Prescription and over-the-counter medicine
Epinephrine Brand names: Adrenalin, Auvi-Q, Neffy, Epipen, Primatene; first approved as Sus-Phrine Sulfite Free
Epinephrine (Neffy) is a prescription and over-the-counter medicine with an FDA approval on record since 1951. FDA's NDC Directory lists it from 16 generic labelers, and pharmacies paid $123.51 per unit (Epinephrine 0.15 mg auto-injct) in the October 7, 2026 NADAC survey; its other strengths are brand-only, $7.80 per mL (Adrenalin 1 mg/mL vial).
- Generic listed
- A presentation discontinued
Check it at the source: the epinephrine FDA label on DailyMed (effective July 13, 2026, A-S Medication Solutions); the NDA 7942 record on Drugs@FDA; every epinephrine label on DailyMed.
Highlights of the record
FDA label of July 13, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageEpinephrine is a non-selective alpha and beta adrenergic agonist indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
Forms and strengths
- 1 mg
- 2 mg
- 0.1 mg/ml
- 0.1 mg/.1ml
- 0.15 mg/.15ml
- 0.15 mg/.3ml
- 0.3 mg/.3ml
- 1 mg/ml
- 30 mg/30ml
Injection; injection (solution); injection (solution) (concentrate); spray; aerosol.
On the market
- Earliest approval on file
- June 8, 1951 Sus-Phrine Sulfite Free, Forest Labs; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 14 first May 23, 1984; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 32 of which 16 under generic applications, 20 under brand applications, repackagers included
- Last listed patent
- February 6, 2039 Neffy spray; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $123.51 per unit Epinephrine 0.15 mg auto-injct
- Shortage (FDA)
- None current 2 past records
- Recalls by its makers (FDA)
- 29 since 2012 8 Class I among all firms' recalls; latest August 11, 2026; 12 more by firms not listed as its makers
- FAERS reports
- 65,566 through July 30, 2026
What is epinephrine used for?
From the label: indications and usageEpinephrine is a non-selective alpha and beta adrenergic agonist indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. ( 1.1 ) 1.1 Hypotension associated with Septic Shock Epinephrine Injection USP, 1 mg/10 mL (0.1 mg/mL) is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
Conditions named in the indications of epinephrine's FDA labels, with every medicine labeled for each:
From other epinephrine labelsAsthma: Uses for temporary relief of mild symptoms of intermittent asthma ■ wheezing ■ tightness of chest ■ shortness of breath
FDA pharmacologic class: Catecholamine, alpha-Adrenergic Agonist and beta-Adrenergic Agonist.
Source: FDA drug label (Epinephrine), A-S Medication Solutions, effective July 13, 2026 (SPL set 6e811e28-0199-4df7-a916-5940c632401d), via openFDA; the full label on DailyMed
What does the patient leaflet for epinephrine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about EpiPen and EpiPen Jr?EpiPen and EpiPen Jr are single-dose automatic injection devices (auto-injectors) that contain epinephrine. Epinephrine is a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life threatening and can happen within minutes. If untreated, anaphylaxis can lead to death. This allergic emergency can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or unknown causes. Symptoms of anaphylaxis may include: • trouble breathing • wheezing • hoarseness (changes in the way your voice sounds) • hives (raised reddened rash that may itch) • severe itching • swelling of your face, lips, mouth, or tongue • skin rash, redness, or swelling • fast heartbeat • weak pulse • feeling very anxious • confusion • stomach pain • losing control of urine or bowel movements (incontinence) • diarrhea or stomach cramps • dizziness, fainting, or “passing out” (unconsciousness) • Always carry 2 EpiPen or 2 EpiPen Jr auto-injectors with you because sometimes a single dose of epinephrine may not be enough to treat a serious allergic reaction before seeking medical care. You also need to always carry 2 auto-injectors with you if the first auto-injector is activated before the dose can be given. A device that has been activated by accident cannot be used in an allergic emergency (anaphylaxis). Note: The EpiPen or EpiPen Jr auto-injector has been activated when the blue safety top is removed and a “pop” is heard, the orange needle end of the auto-injector is extended, or the medicine viewing window is blocked. You may not know when anaphylaxis will happen. Talk to your healthcare provider if you need more auto-injectors to keep at work, school, or other locations. […]
From the patient leaflet: How should I store EpiPen or EpiPen Jr auto-injectors?Store EpiPen and EpiPen Jr auto-injectors at room temperature between 68° F to 77° F (20° C to 25° C). • Keep this medicine out of the sight and reach of young children. • Keep protective case in the outer carton to protect from light. When exposed to air or light epinephrine changes quickly to a pinkish or brown color and should not be used. • Do not expose to extreme cold or heat. For example, do not store in your vehicle’s glove box or trunk. Do not store in the refrigerator or freezer. • Examine the contents in the medicine viewing window of your EpiPen or EpiPen Jr auto-injector regularly. The medicine should be clear. If the medicine is discolored (pinkish or brown color) or contains solid particles, replace the auto-injector. • Always keep your 2 EpiPen or 2 EpiPen Jr auto-injectors in the protective cases to prevent damage to the device. The protective case is not waterproof. […]
Source: FDA drug label (EPIPEN), Viatris Specialty LLC, effective February 15, 2023 (SPL set 7560c201-9246-487c-a13b-6295db04274a), via openFDA; the full label on DailyMed
Is there a generic for epinephrine (Neffy)?
The FDA approved the first generic epinephrine on May 23, 1984. 14 generic applications are approved; 12 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists epinephrine from 16 labelers under a generic (ANDA) application and from 20 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 8 patents for Neffy spray, the last expiring on February 6, 2039; a patent listed only for Epinephrine injection runs to January 17, 2045. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1951 earliest approval on file
- 1984 first generic approved
- 2039 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for epinephrine (Neffy)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $123.51 per unit (Epinephrine 0.15 mg auto-injct), down 3% from $127.91 on October 8, 2025. 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.
- Epinephrine 0.3 mg auto-inject (generic)
- Adrenalin 1 mg/mL vial (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Epinephrine 0.15 mg auto-injct | Generic | $123.51 per unit | n/a | -3% |
| Epinephrine 0.3 mg auto-inject | Generic | $122.80 per unit | n/a | -0.5% |
| Epinephrine 1 mg/10 mL luerjet | Generic | $1.24 per mL | n/a | +6% |
| Adrenalin 1 mg/mL vial | Brand | $7.80 per mL | n/a | -45% |
| Auvi-q 0.1 mg auto-injector | Brand | $309.55 per unit | n/a | +4% |
| Auvi-q 0.15 mg auto-injector | Brand | $309.85 per unit | n/a | +4% |
| Auvi-q 0.3 mg auto-injector | Brand | $309.38 per unit | n/a | +4% |
| Neffy 1 mg/0.1 mL nasal spray | Brand | $360.14 per unit | n/a | +6% |
| Neffy 2 mg/0.1 mL nasal spray | Brand | $359.49 per unit | n/a | +6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is epinephrine in shortage?
No epinephrine presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated November 7, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Epinephrine, Injection, .1 mg/1 mL (NDC 0409-4933-01) | Hospira, Inc., a Pfizer Company | To Be Discontinued | November 7, 2025 |
| Epinephrine, Injection, .1 mg/1 mL (NDC 0409-4933-10) | Hospira, Inc., a Pfizer Company | To Be Discontinued | November 7, 2025 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has epinephrine been recalled?
The FDA's Enforcement Report lists 41 recalls naming epinephrine since 2012: 8 Class I (the most serious), 32 Class II, 1 Class III; 5 still ongoing. 12 of them are by firms that FDA's NDC Directory does not list as a maker of epinephrine 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 |
|---|---|---|---|
| August 11, 2026 | Class I | American Regent, Inc. | Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and … |
| May 14, 2026 | Class III | Fresenius Kabi USA, LLC | Failed Impurities/Degradations Specifications |
| April 1, 2026 | Class II | International Medication Systems Ltd. | Lack of Assurance of Sterility |
| January 17, 2024 | Class II | Henry Schein Inc. and Glove Club HSI Gloves Inc. | Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect. |
| August 17, 2023 | Class II | Central Admixture Pharmacy Services, Inc. not a listed maker | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles |
| July 14, 2023 | Class II | Central Admixture Pharmacy Services, Inc. | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. |
| December 19, 2022 | Class I | Spectrum Laboratory Products, Inc. not a listed maker | Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product |
| June 30, 2022 | Class II | Nephron Sterile Compounding Center 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 epinephrine label say about other medicines?
The epinephrine label names 11 other medicines in its interaction, contraindication or warning sections. The labels of 46 other medicines name epinephrine. 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 |
|---|---|---|
| Chlorpheniramine | drug interactions | Antidepressants, Monoamine Oxidase Inhibitors, Levothyroxine, and Antihistamines The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine. |
| Clonidine | drug interactions | … epinephrine include sympathomimetics, beta blockers, tricyclic antidepressants, MAO inhibitors, COMT inhibitors, clonidine, doxapram, oxytocin, levothyroxine sodium, and certain antihistamines. ( 7 .2) Drugs that increase the arrhythmogenic potential of epinephrine include beta blockers, cyclopropane and halogenated … |
| Diphenhydramine | drug interactions | Antidepressants, Monoamine Oxidase Inhibitors, Levothyroxine, and Antihistamines The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine. |
| Doxapram | drug interactions | … include sympathomimetics, beta blockers, tricyclic antidepressants, MAO inhibitors, COMT inhibitors, clonidine, doxapram, oxytocin, levothyroxine sodium, and certain antihistamines. ( 7 .2) Drugs that increase the arrhythmogenic potential of epinephrine include beta blockers, cyclopropane and halogenated hydrocarbon … |
| Entacapone | drug interactions | Drugs Potentiating Pressor Effects of Epinephrine Sympathomimetics β-blockers, such as propranolol Tricyclic anti-depressants Monoamine oxidase (MAO) inhibitors Catechol-O-methyl transferase (COMT) inhibitors, such as entacapone Clonidine Doxapram Oxytocin 7.3. |
| Imipramine | warnings and precautions | Patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of triptyline or imipramine types may experience severe, prolonged hypertension when given epinephrine. |
| Levothyroxine | drug interactions | … beta blockers, tricyclic antidepressants, MAO inhibitors, COMT inhibitors, clonidine, doxapram, oxytocin, levothyroxine sodium, and certain antihistamines. ( 7 .2) Drugs that increase the arrhythmogenic potential of epinephrine include beta blockers, cyclopropane and halogenated hydrocarbon anesthetics, quinidine … |
| Phentolamine | drug interactions | α-blockers, such as phentolamine Vasodilators, such as nitrates |
| Propranolol | drug interactions | β-blockers, such as propranolol |
| Quinidine | drug interactions | … arrhythmogenic potential of epinephrine include beta blockers, cyclopropane and halogenated hydrocarbon anesthetics, quinidine, antihistamines, exogenous thyroid hormones, diuretics, and cardiac glycosides. |
| Theophylline | drug interactions | Observe for development of cardiac arrhythmias. ( 7 .3) Potassium-depleting drugs, including corticosteroids, diuretics, and theophylline, potentiate the hypokalemic effects of epinephrine. ( 7 .4) |
Other labels that name epinephrine
- Agalsidase beta
- Albuterol
- Alglucosidase alfa
- Alteplase
- Amitriptyline
- Asfotase alfa
- Asparaginase
- Benazepril and hydrochlorothiazide
- Bevacizumab
- Bupivacaine
- Calaspargase
- Cerliponase alfa
- Cocaine
- Codeine and phenylephrine and promethazine
- Coral snake immune globulin antivenin
- Digoxin
- Dihydroergotamine
- Dopamine
- Elamipretide
- Elosulfase alfa
- Ergotamine
- Esmolol
- Fentanyl
- Fosinopril
- Galsulfase
- Glimepiride
- Glipizide
- Human botulinum neurotoxin a b immune globulin
- Hyaluronidase
- Hydrochlorothiazide and quinapril
- Imiglucerase
- Insulin aspart
- Insulin degludec
- Insulin detemir
- Insulin glargine
- Insulin glulisine
- Insulin human
- Insulin lispro
- Iodixanol
- Isocarboxazid
- Isoproterenol
- Laronidase
- Levalbuterol
- Lidocaine
- Linezolid
- Loxapine
- Margetuximab
- Milnacipran
- Opicapone
- Pegaspargase
- Pegzilarginase
- Perphenazine
- Phenelzine
- Phenoxybenzamine
- Protriptyline
- Raxibacumab
- Remifentanil
- Repaglinide
- Sevoflurane
- Sufentanil
- Taliglucerase alfa
- Timolol
- Tividenofusp alfa
- Trandolapril and verapamil
- Tranylcypromine
- Trastuzumab
- Velaglucerase alfa
Source: FDA drug label (Epinephrine), A-S Medication Solutions, effective July 13, 2026 (SPL set 6e811e28-0199-4df7-a916-5940c632401d), via openFDA; the full label on DailyMed
What do FAERS reports show for epinephrine?
The FDA Adverse Event Reporting System holds 65,566 reports that list epinephrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,097 are coded as a death and 17,922 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 next?
- Other catecholamines
- the pharmacologic class, with prices and generics
- Epinephrine side effects
- the label's list beside FAERS reports
- Epinephrine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other