Medical Editor: John P. Cunha, DO, FACOEP
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. Common side effects of Plaquenil include
- nausea,
- vomiting,
- stomach pain or cramps,
- loss of appetite,
- weight loss,
- diarrhea,
- dizziness,
- spinning sensation,
- headache,
- ringing in your ears,
- mood changes,
- nervousness,
- irritability,
- skin rash,
- itching, or
- hair loss.
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).
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. 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 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.
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.
Some people taking this medication over long periods of time or at high doses have developed irreversible damage to the retina of the eye. Stop taking hydroxychloroquine and call your doctor at once if you have trouble focusing, if you see light streaks or flashes in your vision, or if you notice any swelling or color changes in your eyes.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- muscle weakness, twitching, or 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
- seizure (convulsions).
Less serious side effects may include:
- headache, ringing in your ears, spinning sensation;
- nausea, vomiting, stomach pain;
- loss of appetite, weight loss;
- mood changes, 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)
SIDE EFFECTS
Psychiatric Disorders
Nervousness, emotional lability, psychosis, suicidal behavior.
Nervous System Disorders
Dizziness, headache, and convulsions have been reported with this class of drugs.
Eye Disorders
Retinopathy with changes in pigmentation and visual field defects have been reported. In its early form, it appears reversible on discontinuation of hydroxychloroquine. If allowed to develop, there may be a risk of progression even after treatment withdrawal. Cases of maculopathies and macular degeneration have been reported and may be irreversible.
Skin And Subcutaneous Tissue Disorders
Bullous eruptions including very rare cases of Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity, and exfoliative dermatitis have been reported.Not all of the following reactions have been observed with every 4-aminoquinoline compound during long-term therapy, but they have been reported with one or more and should be borne in mind when drugs of this class are administered. Adverse effects with different compounds vary in type and frequency.
Not all of the following reactions have been observed with every 4-aminoquinoline compound during long-term therapy, but they have been reported with one or more and should be borne in mind when drugs of this class are administered. Adverse effects with different compounds vary in type and frequency.
CNS Reactions
Irritability, nervousness, emotional changes, nightmares, psychosis, headache, dizziness, vertigo, tinnitus, nystagmus, nerve deafness, convulsions, ataxia and suicidal behavior.
Neuromuscular Reactions
Skeletal muscle palsies or skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups which may be associated with mild sensory changes, depression of tendon reflexes and abnormal nerve conduction.
Ocular Reactions
A. Ciliary body: Disturbance of accommodation with symptoms of blurred vision. This reaction is doserelated and reversible with cessation of therapy.
B. Cornea: Transient edema, punctate to lineal opacities, decreased corneal sensitivity. The corneal changes, with or without accompanying symptoms (blurred vision, halos around lights, photophobia), are fairly common, but reversible. Corneal deposits may appear as early as three weeks following initiation of therapy.
The incidence of corneal changes and visual side effects appears to be considerably lower with hydroxychloroquine than with chloroquine.
C. Retina: Macula: Edema, atrophy, abnormal pigmentation (mild pigment stippling to a "bull's-eye" appearance), loss of foveal reflex, increased macular recovery time following exposure to a bright light (photo-stress test), elevated retinal threshold to red light in macular, paramacular, and peripheral retinal areas. Cases of maculopathies and macular degeneration have been reported and may be irreversible.
Other fundus changes include optic disc pallor and atrophy, attenuation of retinal arterioles, fine granular pigmentary disturbances in the peripheral retina and prominent choroidal patterns in advanced stage.
D. Visual field defects: Pericentral or paracentral scotoma, central scotoma with decreased visual acuity, rarely field constriction, abnormal color vision.
The most common visual symptoms attributed to the retinopathy are: reading and seeing difficulties (words, letters, or parts of objects missing), photophobia, blurred distance vision, missing or blacked out areas in the central or peripheral visual field, light flashes and streaks.
Retinopathy appears to be dose related and has occurred within several months (rarely) to several years of daily therapy; a small number of cases have been reported several years after antimalarial drug therapy was discontinued. It has not been noted during prolonged use of weekly doses of the 4- aminoquinoline compounds for suppression of malaria.
Patients with retinal changes may have visual symptoms or may be asymptomatic (with or without visual field changes). Rarely scotomatous vision or field defects may occur without obvious retinal change.
Retinopathy may progress even after the drug is discontinued. In a number of patients, early retinopathy (macular pigmentation sometimes with central field defects) diminished or regressed completely after therapy was discontinued. If allowed to develop, there may be a risk of progression even after treatment withdrawal. Paracentral scotoma to red targets (sometimes called "premaculopathy") is indicative of early retinal dysfunction which is usually reversible with cessation of therapy.
A small number of cases of retinal changes have been reported as occurring in patients who received only hydroxychloroquine. These usually consisted of alteration in retinal pigmentation which was detected on periodic ophthalmologic examination; visual field defects were also present in some instances. A case of delayed retinopathy has been reported with loss of vision starting one year after administration of hydroxychloroquine had been discontinued.
Dermatologic Reactions
Bleaching of hair, alopecia, pruritus, skin and mucosal pigmentation, photosensitivity, and skin eruptions (urticarial, morbilliform, lichenoid, maculopapular, purpuric, erythema multiforme, erythema annulare centrifugum, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and exfoliative dermatitis).
Hematologic Reactions
Various blood dyscrasias such as aplastic anemia, agranulocytosis, leukopenia, anemia, thrombocytopenia (hemolysis in individuals with glucose-6-phosphate dehydrogenase (G-6- PD) deficiency).
Gastrointestinal Reactions
Anorexia, nausea, vomiting, diarrhea, and abdominal cramps. Isolated cases of abnormal liver function and fulminant hepatic failure.
Allergic Reactions
Urticaria, angioedema and bronchospasm have been reported.
Miscellaneous Reactions
Weight loss, lassitude, exacerbation or precipitation of porphyria and nonlight-sensitive psoriasis.
Cardiomyopathy has been rarely reported with high daily dosages of hydroxychloroquine.
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)
Read the Plaquenil User Reviews »
© 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.
