Prescription medicine
Aminophylline First approved as Aminophyllin
Aminophylline (Aminophyllin) is a prescription medicine with an FDA approval on record since 1940. FDA's NDC Directory lists it from 5 generic labelers.
- Generic listed
Check it at the source: the aminophylline FDA label on DailyMed (effective May 22, 2026, Hospira, Inc.); the NDA 2386 record on Drugs@FDA; every aminophylline label on DailyMed.
Highlights of the record
FDA label of May 22, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageIntravenous theophylline is indicated as an adjunct to inhaled beta-2 selective agonists and systemically administered corticosteroids for the treatment of acute exacerbations of the symptoms and reversible airflow obstruction associated with asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.
Forms and strengths
- 25 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- April 19, 1940 Aminophyllin, Gd Searle Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 34 first November 26, 1975; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 5 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2012 0 Class I among all firms' recalls; latest September 27, 2022; 3 more by firms not listed as its makers
- FAERS reports
- 1,970 through July 30, 2026
What is aminophylline used for?
From the label: indications and usageIntravenous theophylline is indicated as an adjunct to inhaled beta-2 selective agonists and systemically administered corticosteroids for the treatment of acute exacerbations of the symptoms and reversible airflow obstruction associated with asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.
Conditions named in the indications of aminophylline's FDA labels, with every medicine labeled for each:
From other aminophylline labelsAsthma: … exacerbations of the symptoms and reversible airflow obstruction associated with asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.
FDA pharmacologic class: Methylxanthine.
Source: FDA drug label (Aminophylline), Hospira, Inc., effective May 22, 2026 (SPL set 9a663ef3-881f-48bd-2689-3713b24545c2), via openFDA; the full label on DailyMed
Is there a generic for aminophylline (Aminophyllin)?
The FDA approved the first generic aminophylline on November 26, 1975. 34 generic applications are approved; 1 of them carries 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 aminophylline from 5 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.
- 1940 earliest approval on file
- 1975 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has aminophylline been recalled?
The FDA's Enforcement Report lists 4 recalls naming aminophylline since 2012: 0 Class I (the most serious), 4 Class II, 0 Class III; 0 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of aminophylline and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 27, 2022 | Class II | Pfizer Inc. | Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial. |
| May 28, 2013 | Class II | Main Street Family Pharmacy, LLC not a listed maker | The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone … |
| May 25, 2012 | Class II | Franck's Lab Inc., d.b.a. Franck's Compounding Lab not a listed maker | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the aminophylline label say about other medicines?
The aminophylline label names 63 other medicines in its interaction, contraindication or warning sections. The labels of 11 other medicines name aminophylline. 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 amoxicillin ampicillin, with or without sulbactam atenolol azithromycin caffeine, dietary ingestion cefaclor co-trimoxazole (trimethoprim and sulfamethoxazole) diltiazem dirithromycin enflurane famotidine felodipine finasteride hydrocortisone isoflurane isoniazid isradipine influenza … |
| Allopurinol | drug interactions | 30% increase Allopurinol Decreases theophylline clearance at allopurinol doses ≥600 mg/day. |
| Amoxicillin | drug interactions | albuterol, systemic and inhaled amoxicillin ampicillin, with or without sulbactam atenolol azithromycin caffeine, dietary ingestion cefaclor co-trimoxazole (trimethoprim and sulfamethoxazole) diltiazem dirithromycin enflurane famotidine felodipine finasteride hydrocortisone isoflurane isoniazid isradipine influenza … |
| Ampicillin | drug interactions | albuterol, systemic and inhaled amoxicillin ampicillin, with or without sulbactam atenolol azithromycin caffeine, dietary ingestion cefaclor co-trimoxazole (trimethoprim and sulfamethoxazole) diltiazem dirithromycin enflurane famotidine felodipine finasteride hydrocortisone isoflurane isoniazid isradipine influenza … |
| Atenolol | drug interactions | albuterol, systemic and inhaled amoxicillin ampicillin, with or without sulbactam atenolol azithromycin caffeine, dietary ingestion cefaclor co-trimoxazole (trimethoprim and sulfamethoxazole) diltiazem dirithromycin enflurane famotidine felodipine finasteride hydrocortisone isoflurane isoniazid isradipine influenza … |
| Azithromycin | drug interactions | albuterol, systemic and inhaled amoxicillin ampicillin, with or without sulbactam atenolol azithromycin caffeine, dietary ingestion cefaclor co-trimoxazole (trimethoprim and sulfamethoxazole) diltiazem dirithromycin enflurane famotidine felodipine finasteride hydrocortisone isoflurane isoniazid isradipine influenza … |
| Caffeine | drug interactions | albuterol, systemic and inhaled amoxicillin ampicillin, with or without sulbactam atenolol azithromycin caffeine, dietary ingestion cefaclor co-trimoxazole (trimethoprim and sulfamethoxazole) diltiazem dirithromycin enflurane famotidine felodipine finasteride hydrocortisone isoflurane isoniazid isradipine influenza … |
| Carbamazepine | drug interactions | 25% decrease Carbamazepine Similar to aminoglutethimide. |
| Cefaclor | drug interactions | albuterol, systemic and inhaled amoxicillin ampicillin, with or without sulbactam atenolol azithromycin caffeine, dietary ingestion cefaclor co-trimoxazole (trimethoprim and sulfamethoxazole) diltiazem dirithromycin enflurane famotidine felodipine finasteride hydrocortisone isoflurane isoniazid isradipine influenza … |
| 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. |
Every other medicine the aminophylline label names
| Medicine named | Section | What the label says |
|---|---|---|
| Diazepam | drug interactions | 25% increase Diazepam Benzodiazepines increase CNS concentrations of adenosine, a potent CNS depressant, while theophylline blocks adenosine receptors. |
| Diltiazem | drug interactions | … ingestion cefaclor co-trimoxazole (trimethoprim and sulfamethoxazole) diltiazem dirithromycin enflurane famotidine felodipine finasteride hydrocortisone isoflurane isoniazid isradipine influenza … |
| 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 | … (trimethoprim and sulfamethoxazole) diltiazem dirithromycin enflurane famotidine felodipine finasteride hydrocortisone isoflurane isoniazid isradipine influenza vaccine ketoconazole; … |
| Felodipine | drug interactions | … and sulfamethoxazole) diltiazem dirithromycin enflurane famotidine felodipine finasteride hydrocortisone isoflurane isoniazid isradipine influenza vaccine ketoconazole; … |
| Finasteride | drug interactions | … sulfamethoxazole) diltiazem dirithromycin enflurane famotidine felodipine finasteride hydrocortisone isoflurane isoniazid isradipine influenza vaccine ketoconazole; … |
| Flurazepam | drug interactions | 30% increase Flurazepam Similar to diazepam. |
| Fluvoxamine | drug interactions | Fluvoxamine Similar to cimetidine. |
| Hydrocortisone | drug interactions | … diltiazem dirithromycin enflurane famotidine felodipine finasteride hydrocortisone isoflurane isoniazid isradipine influenza vaccine ketoconazole; … |
| Isoflurane | drug interactions | … dirithromycin enflurane famotidine felodipine finasteride hydrocortisone isoflurane isoniazid isradipine influenza vaccine ketoconazole; … |
| Isoniazid | drug interactions | … enflurane famotidine felodipine finasteride hydrocortisone isoflurane isoniazid isradipine influenza vaccine ketoconazole; … |
| Isoproterenol | drug interactions | 100% increase Isoproterenol (I.V.) Increases theophylline clearance. |
| Isradipine | drug interactions | … famotidine felodipine finasteride hydrocortisone isoflurane isoniazid isradipine influenza vaccine ketoconazole; lomefloxacin mebendazole medroxyprogesterone methylprednisolone metronidazole … |
| Ketamine | drug interactions | 20% decrease Ketamine Pharmacologic May lower theophylline seizure threshold. |
| Ketoconazole | drug interactions | … finasteride hydrocortisone isoflurane isoniazid isradipine influenza vaccine ketoconazole; lomefloxacin mebendazole medroxyprogesterone methylprednisolone metronidazole metoprolol nadolol nifedipine … |
| Lithium | drug interactions | Lithium Theophylline increases renal lithium clearance. |
| Lorazepam | drug interactions | Lorazepam Similar to diazepam. |
| Mebendazole | drug interactions | … isoniazid isradipine influenza vaccine ketoconazole; lomefloxacin mebendazole medroxyprogesterone methylprednisolone metronidazole metoprolol nadolol nifedipine nizatidine norfloxacin ofloxacin … |
| Medroxyprogesterone | drug interactions | … isradipine influenza vaccine ketoconazole; lomefloxacin mebendazole medroxyprogesterone methylprednisolone metronidazole metoprolol nadolol nifedipine nizatidine norfloxacin ofloxacin omeprazole … |
| Methotrexate | drug interactions | Methotrexate (MTX) Decreases theophylline clearance. |
| Methylprednisolone | drug interactions | … vaccine ketoconazole; lomefloxacin mebendazole medroxyprogesterone methylprednisolone metronidazole metoprolol nadolol nifedipine nizatidine norfloxacin ofloxacin omeprazole prednisone, prednisolone … |
| Metoprolol | drug interactions | … lomefloxacin mebendazole medroxyprogesterone methylprednisolone metronidazole metoprolol nadolol nifedipine nizatidine norfloxacin ofloxacin omeprazole prednisone, prednisolone ranitidine rifabutin … |
| Metronidazole | drug interactions | … ketoconazole; lomefloxacin mebendazole medroxyprogesterone methylprednisolone metronidazole metoprolol nadolol nifedipine nizatidine norfloxacin ofloxacin omeprazole prednisone, prednisolone … |
| Mexiletine | drug interactions | Mexiletine Similar to disulfiram. |
| Midazolam | drug interactions | 80% increase Midazolam Similar to diazepam. |
| Nadolol | drug interactions | … mebendazole medroxyprogesterone methylprednisolone metronidazole metoprolol nadolol nifedipine nizatidine norfloxacin ofloxacin omeprazole prednisone, prednisolone ranitidine rifabutin roxithromycin … |
| Nifedipine | drug interactions | … medroxyprogesterone methylprednisolone metronidazole metoprolol nadolol nifedipine nizatidine norfloxacin ofloxacin omeprazole prednisone, prednisolone ranitidine rifabutin roxithromycin sorbitol … |
| Nizatidine | drug interactions | … medroxyprogesterone methylprednisolone metronidazole metoprolol nadolol nifedipine nizatidine norfloxacin ofloxacin omeprazole prednisone, prednisolone ranitidine rifabutin roxithromycin sorbitol … |
| Ofloxacin | drug interactions | … metronidazole metoprolol nadolol nifedipine nizatidine norfloxacin ofloxacin omeprazole prednisone, prednisolone ranitidine rifabutin roxithromycin sorbitol (purgative doses do not inhibit … |
| Omeprazole | drug interactions | … metronidazole metoprolol nadolol nifedipine nizatidine norfloxacin ofloxacin omeprazole prednisone, prednisolone ranitidine rifabutin roxithromycin sorbitol (purgative doses do not inhibit … |
| 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 | … vaccine ketoconazole; lomefloxacin mebendazole medroxyprogesterone methylprednisolone metronidazole metoprolol nadolol nifedipine nizatidine norfloxacin ofloxacin omeprazole prednisone, prednisolone … |
| Prednisone | drug interactions | … metoprolol nadolol nifedipine nizatidine norfloxacin ofloxacin omeprazole prednisone, prednisolone ranitidine rifabutin roxithromycin sorbitol (purgative doses do not inhibit theophylline absorption) … |
| 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 | … nizatidine norfloxacin ofloxacin omeprazole prednisone, prednisolone ranitidine rifabutin roxithromycin sorbitol (purgative doses do not inhibit theophylline absorption) sucralfate terbutaline … |
| Rifabutin | drug interactions | … norfloxacin ofloxacin omeprazole prednisone, prednisolone ranitidine rifabutin roxithromycin sorbitol (purgative doses do not inhibit theophylline absorption) sucralfate terbutaline, systemic … |
| Rifampin | drug interactions | Drug: Rifampin; Type Of Interaction: Increases theophylline clearance by increasing cytochrome P450 1A2 and 3A3 activity.; Effect**: 20 - 40% decrease |
| Sucralfate | drug interactions | … sorbitol (purgative doses do not inhibit theophylline absorption) sucralfate terbutaline, systemic terfenadine tetracycline tocainide |
| Terbutaline | drug interactions | … (purgative doses do not inhibit theophylline absorption) sucralfate terbutaline, systemic terfenadine tetracycline tocainide |
| Tetracycline | drug interactions | … theophylline absorption) sucralfate terbutaline, systemic terfenadine tetracycline tocainide |
| Theophylline | contraindications | CONTRAINDICATIONS Aminophylline is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product including ethylenediamine. |
| Trimethoprim | drug interactions | … azithromycin caffeine, dietary ingestion cefaclor co-trimoxazole (trimethoprim and sulfamethoxazole) diltiazem dirithromycin enflurane famotidine felodipine finasteride hydrocortisone isoflurane … |
| Verapamil | drug interactions | Verapamil Similar to disulfiram. |
Other labels that name aminophylline
Source: FDA drug label (Aminophylline), Hospira, Inc., effective May 22, 2026 (SPL set 9a663ef3-881f-48bd-2689-3713b24545c2), via openFDA; the full label on DailyMed
What do FAERS reports show for aminophylline?
The FDA Adverse Event Reporting System holds 1,970 reports that list aminophylline among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 294 are coded as a death and 919 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 aminophylline?
1 other medicine is given the same way (intravenous) and in the same FDA class as aminophylline or labeled mainly for the same use (asthma), the same class first. Asthma lists all 37 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Reslizumab | Asthma | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other methylxanthines
- the pharmacologic class, with prices and generics
- Aminophylline side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other