Prescription medicine
Theophylline Brand names: Theo
Theophylline (Theo) is a prescription medicine with an FDA approval on record since 1982. FDA's NDC Directory lists it from 26 generic labelers, and pharmacies paid $0.330 per theophylline ER 300 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $3.82 per Theo-24 ER 100 mg capsule.
- Generic listed
Check it at the source: the theophylline FDA label on DailyMed (effective March 10, 2026, Strides Pharma Science Limited); the NDA 18649 record on Drugs@FDA; every theophylline label on DailyMed.
Highlights of the record
FDA label of March 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTheophylline 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.
Forms and strengths
- 100 mg
- 200 mg
- 300 mg
- 400 mg
- 450 mg
- 600 mg
- 80 mg/15ml
Extended-release tablet; solution; extended-release capsule.
On the market
- Earliest approval on file
- July 26, 1982 Theophylline And Dextrose 5% In Plastic Container, Baxter Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 87 first July 26, 1976; 20 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 26 of which 26 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.330 per tablet Theophylline ER 300 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2020 0 Class I among all firms' recalls; latest August 8, 2025
- FAERS reports
- 12,327 through July 30, 2026
What is theophylline used for?
From the label: indications and usageTheophylline 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.
Conditions named in the indications of theophylline's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Methylxanthine.
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
Is there a generic for theophylline (Theo)?
The FDA approved the first generic theophylline on July 26, 1976. 87 generic applications are approved; 20 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists theophylline from 26 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1982 earliest approval on file
- 1976 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for theophylline (Theo)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.330 per Theophylline ER 300 mg tablet, down 33% from $0.492 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Theophylline ER 300 mg tablet (generic)
- Theo-24 ER 100 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Theophylline 80 mg/15 mL solution | Generic | $0.112 per mL | n/a | +3% |
| Theophylline ER 300 mg tablet | Generic | $0.330 per tablet | $9.89 | -33% |
| Theophylline ER 400 mg tablet | Generic | $0.995 per tablet | $29.86 | +19% |
| Theophylline ER 450 mg tablet | Generic | $1.10 per tablet | $32.98 | +18% |
| Theophylline ER 600 mg tablet | Generic | $1.40 per tablet | $41.85 | +14% |
| Theo-24 ER 100 mg capsule | Brand | $3.82 per capsule | $114.48 | +2% |
| Theo-24 ER 200 mg capsule | Brand | $5.67 per capsule | $170.03 | +3% |
| Theo-24 ER 300 mg capsule | Brand | $6.95 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $208.59 | +3% |
| Theo-24 ER 400 mg capsule | Brand | $9.79 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $293.80 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has theophylline been recalled?
The FDA's Enforcement Report lists 4 recalls naming theophylline since 2020: 0 Class I (the most serious), 4 Class II, 0 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 8, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term … |
| May 15, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | OOS results reported for the Dissolution (by UV) test. |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| March 6, 2020 | Class II | Nostrum Laboratories Inc | CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the theophylline label say about other medicines?
The theophylline label names 61 other medicines in its interaction, contraindication or warning sections. The labels of 40 other medicines name theophylline. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Adenosine | drug interactions | Higher doses of adenosine may be required to achieve desired effect. |
| Albuterol | drug interactions | albuterol, systemic and inhaled; mebendazole |
| Allopurinol | drug interactions | 30% increase Allopurinol Decreases theophylline clearance at allopurinol doses ≥600 mg/day. |
| Amoxicillin | drug interactions | amoxicillin; medroxyprogesterone |
| Atenolol | drug interactions | atenolol; metoprolol |
| Azithromycin | drug interactions | azithromycin; nadolol |
| Caffeine | drug interactions | caffeine, dietary ingestion; nifedipine |
| Carbamazepine | drug interactions | 25% decrease Carbamazepine Similar to aminoglutethimide. |
| Cefaclor | drug interactions | cefaclor; nizatidine |
| Cefazolin | drug interactions | Some drugs (e.g., cefazolin, cephalothin), however, may interfere with certain HPLC techniques. |
| Cimetidine | drug interactions | Drug: Cimetidine; Type of Interaction: Decreases theophylline clearance by inhibiting cytochrome P450 1A2.; Effect**: 70% increase |
| Ciprofloxacin | drug interactions | 70% increase Ciprofloxacin Similar to cimetidine. |
| Clarithromycin | drug interactions | 40% increase Clarithromycin Similar to erythromycin. |
| Diazepam | drug interactions | 25% increase Diazepam Benzodiazepines increase CNS concentrations of adenosine, a potent CNS depressant, while theophylline blocks adenosine receptors. |
Every other medicine the theophylline label names
| Medicine named | Section | What the label says |
|---|---|---|
| Diltiazem | drug interactions | diltiazem; omeprazole |
| Disulfiram | drug interactions | Disulfiram Decreases theophylline clearance by inhibiting hydroxylation and demethylation. |
| Ephedrine | drug interactions | 300% increase Ephedrine Synergistic CNS effects. Increased frequency of nausea, nervousness, and insomnia. |
| Erythromycin | drug interactions | Drug: Clarithromycin; Type of Interaction: Similar to erythromycin.; Effect**: 25% increase |
| Famotidine | drug interactions | famotidine; rifabutin |
| Felodipine | drug interactions | felodipine; roxithromycin |
| Finasteride | drug interactions | finasteride; Sorbitol (purgative doses do not inhibit |
| Flurazepam | drug interactions | 30% increase Flurazepam Similar to diazepam. |
| Fluvoxamine | drug interactions | Fluvoxamine Similar to cimetidine. |
| Hydrocortisone | drug interactions | hydrocortisone; theophylline absorption) |
| Isoflurane | drug interactions | isoflurane; sucralfate |
| Isoniazid | drug interactions | isoniazid; terbutaline, systemic |
| Isoproterenol | drug interactions | 100% increase Isoproterenol (IV) Increases theophylline clearance. |
| Isradipine | drug interactions | isradipine; terfenadine |
| Ketamine | drug interactions | 20% decrease Ketamine Pharmacologic. |
| Ketoconazole | drug interactions | ketoconazole; tocainide |
| Lithium | drug interactions | May lower theophylline seizure threshold Lithium Theophylline increases renal lithium clearance. |
| Lorazepam | drug interactions | Lorazepam Similar to diazepam. |
| Mebendazole | drug interactions | albuterol, systemic and inhaled; mebendazole |
| Medroxyprogesterone | drug interactions | amoxicillin; medroxyprogesterone |
| Methotrexate | drug interactions | Methotrexate (MTX) Decreases theophylline clearance. |
| Methylprednisolone | drug interactions | ampicilin, with or without; methylprednisolone |
| Metoprolol | drug interactions | atenolol; metoprolol |
| Metronidazole | drug interactions | sulbactam; metronidazole |
| Mexiletine | drug interactions | Mexiletine Similar to disulfiram. |
| Midazolam | drug interactions | 80% increase Midazolam Similar to diazepam. |
| Nadolol | drug interactions | azithromycin; nadolol |
| Nifedipine | drug interactions | caffeine, dietary ingestion; nifedipine |
| Nizatidine | drug interactions | cefaclor; nizatidine |
| Ofloxacin | drug interactions | co-trimoxazole (trimethoprim and sulfamethoxazole); ofloxacin |
| Omeprazole | drug interactions | diltiazem; omeprazole |
| Pentoxifylline | drug interactions | Pentoxifylline Decreases theophylline clearance. |
| Phenobarbital | drug interactions | 30% increase Phenobarbital (PB) Similar to aminoglutethimide. |
| Phenytoin | drug interactions | Phenytoin Phenytoin increases theophylline clearance by increasing microsomal enzyme activity. |
| Prednisolone | drug interactions | dirithromycin; prednisone, prednisolone |
| Prednisone | drug interactions | dirithromycin; prednisone, prednisolone |
| Progesterone | drug interactions | The effect of progesterone on theophylline clearance is unknown. |
| Propafenone | drug interactions | Serum theophylline and phenytoin concentrations decrease about 40%. Propafenone Decreases theophylline clearance and pharmacologic interaction. |
| Propranolol | drug interactions | Beta-2 blocking effect may decrease efficacy of theophylline. Propranolol Similar to cimetidine and pharmacologic interaction. |
| Ranitidine | drug interactions | enflurane; ranitidine |
| Rifabutin | drug interactions | famotidine; rifabutin |
| Rifampin | drug interactions | Drug: Rifampin; Type of Interaction: Increases theophylline clearance by increasing cytochrome P450 1A2 and 3A3 activity.; Effect**: 20 to 40% decrease |
| Sucralfate | drug interactions | isoflurane; sucralfate |
| Terbutaline | drug interactions | isoniazid; terbutaline, systemic |
| Tetracycline | drug interactions | influenza vaccine; tetracycline |
| Trimethoprim | drug interactions | co-trimoxazole (trimethoprim and sulfamethoxazole); norfloxacin |
| Verapamil | drug interactions | Verapamil Similar to disulfiram. |
Other labels that name theophylline
- Adalimumab
- Albendazole
- Aminophylline
- Arformoterol
- Bupropion
- Cannabidiol
- Deferasirox
- Dichlorphenamide
- Doxapram
- Drospirenone and ethinyl estradiol
- Drospirenone and ethinyl estradiol and levomefolate
- Epinephrine
- Ethinyl estradiol and etonogestrel
- Ethinyl estradiol and ferrous bisglycinate and levonorgestrel
- Ethinyl estradiol and ferrous fumarate and levonorgestrel
- Ethinyl estradiol and levonorgestrel
- Ethinyl estradiol and norelgestromin
- Ethinyl estradiol and norgestimate
- Ethinyl estradiol and segesterone
- Fluconazole
- Golimumab
- Histamine
- Infliximab
- Lansoprazole
- Leflunomide
- Levocetirizine
- Levothyroxine
- Methacholine
- Methimazole
- Metreleptin
- Nicotine
- Nilutamide
- Osilodrostat
- Paroxetine
- Peginterferon alfa 2a
- Pralidoxime
- Primaquine
- Propylthiouracil
- Riociguat
- Ritonavir
- Sarilumab
- Siltuximab
- Stiripentol
- Tamsulosin
- Teriflunomide
- Tocilizumab
- Varenicline
- Zileuton
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
What do FAERS reports show for theophylline?
The FDA Adverse Event Reporting System holds 12,327 reports that list theophylline among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,787 are coded as a death and 5,350 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as theophylline?
9 other medicines are given the same way (oral) and in the same FDA class as theophylline or labeled mainly for the same use (asthma), the same class first. Asthma lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Dexamethasone | Asthma | 41 labelers | $0.193 per tablet 4 mg tablet | In shortage |
| Montelukast | Asthma | 36 labelers | $0.0419 per tablet 10 mg tablet | A presentation being discontinued |
| Albuterol | Asthma | 14 labelers | $0.288 per tablet 2 mg tablet | Resolved |
| Budesonide | Asthma | 14 labelers | $0.498 per capsule 3 mg capsule | No current entry |
| Zafirlukast | Asthma | 5 labelers | $0.623 per tablet 20 mg tablet | No current entry |
| Zileuton | Asthma | 5 labelers | $2.05 per tablet 600 mg tablet | No current entry |
| Ephedrine | Asthma | none listed | n/a | No current entry |
| Cromolyn | Asthma | 3 labelers | $0.349 per mL 100 mg/5 mL oral conc | Listed; available |
Every medicine labeled for the same conditions as theophylline
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does theophylline compare with medicines for the same use?
1 side-by-side page set theophylline beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to theophylline
- 9 medicines for the same use
- Other methylxanthines
- the pharmacologic class, with prices and generics
- Theophylline side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other