Is Hydroxychloroquine Safe in Pregnancy
Status
cautionReason
Official labeling does not show a clear birth-defect risk, but pregnancy use should be reviewed with a prescriber.
Drug Information
Safe Amount
Dosage must be determined by your provider based on individual risk/benefit.
Effects
- Pregnancy
- Use needs individual risk-benefit review. Do not stop or start without a prescriber.
- Mother
- May help control malaria, lupus, or rheumatoid arthritis during pregnancy; untreated disease can also harm mother and pregnancy.
- Baby
- Placenta crossing occurs; official data have not established a link to major birth defects or miscarriage.
Trimester Notes
- 1st Trimester
- First-trimester exposure has not been linked in official labeling to major birth defects, but review with your prescriber is still needed.
- 2nd Trimester
- No special second-trimester warning in official labeling. Use only with provider guidance based on disease control and pregnancy needs.
- 3rd Trimester
- No trimester-specific dosing is given in official labeling. Continue only if your prescriber says the benefit outweighs the risk.
Risk-Benefit Note
For lupus, rheumatoid arthritis, and malaria, untreated or active disease can raise pregnancy risks. Provider review is needed before changing therapy.
Conditions & Warnings
- Consult OB/GYN or prescriber
- If used for malaria, follow the exact regimen your provider gives
- If used for lupus or rheumatoid arthritis, provider review before stopping or continuing
- Pregnancy dosing should be determined by your provider
Alternatives
- Discuss pregnancy-safe options with your OB/GYN or prescriber
- For malaria prevention or treatment, ask your clinician about pregnancy-appropriate regimens
- For lupus or rheumatoid arthritis, ask about the safest disease-control plan for pregnancy
References
- FDA hydroxychloroquine sulfate tablets label
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214581s000lbl.pdf - FDA hydroxychloroquine sulfate EUA fact sheet for healthcare providers
https://www.fda.gov/media/136537/download