Prescription and over-the-counter medicine
Ephedrine Brand names: Emerphed, Akovaz
Ephedrine (Akovaz) is a prescription and over-the-counter medicine with an FDA approval on record since 2016. FDA's NDC Directory lists it from 19 generic labelers.
- Generic listed
Check it at the source: the ephedrine FDA label on DailyMed (effective September 16, 2024, Nexus Pharmaceuticals, LLC); the NDA 208289 record on Drugs@FDA; every ephedrine label on DailyMed.
Highlights of the record
FDA label of September 16, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageINDICATIONS AND USAGE EMERPHED and EMERPHED-PFS is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
Forms and strengths
- 5 mg/ml
- 50 mg/ml
Injection; injection (solution).
On the market
- Earliest approval on file
- April 29, 2016 Akovaz, Exela Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 18 first August 23, 2017; 16 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 24 of which 19 under generic applications, 5 under brand applications, repackagers included; 4 more under the over-the-counter monograph, without an application
- Last listed patent
- May 16, 2040 Emerphed injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 20 since 2014 0 Class I among all firms' recalls; latest April 26, 2023; 7 more by firms not listed as its makers
- FAERS reports
- 212 through July 30, 2026
What is ephedrine used for?
From the label: indications and usageINDICATIONS AND USAGE EMERPHED and EMERPHED-PFS is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. EMERPHED and EMERPHED-PFS is an alpha- and beta- adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
Conditions named in the indications of ephedrine's FDA labels, with every medicine labeled for each:
From other ephedrine labelsAsthma: Use for temporary relief of mild symptoms of intermittent asthma: wheezing tightness of chest shortness of breath
FDA pharmacologic class: Norepinephrine Releasing Agent, alpha-Adrenergic Agonist and beta-Adrenergic Agonist.
Source: FDA drug label (Emerphed PFS), Nexus Pharmaceuticals, LLC, effective September 16, 2024 (SPL set 14601778-93ac-43ec-b66b-5a942317133f), via openFDA; the full label on DailyMed
Is there a generic for ephedrine (Akovaz)?
The FDA approved the first generic ephedrine on August 23, 2017. 18 generic applications are approved; 16 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 ephedrine from 19 labelers under a generic (ANDA) application and from 5 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Akovaz injection; a patent listed only for Emerphed injection runs to May 16, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2016 earliest approval on file
- 2017 first generic approved
- 2040 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has ephedrine been recalled?
The FDA's Enforcement Report lists 27 recalls naming ephedrine since 2014: 0 Class I (the most serious), 27 Class II, 0 Class III; 1 still ongoing. 7 of them are by firms that FDA's NDC Directory does not list as a maker of ephedrine 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 |
|---|---|---|---|
| April 26, 2023 | Class II | Akorn, Inc. | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| December 17, 2020 | Class II | SCA Pharmaceuticals | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit |
| March 16, 2020 | Class II | PharMEDium Services, LLC | Firm is recalling 46 lots of various products because of a lack of sterility assurance. |
| June 19, 2019 | Class II | RXQ Compounding LLC not a listed maker | Lack of Assurance of Sterility |
| January 29, 2019 | Class II | US Compounding Inc not a listed maker | Lack of assurance of sterility. |
| June 12, 2018 | Class II | Avella of Deer Valley, Inc. Store 38 | Lack of Assurance of Sterility: Potential leakage of bags. |
| December 7, 2017 | Class II | SCA Pharmaceuticals | Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date. |
| October 10, 2017 | Class II | Banner Pharmacy Services, LLC not a listed maker | Lack of Assurance of Sterility. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ephedrine label say about other medicines?
The ephedrine label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 14 other medicines name ephedrine. 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 |
|---|---|---|
| Atropine | drug interactions | Clonidine, propofol, monoamine oxidase inhibitors (MAOIs), atropine Clinical Impact: These drugs augment the pressor effect of ephedrine. Intervention: Carefully monitor the blood pressure of individuals who have received both EMERPHED and EMERPHED-PFS and any of these drugs. |
| Clonidine | drug interactions | Clonidine, propofol, monoamine oxidase inhibitors (MAOIs), atropine Clinical Impact: These drugs augment the pressor effect of ephedrine. Intervention: Carefully monitor the blood pressure of individuals who have received both EMERPHED and EMERPHED-PFS and any of these drugs. |
| Methylergonovine | drug interactions | Oxytocin and oxytocic drugs Clinical Impact: Serious postpartum hypertension has been described in patients who received both a vasopressor (…) and an oxytocic (…). Some of these patients experienced a stroke. Intervention: Carefully monitor the blood pressure of individuals who have received both EMERPHED and EMERPHED-PFS and an oxytocic. |
| Propofol | drug interactions | Clonidine, propofol, monoamine oxidase inhibitors (MAOIs), atropine Clinical Impact: These drugs augment the pressor effect of ephedrine. Intervention: Carefully monitor the blood pressure of individuals who have received both EMERPHED and EMERPHED-PFS and any of these drugs. |
| Quinidine | drug interactions | Clinical Impact: These drugs augment the pressor effect of ephedrine. … Effect α-adrenergic antagonists, β-adrenergic receptor antagonists, reserpine, quinidine, mephentermine |
| Rocuronium | drug interactions | Rocuronium Clinical Impact: EMERPHED and EMERPHED-PFS may reduce the onset time of neuromuscular blockade when used for intubation with rocuronium if administered simultaneously with anesthetic induction. Intervention: Be aware of this potential interaction. No treatment or other interventions are needed. |
| Theophylline | drug interactions | Theophylline: Concomitant use of EMERPHED and EMERPHED-PFS may increase the frequency of nausea, nervousness, and insomnia. |
Other labels that name ephedrine
Source: FDA drug label (Emerphed PFS), Nexus Pharmaceuticals, LLC, effective September 16, 2024 (SPL set 14601778-93ac-43ec-b66b-5a942317133f), via openFDA; the full label on DailyMed
What do FAERS reports show for ephedrine?
The FDA Adverse Event Reporting System holds 212 reports that list ephedrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 23 are coded as a death and 51 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?
- Other alpha-adrenergic agonists
- the pharmacologic class, with prices and generics
- Ephedrine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other