Prescription medicine
Doxapram First approved as Dopram
Doxapram (Dopram) is a prescription medicine with an FDA approval on record since 1965. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the doxapram FDA label on DailyMed (effective April 9, 2024, Hikma Pharmaceuticals USA Inc.); the NDA 14879 record on Drugs@FDA; every doxapram label on DailyMed.
Highlights of the record
FDA label of April 9, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagePostanesthesia When the possibility of airway obstruction and/or hypoxia have been eliminated, doxapram may be used to stimulate respiration in patients with drug-induced postanesthesia respiratory depression or apnea other than that due to muscle relaxant drugs.
Forms and strengths
- 20 mg/ml
Injection.
On the market
- Earliest approval on file
- June 23, 1965 Dopram, Hikma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first January 30, 1992; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 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)
- 0 since 2013 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 22 through July 30, 2026
What is doxapram used for?
From the label: indications and usagePostanesthesia When the possibility of airway obstruction and/or hypoxia have been eliminated, doxapram may be used to stimulate respiration in patients with drug-induced postanesthesia respiratory depression or apnea other than that due to muscle relaxant drugs. To pharmacologically stimulate deep breathing in the postoperative patient. […]
FDA pharmacologic class: Respiratory Stimulant.
Source: FDA drug label (Dopram), Hikma Pharmaceuticals USA Inc., effective April 9, 2024 (SPL set b8eb330a-a75b-46cb-b694-5be9327ed2eb), via openFDA; the full label on DailyMed
Is there a generic for doxapram (Dopram)?
The FDA approved the first generic doxapram on January 30, 1992. 2 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.
- 1965 earliest approval on file
- 1992 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has doxapram been recalled?
The FDA's Enforcement Report lists 1 recall naming doxapram since 2013: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of doxapram and that holds 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 |
|---|---|---|---|
| May 29, 2013 | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy not a listed maker | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the doxapram label say about other medicines?
The doxapram label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name doxapram. 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 |
|---|---|---|
| Aminophylline | drug interactions | There may be an interaction between doxapram and aminophylline and between doxapram and theophylline manifested by increased skeletal muscle activity, agitation, and hyperactivity. |
| Theophylline | drug interactions | There may be an interaction between doxapram and aminophylline and between doxapram and theophylline manifested by increased skeletal muscle activity, agitation, and hyperactivity. |
Other labels that name doxapram
Source: FDA drug label (Dopram), Hikma Pharmaceuticals USA Inc., effective April 9, 2024 (SPL set b8eb330a-a75b-46cb-b694-5be9327ed2eb), via openFDA; the full label on DailyMed
What do FAERS reports show for doxapram?
The FDA Adverse Event Reporting System holds 22 reports that list doxapram among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7 are coded as a death and 8 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Doxapram side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other