heartbeats. It can also cause irreversible damage to your retina, so regular eye exams are needed. This medicine can also cause serious skin reactions. If you have psoriasis or porphyria, talk to your doctor before taking this medicine. It can also cause liver and kidney problems.
Known Drug Interactions
( 7 ) 7.1 Drugs Prolonging QT Interval and Other Arrhythmogenic Drugs Hydroxychloroquine sulfate tablets prolongs the QT interval. There may be an increased risk of inducing ventricular arrhythmias if hydroxychloroquine sulfate tablets are used concomitantly with other arrhythmogenic drugs. Therefore, hydroxychloroquine sulfate tablets are not recommended in patients taking other drugs that have the potential to prolong the QT interval or are arrhythmogenic [see Warnings and Precautions (5.1) ].
Mechanism: Both of these drugs can change the electrical rhythm of your heart. Taking them together increases the risk of a dangerous irregular heartbeat.
7.8 Cimetidine Concomitant use of cimetidine resulted in a 2-fold increase of exposure of chloroquine, which is structurally related to hydroxychloroquine. Interaction of cimetidine with hydroxychloroquine cannot be ruled out. Avoid concomitant use of cimetidine.
Mechanism: Cimetidine can slow down how your body breaks down hydroxychloroquine, which can double the amount of the drug in your system. This makes side effects much more likely.
7.2 Platelet Inhibitors Drugs such as NSAIDS (including salicylic acid, ibuprofen, indomethacin, and celecoxib), dextran, phenylbutazone, thienopyridines, dipyridamole, hydroxychloroquine, glycoprotein IIb/IIIa antagonists (including abciximab, eptifibatide, and tirofiban), and others that interfere with platelet-aggregation reactions (the main hemostatic defense of heparinized patients) may induce bleeding and should be used with caution in patients receiving heparin sodium.
Mechanism: Hydroxychloroquine can interfere with how blood cells stick together to stop bleeding. When taken with a blood thinner like heparin, it increases the chance of serious bleeding.
7 DRUG INTERACTIONS 7.1 Effects of Other Drugs on VEKLURY Due to potential antagonism based on data from cell culture experiments, concomitant use of VEKLURY with chloroquine phosphate or hydroxychloroquine sulfate is not recommended [see Warnings and Precautions (5.3) and Microbiology (12.4) ].
Mechanism: Hydroxychloroquine can interfere with how remdesivir works against the virus. This means the antiviral treatment might not be able to fight the infection effectively.
7.5 Methotrexate Concomitant use of hydroxychloroquine sulfate tablets and methotrexate may increase the incidence of adverse reactions.
Mechanism: Using these two medications at the same time can make it more likely that you will experience side effects.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
What should I do if I experience vision changes while taking this medication?
Can I take this medication with other medications?
How long does it take for this medication to start working for rheumatoid arthritis?
Can this medication cure lupus?
What should I do if I develop a rash while taking this medication?
Is it safe to drink alcohol while taking this medication?
Can this medication affect my blood sugar?
Will this medication protect me from all types of malaria?
Can I stop taking this medication if I feel better?
Are there any long-term side effects I should be aware of?
What are the common side effects of hydroxychloroquine?
Does hydroxychloroquine interact with other medications?
What drug class is hydroxychloroquine?
What pregnancy or breastfeeding source fields are listed for hydroxychloroquine?
Is hydroxychloroquine currently in shortage?
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for hydroxychloroquine: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 71,900.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 10.87%.
- enalapril Δ 0.00 pts · 54,355 reports · ACE Inhibitor 10.87%death share
- ramelteon Δ 0.00 pts · 7,215 reports · Melatonin Receptor Agonist 10.87%death share
- nateglinide Δ 0.04 pts · 1,302 reports · Meglitinide 10.83%death share
- fidaxomicin Δ 0.04 pts · 2,273 reports · Macrocyclic Antibiotic 10.91%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for hydroxychloroquine
The FDA label for hydroxychloroquine (sold under brand names such as Plaquenil) classifies it as a prescription-only medication in the Disease-Modifying Antirheumatic Drug (DMARD) class. This medicine can treat uncomplicated malaria caused by certain parasites. Official labeling lists 6 commonly reported side effects, including Nausea, Vomiting, Diarrhea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 71,900 voluntary reports. The database also lists 7 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.17.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: October 9, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages