Prescription medicine
Phentolamine Brand names: Ryzumvi, Oraverse; first approved as Regitine
Phentolamine (Ryzumvi) is a prescription medicine with an FDA approval on record since 1952. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
Check it at the source: the phentolamine FDA label on DailyMed (effective March 15, 2026, Oyster Point Pharma, Inc.); the NDA 8278 record on Drugs@FDA; every phentolamine label on DailyMed.
Highlights of the record
FDA label of March 15, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageRYZUMVI is indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic agents (e.g., tropicamide).
Forms and strengths
- 5 mg
- 0.235 mg/ml
- 5 mg/ml
- 10 mg/ml
Injection (powder) for solution; solution/ drops; injection (solution); injection.
On the market
- Earliest approval on file
- January 30, 1952 Regitine, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first March 11, 1998; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 2 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- October 25, 2039 Ryzumvi solution; 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)
- 3 since 2012 0 Class I among all firms' recalls; latest October 31, 2025; 4 more by firms not listed as its makers
- FAERS reports
- 158 through July 30, 2026
What is phentolamine used for?
From the label: indications and usageRYZUMVI is indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic agents (e.g., tropicamide). RYZUMVI is an alpha-adrenergic blocker indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic agents (e.g., tropicamide).
FDA pharmacologic class: alpha-Adrenergic Blocker.
Source: FDA drug label (Ryzumvi), NDA217064 (Famygen Life Sci), as published by Oyster Point Pharma, Inc., effective March 15, 2026 (SPL set 96bb1e53-c2cc-4e60-a21a-db0269c371bf), via openFDA; the full label on DailyMed
Is there a generic for phentolamine (Ryzumvi)?
The FDA approved the first generic phentolamine on March 11, 1998. 2 generic applications are approved; 2 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 phentolamine from 2 labelers under a generic (ANDA) application and from 2 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 11 patents for Ryzumvi solution, the last expiring on October 25, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1952 earliest approval on file
- 1998 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)
Has phentolamine been recalled?
The FDA's Enforcement Report lists 7 recalls naming phentolamine since 2012: 0 Class I (the most serious), 6 Class II, 1 Class III; 3 still ongoing. 4 of them are by firms that FDA's NDC Directory does not list as a maker of phentolamine 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 |
|---|---|---|---|
| October 31, 2025 | Class II | Novocol Pharmaceutical of Canada, Inc. | Defective container: cracked/broken cartridges |
| October 7, 2022 | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder not a listed maker | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products … |
| September 10, 2018 | Class II | Pharm D Solutions, LLC | Lack of Assurance of Sterility |
| April 13, 2018 | Class III | Septodont Inc. | Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance … |
| August 27, 2014 | Class II | Martin Avenue Pharmacy, Inc. not a listed maker | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. … |
| 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 |
| May 21, 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. … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the phentolamine label say about other medicines?
The phentolamine label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 10 other medicines name phentolamine. 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 |
|---|---|---|
| Epinephrine | drug interactions | Lidocaine and Epinephrine When OraVerse was administered as an intraoral submucosal injection 30 minutes after injection of a local anesthetic, 2% lidocaine HCl with 1:100,000 epinephrine, the lidocaine concentration increased immediately after OraVerse intraoral injection. |
| Lidocaine | drug interactions | Lidocaine and Epinephrine When OraVerse was administered as an intraoral submucosal injection 30 minutes after injection of a local anesthetic, 2% lidocaine HCl with 1:100,000 epinephrine, the lidocaine concentration increased immediately after OraVerse intraoral injection. |
Other labels that name phentolamine
Source: FDA drug label (Ryzumvi), NDA217064 (Famygen Life Sci), as published by Oyster Point Pharma, Inc., effective March 15, 2026 (SPL set 96bb1e53-c2cc-4e60-a21a-db0269c371bf), via openFDA; the full label on DailyMed
What do FAERS reports show for phentolamine?
The FDA Adverse Event Reporting System holds 158 reports that list phentolamine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11 are coded as a death and 44 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 blockers
- the pharmacologic class, with prices and generics
- Phentolamine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other