Is Hydroxychloroquine Safe in Pregnancy

Status

caution Last reviewed: 2026-05-16 · Confidence: moderate

Reason

Official labeling does not show a clear birth-defect risk, but pregnancy use should be reviewed with a prescriber.

Drug Information

Brand Name
Plaquenil
Generic Name
hydroxychloroquine
Drug Class
Antimalarial; disease-modifying antirheumatic drug (DMARD)
FDA Category
N/A (PLLR narrative label)
Rx Status
prescription

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

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