Hydroxychloroquine is used to treat or prevent malaria, a disease caused by parasites that enter the body through the bite of a mosquito. or against malaria in areas where the infection has been resistant to a similar drug called chloroquine. Hydroxychloroquine is not effective against all strains of malaria,

Hydroxychloroquine is also used to treat symptoms of rheumatoid arthritis and discoid or systemic lupus erythematosus.

Hydroxychloroquine may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to hydroxychloroquine or chloroquine.

Tell your doctor if you are pregnant or plan to become pregnant. Having malaria during pregnancy may also increase the risk of miscarriage, stillbirth, premature delivery, and low birth weight. Malaria is more likely to cause serious illness or death in a pregnant woman.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of hydroxychloroquine on the baby.

It is not known whether hydroxychloroquine will harm an unborn baby. If you are pregnant, ask your doctor about the risks of traveling to areas where malaria is common (such as Africa, South America, and Southern Asia).

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Hydroxychloroquine is not approved for treating lupus or rheumatoid arthritis in anyone younger than 18 years old.

High doses or long-term use of hydroxychloroquine may cause (the membrane layer inside your eye that helps produce vision). This could progress to . The risk of retinal damage is higher in people with pre-existing eye problems, kidney disease, or people who also take tamoxifen. irreversible damage to your retinapermanent vision problems

Tell your doctor if you have ever had:

• vision changes or damage to your retina caused by an anti-malaria medication;
• heart disease, heart rhythm disorder (such as long QT syndrome);
• diabetes;
• a stomach disorder;
• an allergy to quinine;
• liver or kidney disease;
• psoriasis;
• alcoholism;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system); or
• a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Use Plaquenil Sulfate (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have (hives, difficult breathing, swelling in your face or throat) (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling). signs of an allergic reactionor a severe skin reaction

Also seek emergency medical attention if you have symptoms of a serious heart problem: fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out).

Call your doctor at once if you have:

Taking hydroxychloroquine long-term or at high doses may cause irreversible damage to the retina of your eye. Stop taking hydroxychloroquine and tell your doctor if you have:

• a seizure;
• yellowing of your eyes;
• ringing in your ears, trouble hearing;
• unusual mood changes;
• severe muscle weakness, loss of coordination, underactive reflexes;
• any sudden changes in mood or behavior, or thoughts about suicide;
• low blood cell counts--fever, chills, tiredness, sore throat, mouth sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• low blood sugar--headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; or
• a serious drug reaction that can affect many parts of your body--skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

• blurred vision, trouble focusing, trouble reading;
• distorted vision, blind spots;
• changes in your color vision;
• hazy or cloudy vision;
• seeing light flashes or streaks, seeing halos around lights; or
• increased sensitivity to light.

• headache, dizziness;
• nausea, vomiting, stomach pain;
• loss of appetite, weight loss;
• feeling nervous or irritable;
• skin rash or itching; or
• hair loss.

Common side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This medicine may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Avoid taking an antacid or Kaopectate (kaolin-pectin) within 4 hours before or 4 hours after you take hydroxychloroquine.