PrescriptionDrugs.org

Hydroxychloroquine

Key Takeaway

Hydroxychloroquine (brand name Plaquenil) is a disease-modifying antirheumatic drug (DMARD) FDA-approved for the treatment of systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and the prevention and treatment of malaria. It is one of the most commonly prescribed medications for autoimmune conditions, with a well-established safety profile spanning over 60 years of clinical use. Hydroxychloroquine helps control inflammation, reduce disease flares, and prevent joint damage, though its effects take several weeks to months to become apparent.

Medical Disclaimer: This content is for informational purposes only and does not constitute medical advice. Always consult your healthcare provider before starting, stopping, or changing any medication. Using this site does not create a doctor-patient relationship.

Drug information changes as the FDA updates labeling, and we cannot guarantee it is complete or current. Verify critical details with your pharmacist or physician.

Emergencies: If you think you may have a medical emergency, call 911 immediately. For a suspected overdose, call Poison Control at 1-800-222-1222. Report side effects to the FDA MedWatch program at fda.gov/medwatch or 1-800-FDA-1088.

See our Terms of Use and Editorial Policy.

How does Hydroxychloroquine work?

Hydroxychloroquine works by calming an overactive immune system. In autoimmune conditions like lupus and rheumatoid arthritis, your immune system mistakenly attacks your own tissues — joints, skin, kidneys, and other organs. Hydroxychloroquine helps by:

- Reducing inflammation: It decreases the production of chemical signals (cytokines) that drive inflammation throughout your body - Modulating immune cells: It changes how certain white blood cells respond, making them less likely to attack your own tissues - Blocking harmful signals: It interferes with a specific pathway (Toll-like receptors) that triggers autoimmune flares

Unlike painkillers that only mask symptoms, hydroxychloroquine addresses the underlying disease process. However, it works gradually — most people need 2 to 6 months of consistent use before experiencing the full benefit.

What to expect when starting Hydroxychloroquine

Weeks 1-2: You may not notice any benefit yet — hydroxychloroquine takes time to build up in your system. Some people experience mild nausea or stomach discomfort early on, which usually improves with food.

Weeks 2-6: Gradual improvement may begin. You might notice slightly less joint stiffness in the morning or fewer skin flares.

Months 2-6: This is when most people feel the full benefit. Joint pain and swelling decrease, fatigue may improve, and lupus flares become less frequent. Many patients describe it as a "slow but steady" improvement.

Long-term (6+ months): Hydroxychloroquine is intended for long-term use. Studies show it reduces lupus flares by 50-70%, prevents organ damage, and may improve survival in SLE patients [4]. Do not stop taking it without consulting your doctor, even if you feel well — stopping can trigger disease flares.

What are the common side effects of Hydroxychloroquine?

Common

Common(6 effects)
  • Nausea or stomach upset10-20%
  • Diarrhea5-10%
  • Headache5-10%
  • Dizziness3-5%
  • Skin rash or itching3-5%
  • Hair thinning1-3%

What are the serious side effects of Hydroxychloroquine?

Serious

Serious(4 effects)
  • Retinal toxicity (maculopathy)Rare (<2% at 10 years, increasing with duration)
  • QT prolongationRare
  • Severe hypoglycemiaRare
  • Neuromyopathy (muscle weakness)Rare
Life-Threatening(1 effect)
  • CardiomyopathyVery rare

What drugs interact with Hydroxychloroquine?

  • Major
    Tamoxifen Increased risk of retinal toxicity when used together. Avoid combination if possible.
  • Moderate
    Digoxin Hydroxychloroquine may increase digoxin levels. Monitor digoxin concentrations.
  • Moderate
    Methotrexate Both are used together for RA but may have additive hepatotoxic effects. Monitor liver function.
  • Major
    QT-prolonging drugs (azithromycin, ondansetron, others) Additive QT prolongation risk. Use caution and monitor ECG when combining.
  • Moderate
    Insulin and oral hypoglycemics Hydroxychloroquine may enhance hypoglycemic effects. Monitor blood glucose and adjust doses as needed.

View all drug interactions →

Can I eat certain foods or drink alcohol with Hydroxychloroquine?

Food: Hydroxychloroquine should be taken with food or a glass of milk to reduce stomach upset [1]. Food does not significantly affect absorption.

Alcohol: Moderate alcohol use is generally acceptable, but alcohol can worsen liver stress, especially if taking other hepatotoxic medications (e.g., methotrexate) alongside hydroxychloroquine. Alcohol may also worsen lupus symptoms in some patients.

Antacids: Aluminum/magnesium-containing antacids can reduce hydroxychloroquine absorption. Separate doses by at least 4 hours [1].

What is the typical dosage for Hydroxychloroquine?

Lupus (SLE) [1, 4]: - Adults: 200-400 mg daily. Many rheumatologists now recommend dosing based on actual body weight: ≤5 mg/kg/day to minimize retinal toxicity risk. - Common regimen: 200 mg twice daily or 400 mg once daily.

Rheumatoid arthritis [1, 3]: - Adults: 400-600 mg daily initially for 4-12 weeks, then reduce to 200-400 mg daily as maintenance. - Maximum: 600 mg/day.

Malaria prophylaxis [1]: - Adults: 400 mg once weekly, starting 2 weeks before travel and continuing 4 weeks after leaving the endemic area. - Children: 6.5 mg/kg once weekly (max 400 mg).

Important notes: - Dose should not exceed 5 mg/kg/day (actual body weight) for long-term use to reduce retinal toxicity risk [5]. - Available as 200 mg tablets. - No dose adjustment needed for mild-moderate renal impairment.

How much does Hydroxychloroquine cost?

Generic hydroxychloroquine is widely available and is one of the most affordable prescription medications for autoimmune diseases [7, 8].

Pricing comparison: - Generic hydroxychloroquine 200 mg: $10-30/month - Brand Plaquenil 200 mg: $400-600/month (rarely prescribed)

The FDA-rated generic is therapeutically equivalent (AB-rated). Insurance coverage is excellent for both lupus and RA indications. Many discount programs offer 30-day supplies for under $15.

Is Hydroxychloroquine safe during pregnancy or breastfeeding?

Pregnancy: Hydroxychloroquine is one of the few DMARDs considered relatively safe in pregnancy and is often continued throughout pregnancy in women with lupus [1, 6]. Stopping HCQ during pregnancy can trigger potentially dangerous lupus flares. The American College of Rheumatology (ACR) recommends continuing hydroxychloroquine during pregnancy for women with SLE.

- FDA category: Not formally categorized under the old system, but extensive data support safety - Studies show no increased risk of congenital malformations [6] - May reduce the risk of neonatal lupus and congenital heart block

Breastfeeding: Hydroxychloroquine is excreted in breast milk in small amounts. The American Academy of Pediatrics considers it compatible with breastfeeding [1, 6]. The infant dose from breast milk is estimated at <2% of the maternal dose.

Is there a generic version of Hydroxychloroquine?

Generic hydroxychloroquine (available since the 1950s, well before patent considerations) is the standard of care. Brand-name Plaquenil is still manufactured but rarely prescribed due to the large cost difference. The generic is FDA-rated as therapeutically equivalent. There are no clinically meaningful differences between manufacturers.

For Caregivers

Medication management: - Help ensure the medication is taken consistently, ideally at the same time each day with food. - Use a pill organizer if managing multiple medications. - Do NOT crush or split the tablets unless directed by a pharmacist.

Eye exams are critical: - The most important monitoring requirement is regular ophthalmologic screening for retinal toxicity [5]. - Baseline eye exam within the first year, then annually after 5 years of use (or sooner if risk factors present). - Risk factors for retinal toxicity: dose >5 mg/kg/day, use >5 years, kidney disease, tamoxifen use, pre-existing macular disease.

Signs to watch for: - Changes in vision (blurriness, difficulty reading, color vision changes) — report immediately - Muscle weakness — could indicate rare neuromyopathy - Irregular heartbeat — very rare but requires evaluation

Frequently asked questions about Hydroxychloroquine

References

  1. [Regulatory] Plaquenil (hydroxychloroquine sulfate) FDA Prescribing Information. Sanofi. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009768s037s045s047lbl.pdf Accessed 2025-01-15.
  2. [Regulatory] Schrezenmeier E, Dörner T. Mechanisms of action of hydroxychloroquine and chloroquine: implications for rheumatology. Nat Rev Rheumatol. 2020;16(3):155-166. https://pubmed.ncbi.nlm.nih.gov/21885490/
  3. [Clinical] UpToDate: Antimalarial drugs in the treatment of rheumatic disease. Accessed 2025. https://www.uptodate.com/contents/antimalarial-drugs-in-the-treatment-of-rheumatic-disease
  4. [Regulatory] Akhavan PS et al. The early protective effect of hydroxychloroquine on the risk of cumulative damage in patients with SLE. J Rheumatol. 2013;40(6):831-841. https://pubmed.ncbi.nlm.nih.gov/26724186/
  5. [Regulatory] American Academy of Ophthalmology. Recommendations on Screening for Chloroquine and Hydroxychloroquine Retinopathy (2016 Revision). https://www.aao.org/education/clinical-statement/revised-recommendations-on-screening-chloroquine-
  6. [Regulatory] Götestam Skorpen C et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016;75(5):795-810. https://pubmed.ncbi.nlm.nih.gov/27467726/
  7. [Observational] GoodRx: Hydroxychloroquine pricing and savings information. https://www.goodrx.com/hydroxychloroquine
  8. [Clinical] Drugs.com: Hydroxychloroquine drug information. https://www.drugs.com/hydroxychloroquine.html

Written and fact-checked by PrescriptionDrugs.org Editorial Team

Last updated: