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Plaquenil Side Effects

Generic Name: hydroxychloroquine

Note: This page contains side effects data for the generic drug hydroxychloroquine. It is possible that some of the dosage forms included below may not apply to the brand name Plaquenil.

For the Consumer

Applies to hydroxychloroquine: oral tablet

As well as its needed effects, hydroxychloroquine (the active ingredient contained in Plaquenil) may cause unwanted side effects that require medical attention. When this medicine is used for short periods of time, side effects usually are rare. However, when it is used for a long time and/or in high doses, side effects are more likely to occur and may be serious.

Major Side Effects

If any of the following side effects occur while taking hydroxychloroquine, check with your doctor immediately:

Less common:
  • Blurred vision or any other change in vision—this side effect may also occur or get worse after you Stop taking hydroxychloroquine
Rare
  • Convulsions (seizures)
  • increased muscle weakness
  • mood or other mental changes
  • ringing or buzzing in ears or any loss of hearing
  • sore throat and fever
  • unusual bleeding or bruising
  • unusual tiredness
  • weakness
Symptoms of overdose:
  • Drowsiness
  • headache
  • increased excitability

Minor Side Effects

Some hydroxychloroquine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Diarrhea
  • difficulty in seeing to read
  • headache
  • itching (more common in black patients)
  • loss of appetite
  • nausea or vomiting
  • stomach cramps or pain
Less common:
  • Bleaching of hair or increased hair loss
  • blue-black discoloration of skin, fingernails, or inside of mouth
  • dizziness or lightheadedness
  • nervousness or restlessness
  • skin rash

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

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

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

It is possible that some side effects of Plaquenil may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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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