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Plaquenil Side Effects

Generic Name: hydroxychloroquine

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.

For the Consumer

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
  • Blistering, peeling, loosening of the skin
  • blurred vision or other vision changes
  • chest discomfort, pain, or tightness
  • cough or hoarseness
  • dark urine
  • decreased urination
  • defective color vision
  • diarrhea
  • difficulty breathing
  • difficulty seeing at night
  • dizziness or fainting
  • fast, pounding, uneven heartbeat
  • feeling that others are watching you or controlling your behavior
  • feeling that others can hear your thoughts
  • feeling, seeing, or hearing things that are not there
  • fever with or without chills
  • general feeling of tiredness or weakness
  • headache
  • inability to move the eyes
  • increased blinking or spasms of the eyelid
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, and sex organs
  • loss of hearing
  • lower back or side pain
  • noisy breathing
  • painful or difficult urination
  • red irritated eyes
  • red skin lesions, often with a purple center
  • severe mood or mental changes
  • sore throat sores, ulcers, or white spots on the lips or in the mouth
  • sticking out of the tongue
  • stomach pain
  • swelling of the feet or lower legs
  • swollen or painful glands
  • trouble with breathing, speaking, or swallowing
  • uncontrolled twisting movements of the neck, trunk, arms, or legs
  • unusual behavior
  • unusual bleeding or bruising
  • unusual facial expressions
  • unusual tiredness or weakness
  • yellow eyes or skin
Symptoms of overdose
  • Drowsiness
  • dry mouth
  • increased thirst
  • loss of appetite
  • mood changes
  • no pulse or blood pressure
  • numbness or tingling in the hands, feet, or lips
  • unconsciousness

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
  • Continuing ringing or buzzing or other unexplained noise in the ears
  • feeling of constant movement of self or surroundings
  • irritability
  • nausea
  • nervousness
  • nightmares
  • sensation of spinning
  • shakiness and unsteady walk
  • uncontrolled eye movements
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • vomiting

For Healthcare Professionals

Applies to hydroxychloroquine: compounding powder, oral tablet

Cardiovascular

Frequency not reported: Cardiomyopathy (can result in fatal cardiac failure), biventricular hypertrophy[Ref]

Dermatologic

-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[Ref]

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)[Ref]

Gastrointestinal

Very common (10% or more): Abdominal pain, nausea
Common (1% to 10%): Diarrhea, vomiting[Ref]

Hematologic

Frequency not reported: Bone-marrow depression, anemia, aplastic anemia, agranulocytosis, leucopenia, thrombocytopenia[Ref]

Hepatic

Uncommon (0.1% to 1%): Abnormal liver function tests
Frequency not reported: Fulminant hepatic failure[Ref]

Hypersensitivity

Frequency not reported: Allergic reactions (urticaria, angioedema, bronchospasm), hypersensitivity myocarditis[Ref]

Metabolic

Common (1% to 10%): Anorexia
Frequency not reported: Hypoglycemia, exacerbation or precipitation of porphyria[Ref]

Musculoskeletal

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[Ref]

Myopathy may be reversible after therapy discontinuation, but recovery may take many months.[Ref]

Nervous system

Very common (10% or more): Headache
Uncommon (0.1% to 1%): Dizziness
Frequency not reported: Seizure, vertigo, nerve deafness, ataxia[Ref]

Ocular

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[Ref]

-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.[Ref]

Other

Uncommon (0.1% to 1%): Tinnitus
Frequency not reported: Hearing loss[Ref]

Psychiatric

Common (1% to 10%): Affect liability
Uncommon (0.1% to 1%): Nervousness
Frequency not reported: Psychosis, suicidal behavior[Ref]

Respiratory

Frequency not reported: Bronchospasm[Ref]

References

1. "Product Information. Hydroxychloroquine Sulfate (hydroxychloroquine)." Prasco Laboratories, Cincinnati, OH.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Some side effects of Plaquenil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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