Skip to main content

What the FDA labels say about taking them together

Cyclophosphamide and golimumab

Golimumab's FDA label of September 9, 2025 names cyclophosphamide in its warnings and precautions section; the cyclophosphamide labels PlainMeds reads (4) do not name golimumab. The golimumab label: “In controlled trials of other TNF-blockers in patients at higher risk for malignancies a greater portion of malignancies occurred in the TNF-blocker group compared to the controlled group.”

Check it at the source: the cyclophosphamide FDA label on DailyMed (effective January 19, 2026, Amneal Pharmaceuticals LLC); the golimumab FDA label on DailyMed (effective September 9, 2025, Janssen Biotech, Inc.).

What does the cyclophosphamide label say about golimumab?

Cyclophosphamide's label (effective January 19, 2026) and its 3 other brand-application labels do not name golimumab in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (Cyclophosphamide), Amneal Pharmaceuticals LLC, effective January 19, 2026 (SPL set 520bfe39-dfd5-4a20-9a37-80078afded0d), via openFDA; the full label on DailyMed

What does the golimumab label say about cyclophosphamide?

Golimumab label, warnings and precautions

In controlled trials of other TNF-blockers in patients at higher risk for malignancies (e.g., patients with chronic obstructive pulmonary disease [COPD], patients with Wegener's granulomatosis treated with concomitant cyclophosphamide) a greater portion of malignancies occurred in the TNF-blocker group compared to the controlled group.

Source: FDA drug label (SIMPONI ARIA), Janssen Biotech, Inc., effective September 9, 2025 (SPL set 9e260a47-55af-4c92-8d88-a86ccc767fff), 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

19Cyclophosphamide generic labelers
0Golimumab generic labelers
CyclophosphamideGolimumab
Labeled forLeukemia, lymphoma and myelomaRheumatoid arthritis, Crohn's disease and ulcerative colitis
Boxed warningNoYes
Pharmacy cost (NADAC)$1.67 per capsule 50 mg capsule$12,890.32 per mL 50 mg/0.5 mL pen injec
Shortage nowNo current entryNo current entry

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

What next?