Two medicines, side by side
Febuxostat vs theophylline
Febuxostat is labeled for gout; theophylline for asthma. Their labels share no use, so they are not alternatives to each other. Drugs@FDA records approvals of febuxostat since 2009 and of theophylline since 1982. Pharmacies paid $0.191 per febuxostat 40 mg tablet and $0.330 per theophylline ER 300 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. Theophylline's other strengths are brand-only: $3.82 per Theo-24 ER 100 mg capsule. In FDA's classes, febuxostat is a xanthine oxidase inhibitor and theophylline a methylxanthine.
Check it at the source: the febuxostat FDA label on DailyMed (effective December 24, 2025); the theophylline FDA label on DailyMed (effective March 10, 2026).
Highlights of the febuxostat record
Febuxostat (Uloric) · label of December 24, 2025
CARDIOVASCULAR DEATH Gout patients with established cardiovascular (CV) disease treated with ULORIC had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study [see Warnings and Precautions (5.1) ]. Consider the risks and benefits of ULORIC when deciding to prescribe or continue patients on ULORIC.
Used for
From the label: indicationsULORIC is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. […]
On the market
- Earliest approval on file
- February 13, 2009
- Generic labelers
- 23 labelers
- Pharmacy cost
- $0.191 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 5
Highlights of the theophylline record
Theophylline (Theo) · label of March 10, 2026
Used for
From the label: indicationsTheophylline extended-release tablets are indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.
On the market
- Earliest approval on file
- July 26, 1982
- Generic labelers
- 26 labelers
- Pharmacy cost
- $0.330 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 4
Source: FDA drug labels via openFDA (Febuxostat label of December 24, 2025, Theophylline label of March 10, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do febuxostat and theophylline differ on the record?
In FDA's classes, febuxostat is a xanthine oxidase inhibitor and theophylline a methylxanthine.
How each works, in its label's words: Febuxostat, “ULORIC, a xanthine oxidase inhibitor, achieves its therapeutic effect by decreasing serum uric acid.”; Theophylline, “Mechanism of Action: Theophylline has two distinct actions in the airways of patients with reversible obstruction; smooth muscle relaxation (i.e., bronchodilation) and suppression of the response of …”
Half-life, in each label's words: Febuxostat, “Febuxostat has an apparent mean terminal elimination half-life (t 1/2 ) of approximately 5 to 8 hours.”; Theophylline, “At steady-state, on a dosage regimen with 6-hour intervals, the expected mean trough concentration is approximately 60% …”
Only the febuxostat label carries a boxed warning.
Generics: febuxostat since 2019; theophylline since 1976 (Drugs@FDA).
| Febuxostat | Theophylline | |
|---|---|---|
| Labeled for | Gout | Asthma |
| Pharmacologic class | Xanthine Oxidase Inhibitor | Methylxanthine |
| How it works (label) | ULORIC, a xanthine oxidase inhibitor, achieves its therapeutic effect by decreasing serum uric acid. ULORIC is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations. | Mechanism of Action: Theophylline has two distinct actions in the airways of patients with reversible obstruction; smooth muscle relaxation (i.e., bronchodilation) and suppression of the response of the airways to stimuli (i.e. … |
| Half-life (label) | Febuxostat has an apparent mean terminal elimination half-life (t 1/2 ) of approximately 5 to 8 hours. | At steady-state, on a dosage regimen with 6-hour intervals, the expected mean trough concentration is approximately 60% of the mean peak concentration, assuming a mean theophylline half-life of 8 hours. |
| Earliest approval on file (Drugs@FDA) | February 13, 2009 | July 26, 1982 |
| First generic approved | July 1, 2019 | July 26, 1976 |
| Generic labelers (NDC) | 23 labelers | 26 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.191 per tablet (Febuxostat 40 mg tablet) | $0.330 per tablet (Theophylline ER 300 mg tablet) |
| 12-month price change | -19% | -33% |
| Boxed warning | Yes | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 5 | 4 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 16,668 | 12,327 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
Do their labels mention each other?
Febuxostat label, drug interactionsBased on a drug interaction study in healthy patients, febuxostat altered the metabolism of theophylline (a substrate of XO) in humans [see Clinical Pharmacology (12.3) ].
Source: FDA drug labels via openFDA
What next?
- Alternatives to febuxostat
- every medicine labeled for the same conditions