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What the FDA labels say about taking them together

Hydroxychloroquine and methotrexate

Hydroxychloroquine's FDA label of October 8, 2024 names methotrexate in its drug interactions section, and methotrexate's label names hydroxychloroquine too. The hydroxychloroquine label: “Concomitant use of SOVUNA and methotrexate may increase the incidence of adverse reactions.”

Check it at the source: the hydroxychloroquine FDA label on DailyMed (effective October 8, 2024, ANI Pharmaceuticals, Inc.); the methotrexate FDA label on DailyMed (effective May 27, 2026, Accord Healthcare Inc.).

What does the hydroxychloroquine label say about methotrexate?

Hydroxychloroquine label, drug interactions

Concomitant use of SOVUNA and methotrexate may increase the incidence of adverse reactions.

Source: FDA drug label (Plaquenil, NDA009768), Advanz Pharma (US) Corp., effective April 9, 2026 (SPL set 34496b43-05a2-45fb-a769-52b12e099341), via openFDA

Source: FDA drug label (SOVUNA), ANI Pharmaceuticals, Inc., effective October 8, 2024 (SPL set dd441154-b196-4d4c-bc56-2e37f345ef8d), via openFDA; the full label on DailyMed

What does the methotrexate label say about hydroxychloroquine?

Rasuvo label (Medexus Pharma Inc., December 15, 2025), drug interactions

Combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine, or cytotoxic agents, has not been studied and may increase the incidence of adverse effects.

Source: FDA drug label (Rasuvo, NDA205776), Medexus Pharma Inc., effective December 15, 2025 (SPL set d0075461-0e7e-4967-9c9b-d6440e912c0e), via openFDA

Source: FDA drug label (Methotrexate), Accord Healthcare Inc., effective May 27, 2026 (SPL set 874c7f43-a3be-4236-89cc-24c44e3c5813), via openFDA; the full label on DailyMed

These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.

Both medicines on the record

28Hydroxychloroquine generic labelers
29Methotrexate generic labelers
HydroxychloroquineMethotrexate
Labeled forRheumatoid arthritisRheumatoid arthritis, Psoriasis, Leukemia, lymphoma and myeloma, Breast cancer
Boxed warningNoYes
Pharmacy cost (NADAC)$0.149 per tablet 200 mg tablet$0.158 per tablet 2.5 mg tablet
Shortage nowA presentation being discontinuedIn shortage

Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)

What next?