No black box warning on record for Hydroxychloroquine

As of the latest FDA labeling reviewed, Hydroxychloroquine (hydroxychloroquine sulfate) does not carry a black box warning. Standard warnings and precautions still apply — see the full Hydroxychloroquine medicine page for the complete safety profile.

Other warnings & precautions

Retinal Toxicity — Annual Eye Exams Mandatory: Hydroxychloroquine accumulates in the retinal pigment epithelium and can cause irreversible maculopathy ('bull's-eye' pattern), leading to permanent visual field loss or central vision loss. Risk is dose-dependent and cumulative over time (low risk in first 5 years at ≤5mg/kg/day; increases significantly after 10 years). American Academy of Ophthalmology recommends baseline eye exam within the first year of use, then annual screening after 5 years of use (earlier if high risk factors). High-risk factors: dose >5mg/kg/day, renal impairment, concurrent tamoxifen use, pre-existing retinal disease.
Dose Limitation — 5mg/kg/day MAX: Never exceed 5mg/kg/day based on actual (not ideal) body weight. Use of doses exceeding this threshold dramatically increases retinal toxicity risk. In obese patients, use actual body weight (not ideal body weight) for this calculation.
QTc Prolongation and Cardiac Toxicity: Hydroxychloroquine prolongs the QT interval. Risk is greatest when combined with other QTc-prolonging medicines. This became highly relevant during the COVID-19 pandemic when combination with azithromycin caused cardiac deaths. Obtain baseline ECG in high-risk patients.
G6PD Deficiency: Hydroxychloroquine can cause hemolytic anemia in G6PD-deficient patients. Test for G6PD deficiency before initiating therapy in high-risk populations (Mediterranean, African, Asian ancestry).
Pregnancy Safety Nuance: Despite being Category C, hydroxychloroquine is considered relatively safe in pregnancy for autoimmune indications (rheumatoid arthritis, SLE) and is often continued throughout pregnancy to prevent SLE flares. Discontinuing hydroxychloroquine during pregnancy in lupus patients increases flare risk, which is more dangerous than the medicine. Discuss risk-benefit with rheumatologist.

Other warnings & precautions

Retinal Toxicity — Annual Eye Exams Mandatory: Hydroxychloroquine accumulates in the retinal pigment epithelium and can cause irreversible maculopathy ('bull's-eye' pattern), leading to permanent visual field loss or central vision loss. Risk is dose-dependent and cumulative over time (low risk in first 5 years at ≤5mg/kg/day; increases significantly after 10 years). American Academy of Ophthalmology recommends baseline eye exam within the first year of use, then annual screening after 5 years of use (earlier if high risk factors). High-risk factors: dose >5mg/kg/day, renal impairment, concurrent tamoxifen use, pre-existing retinal disease.

Dose Limitation — 5mg/kg/day MAX: Never exceed 5mg/kg/day based on actual (not ideal) body weight. Use of doses exceeding this threshold dramatically increases retinal toxicity risk. In obese patients, use actual body weight (not ideal body weight) for this calculation.

QTc Prolongation and Cardiac Toxicity: Hydroxychloroquine prolongs the QT interval. Risk is greatest when combined with other QTc-prolonging medicines. This became highly relevant during the COVID-19 pandemic when combination with azithromycin caused cardiac deaths. Obtain baseline ECG in high-risk patients.

G6PD Deficiency: Hydroxychloroquine can cause hemolytic anemia in G6PD-deficient patients. Test for G6PD deficiency before initiating therapy in high-risk populations (Mediterranean, African, Asian ancestry).

Pregnancy Safety Nuance: Despite being Category C, hydroxychloroquine is considered relatively safe in pregnancy for autoimmune indications (rheumatoid arthritis, SLE) and is often continued throughout pregnancy to prevent SLE flares. Discontinuing hydroxychloroquine during pregnancy in lupus patients increases flare risk, which is more dangerous than the medicine. Discuss risk-benefit with rheumatologist.

Hydroxychloroquine Black Box Warning

No black box warning on record for Hydroxychloroquine

Other warnings & precautions

Hydroxychloroquine Black Box Warning

No black box warning on record for Hydroxychloroquine

Other warnings & precautions