Generic Name

Hydroxychloroquine

Brand Names
Plaquenil, Sovuna
FDA approval date: January 03, 2008
Classification: Antimalarial
Form: Tablet

What is Plaquenil (Hydroxychloroquine)?

Living with a chronic autoimmune disease like lupus or rheumatoid arthritis can be a relentless journey. The daily experience of joint pain, stiffness, fatigue and skin rashes can wear you down, making even simple tasks feel monumental. The core of these conditions is an immune system that has become overactive, mistakenly attacking the body’s own healthy tissues. Finding a medication that can gently calm this internal storm is the key to regaining control and improving quality of life. For millions, that foundational medication is Hydroxychloroquine.

Hydroxychloroquine is a time-tested prescription medication that belongs to a class of drugs known as disease-modifying antirheumatic drugs (DMARDs). Originally developed to treat malaria, doctors discovered decades ago that it has a profound ability to modulate the immune system. Today, it is a first-line therapy for many autoimmune conditions. It is not a powerful steroid or a heavy-duty immunosuppressant; instead, it works more subtly to restore balance, making it one of the safest and most widely used long-term treatments in rheumatology.

What does Hydroxychloroquine do?

Hydroxychloroquine is a versatile medication approved by the U.S. Food and Drug Administration (FDA) to treat a range of conditions.

Its primary uses in autoimmune disease include:

  • Rheumatoid Arthritis (RA): It helps to reduce joint pain, swelling and stiffness, and may help to prevent long-term joint damage.
  • Systemic Lupus Erythematosus (SLE): It is a cornerstone of lupus treatment, proven to reduce disease flares, improve skin rashes and joint pain, decrease fatigue, and reduce the risk of organ damage.
  • Discoid Lupus: It is effective in treating the skin-only form of lupus.

It is also still used for its original purpose:

  • Malaria: It is used for both the prevention and treatment of certain types of malaria.

Hydroxychloroquine for autoimmune conditions takes 3-6 months for full benefits, significantly improving symptoms and long-term outcomes, often reducing the need for other medications like steroids (American College of Rheumatology, 2023).

How does Hydroxychloroquine work?

The exact mechanism of Hydroxychloroquine is complex, but its main benefit comes from its ability to gently regulate, or “modulate,” the overactive immune system. In autoimmune diseases, immune cells mistakenly identify healthy tissues as foreign invaders and launch an inflammatory attack. This involves a complex communication system where cells release inflammatory proteins called cytokines to call for reinforcements.

Hydroxychloroquine works by getting inside immune cells and interfering with this communication process. Think of it not as shutting down the entire immune system, but rather as turning down the volume on the overactive alarm signals. It disrupts the ability of immune cells to process and present antigens (the substances that trigger the immune response) and reduces the production of inflammatory cytokines.

This calming effect helps to break the cycle of chronic inflammation that causes the joint pain, skin rashes, and fatigue associated with RA and lupus. Its action is targeted and mild compared to stronger immunosuppressants, which is why it is considered a relatively safe option for long-term use. For malaria, it works by interfering with the parasite’s ability to grow and multiply within red blood cells.

Hydroxychloroquine side effects

Hydroxychloroquine is generally well-tolerated, but like all medications, it has potential side effects.

The most common side effects are gastrointestinal and often improve over time:

  • Nausea
  • Stomach cramps or pain
  • Diarrhea
  • Vomiting

Taking the medication with a meal or a glass of milk can often help minimize these issues.

Retinal damage (retinal toxicity/maculopathy), a rare but serious side effect, can affect central vision. This risk is low at recommended doses, mainly occurring after five-plus years or with higher doses.

Other less common side effects can include:

  • Skin rash or itching
  • Headaches
  • Hair lightening or hair loss
  • Muscle weakness

Rarely, this can impact heart muscle (cardiomyopathy) or rhythm. Use cautiously with existing eye, heart, or severe liver conditions. Seek immediate medical care for fainting, rapid heartbeat or severe allergic reaction.

Hydroxychloroquine dosage

Hydroxychloroquine is an oral tablet that is typically taken once or twice a day. Your doctor carefully calculates the dose based on your ideal body weight, not actual weight. This is crucial for long-term eye safety.

Hydroxychloroquine users must undergo routine eye monitoring due to retinal toxicity risk. A baseline eye exam is required within the first year. Annual screenings begin after five years of continuous use, or sooner for high-risk individuals (e.g., kidney disease, pre-existing eye conditions).

This advanced eye exam, conducted by an ophthalmologist, includes specialized tests like visual field examination and SD-OCT to detect early damage before vision changes occur (American Academy of Ophthalmology, 2016). Routine blood work is generally not required unless your doctor has a specific concern.

Does Hydroxychloroquine have a generic version?

Yes, Hydroxychloroquine is widely available as a generic medication. The most well-known brand name is Plaquenil. The U.S. Food and Drug Administration ensures that generic medications are just as safe, effective, and of the same high quality as their brand-name counterparts. The availability of the generic makes this cornerstone treatment very affordable.

Conclusion

Hydroxychloroquine is a vital, effective and relatively safe medication for the long-term management of rheumatoid arthritis and lupus. Its ability to gently calm the immune system helps to control symptoms, prevent disease flares, and improve overall quality of life.

While the potential for eye damage is a serious consideration, the risk is very low and can be managed effectively through proper weight-based dosing and strict adherence to the recommended eye screening schedule. A strong partnership between you, your rheumatologist, and your ophthalmologist is the key to using this medication safely for years to come, allowing you to take an active and confident role in your health journey.

References

  1. American Academy of Ophthalmology. (2016). Recommendations on Screening for Chloroquine and Hydroxychloroquine Retinopathy (2016 Revision). Retrieved from https://www.aao.org/clinical-statement/revised-recommendations-on-screening-for-chloroqui
  2. American College of Rheumatology. (2023). Hydroxychloroquine (Plaquenil). Retrieved from https://www.rheumatology.org/patients/hydroxychloroquine-plaquenil
  3. Mayo Clinic. (2024). Hydroxychloroquine (Oral Route). Retrieved from https://www.mayoclinic.org/drugs-supplements/hydroxychloroquine-oral-route/symptoms/drg-20064216

Top Global Experts

There are no experts for this drug

Save this treatment for later
Sign Up
Not sure about your diagnosis?
Check Your Symptoms

Related Clinical Trials

There is no clinical trials being done for this treatment

Related Latest Advances

There is no latest advances for this treatment

Brand Information

    Plaquenil (Hydroxychloroquine Sulfate)
    1DOSAGE FORMS AND STRENGTHS
    Tablets: 200 mg of hydroxychloroquine sulfate, white to off-white, film-coated tablet imprinted with “PLAQUENIL” on one face in black ink.
    2CONTRAINDICATIONS
    PLAQUENIL is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds.
    3ADVERSE REACTIONS
    The following adverse reactions are described in greater detail in other sections:
    • Renal Toxicity
    The following adverse reactions have been identified during post-approval use of 4-aminoquinoline drugs, including PLAQUENIL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
    4OVERDOSAGE
    PLAQUENIL overdosage symptoms have an onset within 1–3 hours of ingestion. The following have been reported with PLAQUENIL overdosage:
    5DESCRIPTION
    PLAQUENIL (hydroxychloroquine sulfate) is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4- quinolyl) amino]pentyl] ethylamino]ethanol sulfate (1:1) with the molecular formula C
    Hydroxychloroquine sulfate is a white or off-white crystalline powder, freely soluble in water; practically soluble in alcohol, chloroform, and ether.  
    6REFERENCES
    1 Center for Disease Control and Prevention. Malaria.         
    https://www.cdc.gov/parasites/malaria/index.html
    7PATIENT COUNSELING INFORMATION
    Important Administration Instructions
    Advise the patient to take PLAQUENIL with food or milk and not to crush or divide the tablet.

    Cardiomyopathy and Ventricular Arrhythmias
    Inform the patient that serious cardiac effects, life-threatening and fatal cases have been reported with use of PLAQUENIL. Advise patients to seek medical attention immediately if they experience any symptoms of heart rhythm changes including fast or irregular heartbeat, lightheadedness, dizziness, or syncope [see 

    Retinal Toxicity
    Inform the patient that irreversible retinal damage has been observed in some patients with the use of PLAQUENIL. Advise patients of the importance of the ophthalmology visits for monitoring their eyes. Instruct patients to seek medical attention promptly if they experience decreased vision or decreased dark adaptation [see 

    Serious Skin Reactions
    Inform the patient that severe, life-threatening skin reactions have been reported with the use of PLAQUENIL. Advise the patient to seek medical attention immediately if experiencing any of the following signs and symptoms: blisters on the skin, eyes, lips or in the mouth, itching or burning, with or without fever [see .

    Hepatotoxicity Associated with Porphyria Cutanea Tarda
    Inform the patient that liver toxicity has been reported in when PLAQUENIL was used in patients with porphyria cutanea tarda. In some cases, PCT was diagnosed only after the occurrence of liver injury, when PLAQUENIL was prescribed for an approved indication. Advise the patient to seek medical attention if experiencing fatigue, rash, nausea, dark urine, or jaundice [see .

    Skeletal Muscle Myopathy or Neuropathy
    Inform the patient that muscle weakness and atrophy has been reported with PLAQUENIL use. Advise patients to report to the physician symptoms of muscle weakness [see 

    Neuropsychiatric Reactions Including Suicidality
    Alert patients to seek medical attention immediately if they experience new or worsening depression, suicidal thoughts, or other mood changes [see .

    Hypoglycemia
    Inform the patient that PLAQUENIL has been associated with severe hypoglycemia. Advise the patient to monitor blood sugar levels if possible and to seek medical attention if experiencing any of the signs and symptoms of hypoglycemia such as sweating, shakiness, weakness, dizziness, tachycardia, nausea, blurred vision, confusion, fainting, or loss of consciousness [see .

    Pregnancy
    Inform the patient that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to PLAQUENIL during pregnancy. Encourage patients to register by contacting 1-877-311-8972 [see Use in .

    Manufactured for: 
    Advanz Pharma (US) Corp. 
    PLAQUENIL
    8PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 100 TABLET BOTTLE
    plaquenil 100 counts
    NDC 59212-562-10                       Rx only
    9PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 60 TABLET BOTTLE
    pla-60-count
    NDC 59212-562-60                       Rx only
    Plaquenil has been selected.