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What the FDA labels say about taking them together

Nilutamide and theophylline

Nilutamide's FDA label of June 26, 2026 names theophylline in its drug interactions section; the theophylline label PlainMeds reads does not name nilutamide. The nilutamide label: “Consequently, drugs with a low therapeutic margin, such as vitamin K antagonists, phenytoin, and theophylline, could have a delayed elimination and increases in their serum half-life leading to a toxic level.”

Check it at the source: the nilutamide FDA label on DailyMed (effective June 26, 2026, ANI Pharmaceuticals, Inc.); the theophylline FDA label on DailyMed (effective March 10, 2026, Strides Pharma Science Limited).

What does the nilutamide label say about theophylline?

Nilutamide label, drug interactions

Consequently, drugs with a low therapeutic margin, such as vitamin K antagonists, phenytoin, and theophylline, could have a delayed elimination and increases in their serum half-life leading to a toxic level.

Source: FDA drug label (Nilutamide), ANDA207631 (Ani Pharms), as published by ANI Pharmaceuticals, Inc., effective June 26, 2026 (SPL set d5740b8f-fbb3-4023-9133-9e359a9ab980), via openFDA; the full label on DailyMed

What does the theophylline label say about nilutamide?

Theophylline's label (effective March 10, 2026) does not name nilutamide in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (Theophylline), Strides Pharma Science Limited, effective March 10, 2026 (SPL set b7a90ccf-9c32-40cc-9008-7e55b3da4dfd), 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

1Nilutamide generic labelers
26Theophylline generic labelers
NilutamideTheophylline
Labeled forProstate cancerAsthma
Boxed warningYesNo
Pharmacy cost (NADAC)n/a$0.330 per tablet 300 mg tablet
Shortage nowA presentation being discontinuedNo 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?