Hydroxychloroquine Safety Profile

Key Safety Advantages

• Hydroxychloroquine is generally believed to be safe with limited serious adverse effects when used at appropriate doses, with most side effects reversing with discontinuation of therapy, and has been used safely in children for rheumatologic diseases for many years 1, 2, 3, 4, 5.
• The American College of Chest Physicians recommends hydroxychloroquine as a safe option for patients with rheumatoid arthritis, with a favorable toxicity profile and established safety record, including use in pregnancy 1, 2, 3.

Pregnancy Safety

• Hydroxychloroquine is safe during pregnancy if clinically indicated, with 133 pregnancies resulting in 117 live births showing no difference in complications compared to untreated patients, according to the American College of Obstetricians and Gynecologists 1, 2, 3.

Retinal Toxicity Risk

• The primary serious toxicity of hydroxychloroquine is irreversible retinopathy, but the risk is <1% in the first 5 years and <2% up to 10 years when dosed at ≤5.0 mg/kg real body weight, and toxicity is dose-dependent and largely preventable with proper dosing and monitoring 6.
• The American Academy of Ophthalmology recommends ophthalmologic screening every 6-12 months for patients taking hydroxychloroquine 1, 2, 3.

Monitoring Requirements

• The American Heart Association recommends ECG monitoring if using hydroxychloroquine with other QT-prolonging drugs 7.
• The National Kidney Foundation recommends using real body weight for hydroxychloroquine dosing calculations, keeping daily dose <5.0 mg/kg, to minimize toxicity risk 6.