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
- 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
- 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:
- difficulty in seeing to read
- itching (more common in black patients)
- loss of appetite
- nausea or vomiting
- stomach cramps or pain
- 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
Frequency not reported: Cardiomyopathy (can result in fatal cardiac failure), biventricular hypertrophy[Ref]
-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]
Very common (10% or more): Abdominal pain, nausea
Common (1% to 10%): Diarrhea, vomiting[Ref]
Frequency not reported: Bone-marrow depression, anemia, aplastic anemia, agranulocytosis, leucopenia, thrombocytopenia[Ref]
Uncommon (0.1% to 1%): Abnormal liver function tests
Frequency not reported: Fulminant hepatic failure[Ref]
Frequency not reported: Allergic reactions (urticaria, angioedema, bronchospasm), hypersensitivity myocarditis[Ref]
Common (1% to 10%): Anorexia
Frequency not reported: Hypoglycemia, exacerbation or precipitation of porphyria[Ref]
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]
Very common (10% or more): Headache
Uncommon (0.1% to 1%): Dizziness
Frequency not reported: Seizure, vertigo, nerve deafness, ataxia[Ref]
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]
Uncommon (0.1% to 1%): Tinnitus
Frequency not reported: Hearing loss[Ref]
Common (1% to 10%): Affect liability
Uncommon (0.1% to 1%): Nervousness
Frequency not reported: Psychosis, suicidal behavior[Ref]
Frequency not reported: Bronchospasm[Ref]
1. "Product Information. Hydroxychloroquine Sulfate (hydroxychloroquine)." Prasco Laboratories, Cincinnati, OH.
2. Cerner Multum, Inc. "Australian Product Information." O 0
3. Cerner Multum, Inc. "UK Summary of Product Characteristics." 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.
More about Plaquenil (hydroxychloroquine)
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- Support Group
- Pricing & Coupons
- En Español
- 89 Reviews – Add your own review/rating
- Generic Availability
- Drug class: antimalarial quinolines
Related treatment guides
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