Sovuna Side Effects

Generic name: hydroxychloroquine

Medically reviewed by Drugs.com. Last updated on Nov 19, 2024.

Note: This document provides detailed information about Sovuna.

Applies to hydroxychloroquine: oral tablet Side Effects associated with hydroxychloroquine. Some dosage forms listed on this page may not apply specifically to the brand name Sovuna.

Applies to hydroxychloroquine: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Check with your doctor immediately if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, including QT prolongation.

This medicine may cause muscle and nerve problems. Check with your doctor right away if you have muscle weakness, pain, or tenderness while using this medicine.

Hydroxychloroquine may cause some people to be agitated, irritable, or display other abnormal behaviors within the first month after the start of treatment. It may also cause some people to have suicidal thoughts and tendencies, or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with certain medicines. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. Check with your doctor immediately if you think you are getting an infection or if you get a fever, chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis can occur during treatment with this medicine. Check with your doctor right away if you or your child have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, severe acne or skin rash, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness while you are using this medicine.

If your symptoms do not improve within a few days (or a few weeks or months for arthritis), or if they become worse, check with your doctor.

Malaria is spread by the bites of certain kinds of infected female mosquitoes. If you are living in or will be traveling to an area where there is a chance of getting malaria, the following mosquito-control measures will help to prevent infection:

• If possible, avoid going out between dusk and dawn because it is at these times that mosquitoes most commonly bite.
• Remain in air-conditioned or well-screened rooms to reduce contact with mosquitoes.
• Wear long-sleeved shirts or blouses and long trousers to protect your arms and legs, especially from dusk through dawn when mosquitoes are out.
• Apply insect repellant, preferably one containing DEET, to uncovered areas of the skin from dusk through dawn when mosquitoes are out.
• If possible, sleep in a screened or air-conditioned room or under mosquito netting preferably netting coated or soaked with pyrethrum, to avoid being bitten by malaria-carrying mosquitoes.
• Use mosquito coils or sprays to kill mosquitoes in living and sleeping quarters during evening and nighttime hours.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines) and herbal or vitamin supplements.

Serious side effects of Sovuna

Along with its needed effects, hydroxychloroquine (the active ingredient contained in Sovuna) 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:

Get emergency help immediately if any of the following symptoms of overdose occur while taking hydroxychloroquine:

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

Other side effects of Sovuna

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:

For healthcare professionals

Applies to hydroxychloroquine: compounding powder, oral tablet.

Cardiovascular adverse events

• Rare (0.01% to 0.1%): Cardiomyopathy (sometimes resulting in cardiac failure; some with fatal outcome),
• Frequency not reported: Arrhythmia (torsade de pointes, ventricular tachycardia), conduction disorders (bundle branch block/atrioventricular heart block), biventricular hypertrophy, QT interval prolongation, ventricular arrhythmias, torsade de pointes, sick sinus syndrome, pulmonary hypertension^[Ref]

QT interval prolongation has been reported in patients with specific risk factors, which may lead to arrhythmia (torsade de pointes, ventricular tachycardia).^[Ref]

Ocular

• Common (1% to 10%): Blurred vision (including due to disturbance of accommodation)
• Uncommon (0.1% to 1%): Retinopathy (with changes in pigmentation, visual field defects), retinal changes (including paracentral, pericentral ring types, temporal scotomas, abnormal color vision), corneal changes (including edema, opacities), haloes, photophobia
• Very rare (less than 0.01%): Extraocular muscle palsies
• Frequency not reported: Maculopathies, macular degeneration, abnormal macular pigmentation and depigmentation (sometimes with bull's eye appearance), pallor of optic disc, optic atrophy, narrowing of retinal arterioles
• Postmarketing reports: Irreversible retinopathy with retinal pigmentation changes (bull's eye appearance), visual field defects (paracentral scotomas), visual disturbances (visual acuity), maculopathies (macular degeneration), decreased dark adaptation, color vision abnormalities, corneal changes (edema, opacities), corneal deposition of drug with or without accompanying symptoms (halo around lights, photophobia, blurred vision^[Ref]

Blurred vision (temporary) and extraocular muscle palsies (reversible) were due to disturbance of accommodation, which was dose dependent and reversible.

Retinopathy appeared to be uncommon when the recommended daily dose was not exceeded. In its early form, it appeared reversible when therapy was discontinued. If allowed to develop, there was risk of progression even after treatment withdrawal.

Patients with retinal changes were asymptomatic initially or had scotomatous vision with paracentral, pericentral ring types, temporal scotomas, and abnormal color vision.

Corneal changes (including edema and opacities) have occurred from 3 weeks (infrequently) to some years after starting therapy. These changes were either symptomless or caused disturbances such as haloes, blurred vision, or photophobia; they may be transient and were reversible when therapy was discontinued.

Maculopathies and macular degeneration have been reported (onset ranging from 3 months to several years of exposure to this drug) and may be irreversible.^[Ref]

Gastrointestinal

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

In general, abdominal pain, nausea, diarrhea, and vomiting resolved immediately when the dose was reduced or therapy was stopped.^[Ref]

Dermatologic

• Common (1% to 10%): Skin rash, pruritus, alopecia
• Uncommon (0.1% to 1%): Pigmentary changes, pigmentation disorders in skin and mucous membranes, bleaching of hair
• Rare (0.01% to 0.1%): Attacks of psoriasis
• Very rare (less than 0.01%): Dermatitis bullous eruptions, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) syndrome, photosensitivity, exfoliative dermatitis, acute generalized exanthematous pustulosis (AGEP)
• Frequency not reported: Urticaria, angioedema
• Postmarketing reports: Hair color changes^[Ref]

In general, skin rash, pruritus, pigmentation disorders in skin and mucous membranes, bleaching of hair, and alopecia resolved readily when therapy was discontinued.

AGEP had to be distinguished from psoriasis, although this drug has precipitated attacks of psoriasis. AGEP has been associated with fever and hyperleukocytosis. In general, outcome was favorable after stopping this drug.^[Ref]

Metabolic

• Common (1% to 10%): Anorexia
• Rare (0.01% to 0.1%): Exacerbation/precipitation of porphyria
• Postmarketing reports: Hypoglycemia, decreased appetite, porphyria^[Ref]

Nervous system

• Common (1% to 10%): Headache
• Uncommon (0.1% to 1%): Dizziness, nerve deafness, vertigo, tinnitus
• Rare (0.01% to 0.1%): Seizure/convulsions, neuromyopathy
• Very rare (less than 0.01%): Nystagmus, ataxia
• Frequency not reported: Hearing loss
• Postmarketing reports: Extrapyramidal disorders (e.g., dystonia, dyskinesia, tremor), deafness^[Ref]

Psychiatric

• Common (1% to 10%): Affect/emotional lability
• Uncommon (0.1% to 1%): Nervousness
• Very rare (less than 0.01%): Psychosis, suicidal behavior, nightmares
• Postmarketing reports: Irritability^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Abnormal liver function tests
• Very rare (less than 0.01%): Fulminant hepatitis
• Postmarketing reports: Acute/fulminant hepatic failure^[Ref]

Musculoskeletal

• Uncommon (0.1% to 1%): Sensorimotor disorders
• Frequency not reported: Absent/hypoactive deep tendon reflexes
• Postmarketing reports: Skeletal muscle myopathy/muscle weakness/neuromyopathy (leading to progressive weakness, atrophy of proximal muscle groups), depression of tendon reflexes, abnormal nerve conduction studies^[Ref]

Myopathy has been reversible after therapy discontinuation, but recovery has taken many months.^[Ref]

Hematologic

• Rare (0.01% to 0.1%): Bone-marrow failure/depression, anemia, aplastic anemia, leukopenia, thrombocytopenia
• Very rare (less than 0.01%): Agranulocytosis
• Postmarketing reports: Hemolysis (in glucose-6-phosphate dehydrogenase deficient patients)^[Ref]

Other

• Very rare (less than 0.01%): Weight decreased/loss, fatigue/lassitude^[Ref]

Respiratory

• Postmarketing reports: Bronchospasm^[Ref]

Hypersensitivity

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

See also:

Frequently asked questions

• An Update: Is hydroxychloroquine effective for COVID-19?
• Does hydroxychloroquine cause emotional lability?

Further information

Sovuna side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer