oraverse
Pharmaranks rates Oraverse 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Oraverse (Phentolamine Mesylate) is an alpha-adrenergic blocker used to treat Extravasation of Diagnostic and Therapeutic Materials, Malignant Hypertension, Necrosis.
Phentolamine Mesylate · by Septodont
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Phentolamine Mesylate
- Drug class
- Alpha-Adrenergic Blocker
- Form
- Injectable
- Strength
- Phentolamine Mesylate 0.4MG/1.7ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Septodont
- FDA application
- NDA022159
What is Oraverse?
From the FDA label:Phentolamine mesylate is phenol,3-[[(4,5-dihydro-1 H -imidazol-2-yl)methyl](4-methyl-phenyl)amino]-,methanesulfonate (salt), a non-specific alpha adrenergic blocker. Phentolamine mesylate USP is a white to off-white, odorless crystalline powder with a molecular weight of 377.46. It is sparingly soluble in water, soluble in alcohol, and slightly soluble in chloroform. The empirical formulation is C 17 H 19 N 3 O•CH 4 O 3 S, and the chemical structure is: OraVerse (phentolamine mesylate) Injection is a clear, colorless, sterile, non pyrogenic, isotonic, preservative free solution. Each 1.7 mL cartridge contains 0.4 mg phentolamine mesylate, D-mannitol, edetate disodium, and sodium acetate. Either acetic acid or sodium hydroxide is used as necessary to adjust the pH. Chemical Structure
How to use
Amount of Local Anesthetic Administered Dose of OraVerse 1 / 4 Cartridge 1 / 4 Cartridge (0.1 mg) ½ Cartridge ½ Cartridge (0.2 mg) 1 Cartridge 1 Cartridge (0.4 mg) 2 Cartridges 2 Cartridges (0.8 mg) OraVerse is administered using the same location(s) and same technique(s) (infiltration or block injection) used for the administration of local anesthetic. ( 2.1 ) 2.1 General Dosing information The recommended dose of OraVerse is based on the number of cartridges of local anesthetic with vasoconstrictor administered: Amount of Local Anesthetic Administered Dose of OraVerse [mg] Dose of OraVerse [Cartridge(s)] 1 / 4 Cartridge 0.1 1 / 4 ½ Cartridge 0.2 ½ 1 Cartridge 0.4 1 2 Cartridges 0.8 2 OraVerse should be administered following the dental procedure using the same location(s) and technique(s) (infiltration or block injection) employed for the administration of the local anesthetic. Chemically disinfect the carpule cap by wiping with either isopropyl alcohol (91%) or ethyl alcohol (70%). Many commercially available brands of isopropyl (rubbing) alcohol, as well as solutions of ethyl alcohol not of U.S.P. grade, contain denaturants that are injurious to rubber and therefore are not to be used. Inspect carpules visually prior to administration and do not use if particulate matter, discoloration, cracks in the glass, protruding plungers or other defects are observed. Note: Do not…
Side effects
In clinical trials, the most common adverse reaction with OraVerse that was greater than the control group was injection site pain. The most common adverse reaction with OraVerse (incidence ≥5% and > control) is injection-site pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Septodont at 1-888-888-1441 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Dental patients were administered a dose of either 0.2, 0.4 or 0.8mg of OraVerse. The majority of adverse reactions were mild and resolved within 48 hours. There were no serious adverse reactions and no discontinuations due to adverse reactions. Table 1 lists adverse reactions where the frequency was greater than or equal to 3% in any OraVerse dose group and was equal to or exceeded that of the control group. Table 1: Adverse Reactions with Frequency Greater Than or Equal to 3% and Equal to or Exceeding Control Adverse Event OraVerse Control 0.2 mg (N = 83) 0.4 mg (N = 284) 0.8 mg (N = 51) Total (N = 418) Total (N = 359) N (%) N (%) N (%) N (%) N (%) Patients with AEs 15 (18) 82 (29) 20 (39) 117 (28) 96 (27) Tachycardia 0 (0) 17…
Warnings
Important safety information
Myocardial infarction, cerebrovascular spasm, and cerebrovascular occlusion have been reported to occur following the intravenous or intramuscular administration of phentolamine, usually in association with marked hypotensive episodes or shock-like states which occasionally follow parenteral administration. Tachycardia and cardiac arrhythmiasmay occur with the use of phentolamine or other alpha-adrenergic blocking agents. ( 5.1 ) 5.1 Cardiovascular Events Myocardial infarction, cerebrovascular spasm, and cerebrovascular occlusion have been reported to occur following the parenteral administration of phentolamine. These events usually occurred in association with marked hypotensive episodes producing shock-like states. Tachycardia and cardiac arrhythmias may occur with the use of phentolamine or other alpha-adrenergic blocking agents. Although such effects are uncommon after administration of OraVerse, clinicians should be alert to the signs and symptoms of these events, particularly in patients with a prior history of cardiovascular disease.
Who should not take Oraverse
OraVerse is contraindicated in patients with: Hypersensitivity to the active substance or to any ingredients in the formulation OraVerse is contraindicated in patients with: Hypersensitivity to the active substance or to any ingredients in the formulation. ( 4 )
Overdose — what happens if you take too much
No deaths due to acute poisoning with phentolamine have been reported. Overdosage with parenterally administered phentolamine is characterized chiefly by cardiovascular disturbances, such as arrhythmias, tachycardia, hypotension, and possibly shock. In addition, the following might occur: excitation, headache, sweating, pupillary contraction, visual disturbances, nausea, vomiting, diarrhea, or hypoglycemia. There is no specific antidote; treatment consists of appropriate monitoring and supportive care. Substantial decreases in blood pressure or other evidence of shock-like conditions should be treated vigorously and promptly.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
There are no known drug interactions with OraVerse. 7.1 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 AUC and Cmax values were not affected by administration of OraVerse. OraVerse administration did not affect the PK of epinephrine.
Drug class
How this class works, per Alpha-Blockers - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Oraverse ranks — best-rated alpha-adrenergic blocker for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- What does Oraverse treat?
- Oraverse (Phentolamine Mesylate) may be used to treat extravasation of diagnostic and therapeutic materials, malignant hypertension, necrosis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Oraverse work?
- Oraverse is a alpha-adrenergic blocker. Alpha-adrenergic blockers block the alpha-1 receptors that adrenaline-like signals use to tighten muscle in blood vessels and the prostate. This relaxes those muscles, lowering blood pressure and easing urine flow in men with an enlarged prostate.
- How is Oraverse rated?
- pharmaranks gives Oraverse a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Oraverse?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Oraverse. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Oraverse?
- Oraverse is marketed by Septodont. You can see Septodont's full profile, rating, and other products on pharmaranks.
- Is Oraverse a brand-name or generic drug?
- Oraverse is a brand-name product with the active ingredient Phentolamine Mesylate.
- Is Oraverse available over the counter?
- No. Oraverse is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Oraverse come in?
- Oraverse is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Oraverse?
- Oraverse is classified as alpha-adrenergic blocker, per the FDA's Established Pharmacologic Class.
- Is Oraverse FDA-registered?
- Oraverse is on record with the U.S. FDA under application number NDA022159. You can verify this on its official FDA label.
- Has Oraverse been recalled by the FDA?
- Yes. Oraverse has 2 recorded FDA recall events in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.
- Is Oraverse safe?
- There's no single safe-or-not verdict. pharmaranks gives Oraverse a recall-safety score of 70/100, based on its FDA recall history (2 recorded recall events) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Oraverse?
- Oraverse's side effects are taken directly from its FDA label. From the label: In clinical trials, the most common adverse reaction with OraVerse that was greater than the control group was injection site pain. The most common adverse reaction with OraVerse (incidence ≥5% and > control) is injection-site pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
What people report to the FDA about PHENTOLAMINE MESYLATE
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 92 reports naming PHENTOLAMINE MESYLATE — the active ingredient in Oraverse, and the FDA flagged 90% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- blood urea increased14 reports
- anaemia13 reports
- blood glucose increased13 reports
- neutrophil count increased13 reports
- diarrhoea12 reports
- lymphocyte count decreased12 reports
- hypertension11 reports
- abdominal distension9 reports
Read these as a signal, not a rate. A report does not mean PHENTOLAMINE MESYLATE caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 27, 2026.
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oraverse
70/100