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Note: This document contains side effect information about hydroxychloroquine. Some of the dosage forms listed on this page may not apply to the brand name Plaquenil.
Applies to hydroxychloroquine: oral tablet
Along with its needed effects, hydroxychloroquine (the active ingredient contained in Plaquenil) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking hydroxychloroquine:
Incidence not known
Symptoms of overdose
Some side effects of hydroxychloroquine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
Applies to hydroxychloroquine: compounding powder, oral tablet
Frequency not reported: Cardiomyopathy (can result in fatal cardiac failure), biventricular hypertrophy
-Pigmentary changes in skin and mucous membranes, bleaching of hair, and alopecia are usually reversible when therapy is discontinued.
-AGEP should be distinguished from psoriasis, although this drug may precipitate attacks of psoriasis; it may be associated with fever and hyperleukocytosis
Common (1% to 10%): Rash, pruritus
Uncommon (0.1% to 1%): Pigmentary changes in skin and mucous membranes, bleaching of hair, alopecia
Frequency not reported: Urticaria, angioedema, bullous eruptions including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome) photosensitivity, exfoliative dermatitis, acute generalized exanthematous pustulosis (AGEP)
Very common (10% or more): Abdominal pain, nausea
Common (1% to 10%): Diarrhea, vomiting
Frequency not reported: Bone-marrow depression, anemia, aplastic anemia, agranulocytosis, leucopenia, thrombocytopenia
Uncommon (0.1% to 1%): Abnormal liver function tests
Frequency not reported: Fulminant hepatic failure
Frequency not reported: Allergic reactions (urticaria, angioedema, bronchospasm), hypersensitivity myocarditis
Common (1% to 10%): Anorexia
Frequency not reported: Hypoglycemia, exacerbation or precipitation of porphyria
Uncommon (0.1% to 1%): Sensorimotor disorders
Frequency not reported: Skeletal muscle myopathy or neuromyopathy (leading to progressive weakness and atrophy of proximal muscle groups), depression of tendon reflexes and abnormal nerve conduction studies
Myopathy may be reversible after therapy discontinuation, but recovery may take many months.
Very common (10% or more): Headache
Uncommon (0.1% to 1%): Dizziness
Frequency not reported: Seizure, vertigo, nerve deafness, ataxia
Common (1% to 10%): Blurred vision
Uncommon (0.1% to 1%): Retinopathy (with changes in pigmentation and visual field defects), corneal changes haloes (e.g., blurring of vision, photophobia)
Frequency not reported: Maculopathies and macular degeneration (may be irreversible), extra-ocular muscle palsies (reversible), nystagmus
-Blurring of vision is due to a disturbance of accommodation which is dose dependent and reversible.
-Retinopathy is uncommon if the recommended daily dose is not exceeded. It is usually reversible if therapy is discontinued. If allowed to develop, there may be a risk of progression even after treatment withdrawal.
-Patients with retinal changes may be asymptomatic initially, or may have scotomatous vision with paracentral, pericentral ring types, temporal scotomas, and abnormal color vision.
-Corneal changes including edema and opacities can be symptomless or may cause disturbances such as haloes, blurring of vision or photophobia. They may be transient and are reversible when therapy is discontinued.
-Maculopathies and macular degeneration can occur from 3 months to several years of exposure to this drug and may be irreversible.
Uncommon (0.1% to 1%): Tinnitus
Frequency not reported: Hearing loss
Common (1% to 10%): Affect liability
Uncommon (0.1% to 1%): Nervousness
Frequency not reported: Psychosis, suicidal behavior
Frequency not reported: Bronchospasm