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Plaquenil

Last reviewed on RxList: 2/19/2020
Plaquenil Side Effects Center

What Is Plaquenil?

Plaquenil (hydroxychloroquine) is an antimalarial medication used to treat or prevent malaria, a disease caused by parasites, which enter the body through the bite of a mosquito. Plaquenil is also used to treat symptoms of rheumatoid arthritis and discoid or systemic lupus erythematosus. Plaquenil is available in generic form.

What Are Side Effects of Plaquenil?

Common side effects of Plaquenil include

Tell your doctor if you experience serious side effects of Plaquenil including

  • muscle weakness,
  • twitching,
  • uncontrolled movement,
  • loss of balance or coordination,
  • blurred vision,
  • light sensitivity,
  • seeing halos around lights,
  • pale skin,
  • easy bruising or
  • bleeding,
  • confusion,
  • unusual thoughts or behavior, or
  • seizures (convulsions).

Dosage for Plaquenil

The adult dose of Plaquenil to suppress malaria is 400 mg on the same day each week. The pediatric weekly suppressive dosage is 5 mg/kg of body weight. The adult dose of Plaquenil to treat an acute attack of malaria is an initial dose of 800 mg followed by 400 mg in six to eight hours and 400 mg for two more days. To treat lupus erythematosus, the average adult dose is 400 mg once or twice daily.

What Drugs, Substances, or Supplements Interact with Plaquenil?

Plaquenil may interact with acetaminophen, cancer medications, tuberculosis medications, birth control pills or hormone replacement therapy, arthritis medications, ACE inhibitors, antibiotics, antifungals, cholesterol medications, HIV/AIDS medications, NSAIDs (non-steroidal anti-inflammatory drugs), or seizure medications. Tell your doctor all medications you use.

Plaquenil During Pregnancy and Breastfeeding

Plaquenil should be used only when prescribed during pregnancy. This medication is not recommended to treat rheumatoid arthritis during pregnancy. This medication passes into breast milk. Consult your doctor before breast-feeding.

Additional Information

Our Plaquenil (hydroxychloroquine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

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Plaquenil Consumer Information

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

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:

  • a seizure;
  • yellowing of your eyes;
  • ringing in your ears, trouble hearing;
  • unusual mood changes;
  • severe muscle weakness, loss of coordination, underactive reflexes;
  • 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.

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:

  • 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.

Common side effects may include:

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

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.

Read the entire detailed patient monograph for Plaquenil (Hydroxychloroquine)

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Plaquenil Professional Information

SIDE EFFECTS

The following adverse reactions have been identified during post-approval use of PLAQUENIL or other 4-aminoqunoline compounds. 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.

Blood and lymphatic system disorders : Bone marrow failure, anemia, aplastic anemia, agranulocytosis, leukopenia, and thrombocytopenia. Hemolysis reported in individuals with glucose-6- phosphate dehydrogenase (G-6-PD) deficiency.

Cardiac disorders : Cardiomyopathy which may result in cardiac failure and in some cases a fatal outcome (see WARNINGS and OVERDOSAGE). PLAQUENIL prolongs the QT interval. Ventricular arrhythmias and torsade de pointes have been reported in patients taking PLAQUENIL (see OVERDOSAGE and DRUG INTERACTIONS).

Ear and labyrinth disorders : Vertigo, tinnitus, nystagmus, nerve deafness, deafness.

Eye disorders : Irreversible retinopathy with retinal pigmentation changes (bull's eye appearance), visual field defects (paracentral scotomas) and visual disturbances (visual acuity), maculopathies (macular degeneration), decreased dark adaptation, color vision abnormalities, corneal changes (edema and opacities) including corneal deposition of drug with or without accompanying symptoms (halo around lights, photophobia, blurred vision).

Gastrointestinal disorders : Nausea, vomiting, diarrhea, and abdominal pain.

General disorders and administration site conditions : Fatigue.

Hepatobiliary disorders : Liver function tests abnormal, hepatic failure acute.

Immune system disorders : Urticaria, angioedema, bronchospasm

Metabolism and nutrition disorders : Decreased appetite, hypoglycemia, porphyria, weight decreased.

Musculoskeletal and connective tissue disorders : Sensorimotor disorder, skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups, depression of tendon reflexes and abnormal nerve conduction.

Nervous system disorders : Headache, dizziness, seizure, ataxia and extrapyramidal disorders such as dystonia, dyskinesia, and tremor have been reported with this class of drugs.

Psychiatric disorders : Affect/emotional lability, nervousness, irritability, nightmares, psychosis, suicidal behavior.

Skin and subcutaneous tissue disorders : Rash, pruritus, pigmentation disorders in skin and mucous membranes, hair color changes, alopecia. Dermatitis bullous eruptions including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), photosensitivity, dermatitis exfoliative, acute generalized exanthematous pustulosis (AGEP). AGEP has to be distinguished from psoriasis, although PLAQUENIL may precipitate attacks of psoriasis. It may be associated with pyrexia and hyperleukocytosis.

To report SUSPECTED ADVERSE REACTIONS, contact Concordia Pharmaceuticals Inc. at 1- 877-370-1142 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Read the entire FDA prescribing information for Plaquenil (Hydroxychloroquine)

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© Plaquenil Patient Information is supplied by Cerner Multum, Inc. and Plaquenil Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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