Mediclarum
Medicine guide

Upneeq

1 mg/mL · Solution/ Drops

  • Prescription only
  • Vasoconstrictor
Made by
RVL Pharmaceuticals, Inc.

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-07-23

What it is

Vasoconstrictor

Used for
  • UPNEEQ is indicated for the treatment of acquired blepharoptosis in
  • Adults. UPNEEQ is indicated for the treatment of acquired blepharoptosis in
  • Adults. ( 1 )
Do not take it if

None. None. ( 4 )

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • UPNEEQ is indicated for the treatment of acquired blepharoptosis in
  • adults. UPNEEQ is indicated for the treatment of acquired blepharoptosis in
  • adults. ( 1 )

From the official label · 2026-07-23 · DailyMed

How it works

From this product’s own US prescribing label.

Oxymetazoline is an alpha adrenoceptor agonist targeting a subset of adrenoreceptors in Mueller’s muscle of the eyelid.

Peak level after0.5–12 h
Half-life8.3 h
Mostly cleared after≈ 41.5 hfive half-lives — our arithmetic
PeakHalf gone41.5 h0
The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.
How the body breaks it down

In vitro studies using human liver microsomes showed that oxymetazoline was minimally metabolized, generating mono-oxygenated and dehydrogenated products of oxymetazoline.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-07-23

Do not take it if

None. None. ( 4 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • Instill one drop of UPNEEQ into one or both ptotic eye(s) once daily.
  • Discard the single patient-use container immediately after dosing.
  • Contact lenses should be removed prior to instillation of UPNEEQ and may be reinserted 15 minutes following its administration.
  • If more than one topical ophthalmic drug is being used, the drugs should be administered at least 15 minutes between applications.
  • Instill one drop into one or both ptotic eye(s) once daily.
  • ( 2 )

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • ( 5.1 ) Alpha-adrenergic agonists as a class may impact blood pressure.
  • ( 5.2 ) Use with caution in patients with cerebral or coronary insufficiency or Sjögren’s syndrome and advise patients to seek medical care if signs and symptoms of potentiation of vascular insufficiency develop.
  • ( 5.3 ) Advise patients to seek immediate medical care
  • if pain, redness, blurred vision and photophobia occur (signs and symptoms of acute angle closure).
  • ( 5.4 )
  • 5.1 Ptosis as Presenting Sign of Serious Neurologic Disease Ptosis may be associated with neurologic or orbital diseases such as stroke and/or cerebral aneurysm, Horner syndrome, myasthenia gravis, external ophthalmoplegia, orbital infection and orbital masses.
  • 5.2 Potential Impacts on Cardiovascular Disease Alpha-adrenergic agonists may impact blood pressure.
  • UPNEEQ should be used with caution in patients with severe or unstable cardiovascular disease, orthostatic hypotension, and uncontrolled hypertension or hypotension.
  • Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension to seek immediate medical care if their condition worsens.
  • 5.3 Potentiation of Vascular Insufficiency UPNEEQ should be used with caution in patients with cerebral or coronary insufficiency, or Sjögren’s syndrome.
  • Advise patients to seek immediate medical care if signs and symptoms of potentiation of vascular insufficiency develop.
  • 5.4 Risk of Angle Closure Glaucoma UPNEEQ may increase the risk of angle closure glaucoma in patients with untreated narrow-angle glaucoma.
  • Advise patients to seek immediate medical care if signs and symptoms of acute angle closure glaucoma develop.
  • 5.5 Risk of Contamination Patients should not touch the tip of the single patient-use container to their eye or to any surface, in order to
  • 5.2 Potential Impacts on Cardiovascular Disease Alpha-adrenergic agonists may impact blood pressure.
  • UPNEEQ should be used with caution in patients with severe or unstable cardiovascular disease, orthostatic hypotension, and uncontrolled hypertension or hypotension.
  • Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension to seek immediate medical care if their condition worsens.
  • 5.3 Potentiation of Vascular Insufficiency UPNEEQ should be used with caution in patients with cerebral or coronary insufficiency, or Sjögren’s syndrome.
  • Advise patients to seek immediate medical care if signs and symptoms of potentiation of vascular insufficiency develop.
  • 5.4 Risk of Angle Closure Glaucoma UPNEEQ may increase the risk of angle closure glaucoma in patients with untreated narrow-angle glaucoma. Advise patients to seek immediate medical care if signs and symptoms of acute angle closure glaucoma develop.
  • 5.5 Risk of Contamination Patients should not touch the tip of the single patient-use container to their eye or to any surface, in order to

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Risk Summary There are no available data on UPNEEQ use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage.
  • In animal reproduction studies, there were no adverse developmental effects observed after oral administration of oxymetazoline hydrochloride in pregnant rats and rabbits at systemic exposures up to 7 and 278 times the maximum recommended human ophthalmic dose (MRHOD), respectively, based on dose comparison. [see Data] .
  • The estimated background risks of major birth defects and miscarriage for the indicated population are unknown.
  • All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
  • In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
  • Animal Data Effects on embryo-fetal development were evaluated in rats and rabbits following oral administration of oxymetazoline hydrochloride during the period of organogenesis.
  • Oxymetazoline hydrochloride did not cause adverse effects to the fetus at oral doses up to 0.2 mg/kg/day in pregnant rats during the period of organogenesis (28 times the MRHOD, on a dose comparison basis).
  • Oxymetazoline hydrochloride did not cause adverse effects to the fetus at oral doses up to 1 mg/kg/day in pregnant rabbits during the period of organogenesis (278 times the MRHOD, on a dose comparison basis).
  • Maternal toxicity, including decreased maternal body weight, was produced at the high dose of 1 mg/kg/day in pregnant rabbits and was associated with findings of delayed skeletal ossification.
  • In a rat prenatal and postnatal development study, oxymetazoline hydrochloride was orally administered to pregnant rats once daily from gestation day 6 through lactation day 20.
  • Maternal toxicity was produced at the high dose of 0.2 mg/kg/day (28 times the MRHOD, on a dose comparison basis) in pregnant rats and was associated with an increase in pup mortality and reduced pup body weights.
  • Delayed sexual maturation was noted at 0.1 mg/kg/day (14 times the MRHOD, on a dose comparison basis).
  • Oxymetazoline hydrochloride did not have any adverse effects on fetal development at a dose of 0.05 mg/kg/day (7 times the MRHOD, on a dose comparison basis).
  • IN SPECIFIC POPULATIONS
  • 8.1 Pregnancy Risk Summary There are no available data on UPNEEQ use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage.
  • In animal reproduction studies, there were no adverse developmental effects observed after oral administration of oxymetazoline hydrochloride in pregnant rats and rabbits at systemic exposures up to 7 and 278 times the maximum recommended human ophthalmic dose (MRHOD), respectively, based on dose comparison. [see Data] .
  • The estimated background risks of major birth defects and miscarriage for the indicated population are unknown.
  • All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
  • In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
  • Animal Data Effects on embryo-fetal development were evaluated in rats and rabbits following oral administration of oxymetazoline hydrochloride during the period of organogenesis.
  • Oxymetazoline hydrochloride did not cause adverse effects to the fetus at oral doses up to 0.2 mg/kg/day in pregnant rats during the period of organogenesis (28 times the MRHOD, on a dose comparison basis).
  • Oxymetazoline hydrochloride did not cause adverse effects to the fetus at oral doses up to 1 mg/kg/day in pregnant rabbits during the period of organogenesis (278 times the MRHOD, on a dose comparison basis).
  • Maternal toxicity, including decreased maternal body weight, was produced at the high dose of 1 mg/kg/day in pregnant rabbits and was associated with findings of delayed skeletal ossification.
  • In a rat prenatal and postnatal development study, oxymetazoline hydrochloride was orally administered to pregnant rats once daily from gestation day 6 through lactation day 20.
  • Maternal toxicity was produced at the high dose of 0.2 mg/kg/day (28 times the MRHOD, on a dose comparison basis) in pregnant rats and was associated with an increase in pup mortality and reduced pup body weights.
  • Delayed sexual maturation was noted at 0.1 mg/kg/day (14 times the MRHOD, on a dose comparison basis).
  • Oxymetazoline hydrochloride did not have any adverse effects on fetal development at a dose of 0.05 mg/kg/day (7 times the MRHOD, on a dose comparison basis).
  • 8.2 Lactation Risk Summary No clinical data are available to assess the effects of oxymetazoline on the quantity or rate of breastmilk production, or to establish the level of oxymetazoline present in human breastmilk post-dose.
  • Oxymetazoline was detected in the milk of lactating rats.
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for UPNEEQ and any potential adverse effects on the breastfed child from UPNEEQ.
  • 8.4 Pediatric Use Safety and effectiveness of UPNEEQ have not been established in pediatric patients under 13 years of age.
  • 8.5 Geriatric Use Three hundred and fifteen subjects aged 65 years and older received treatment with UPNEEQ (n = 216) or vehicle (n = 99) in clinical trials.
  • No overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger subjects.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • 7.1 Anti-hypertensives/Cardiac Glycosides Alpha-adrenergic agonists, as a class, may impact blood pressure.
  • Caution in using drugs such as beta-blockers, anti-hypertensives, and/or cardiac glycosides is advised.
  • Caution should also be exercised in patients receiving alpha adrenergic receptor antagonists such as in the treatment of cardiovascular disease, or benign prostatic hypertrophy.
  • 7.2 Monoamine Oxidase Inhibitors Caution is advised in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.
  • 7.1 Anti-hypertensives/Cardiac Glycosides Alpha-adrenergic agonists, as a class, may impact blood pressure.
  • Caution in using drugs such as beta-blockers, anti-hypertensives, and/or cardiac glycosides is advised.
  • Caution should also be exercised in patients receiving alpha adrenergic receptor antagonists such as in the treatment of cardiovascular disease, or benign prostatic hypertrophy.
  • 7.2 Monoamine Oxidase Inhibitors Caution is advised in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • Accidental oral ingestion of topical intended solutions (including ophthalmic solutions and nasal sprays) containing imidazoline derivatives (e.g., oxymetazoline) in children has resulted in serious adverse events requiring hospitalization, including nausea, vomiting, lethargy, tachycardia, decreased respiration, bradycardia, hypotension, hypertension, sedation, somnolence, mydriasis, stupor, hypothermia, drooling, and coma.
  • Keep UPNEEQ out of reach of children.

Quoted from the official label, section “Overdosage”.

Use in children

Safety and effectiveness of UPNEEQ have not been established in pediatric patients under 13 years of age.

Quoted from the official label, section “Pediatric Use”.

Use in older people

  • Three hundred and fifteen subjects aged 65 years and older received treatment with UPNEEQ (n = 216) or vehicle (n = 99) in clinical trials.
  • No overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger subjects.

Quoted from the official label, section “Geriatric Use”.

Side effects

  • Most common adverse reactions (incidence 1-5%) are:
  • punctate keratitis, conjunctival hyperemia, dry eye, vision blurred, instillation site pain, eye irritation and headache.
  • ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact RVL Pharmaceuticals, Inc. at 1-877-482-3788 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.
  • A total of 360 subjects with acquired blepharoptosis were treated with UPNEEQ once daily in each eye for at least 6 weeks in three controlled Phase 3 clinical trials, including 203 subjects treated with UPNEEQ for 6 weeks and 157 subjects treated with UPNEEQ for 12 weeks.
  • Adverse reactions that occurred in 1-5% of subjects treated with UPNEEQ were punctate keratitis, conjunctival hyperemia, dry eye, blurred vision, instillation site pain, eye irritation and headache.
  • 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.
  • A total of 360 subjects with acquired blepharoptosis were treated with UPNEEQ once daily in each eye for at least 6 weeks in three controlled Phase 3 clinical trials, including 203 subjects treated with UPNEEQ for 6 weeks and 157 subjects treated with UPNEEQ for 12 weeks.
  • Adverse reactions that occurred in 1-5% of subjects treated with UPNEEQ were punctate keratitis, conjunctival hyperemia, dry eye, blurred vision, instillation site pain, eye irritation and headache.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • Advise the patient and/or caregiver to read the FDA-approved patient labeling (Instructions for Use).
  • When to Seek Medical Care Ptosis may be associated with neurologic or orbital diseases such as stroke and/or cerebral aneurysm, Horner syndrome, myasthenia gravis, external ophthalmoplegia, orbital infection and orbital masses.
  • Consideration should be given to these conditions in the presence of ptosis with decreased levator muscle function and/or other neurologic signs [see Warnings and Precautions ( 5.1 )] .
  • Alpha-adrenergic agonists as a class may impact blood pressure.
  • Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens [see Warnings and Precautions ( 5.2 )] .
  • Use with caution in patients with cerebral or coronary insufficiency or Sjögren’s syndrome and advise patients to seek medical care if signs and symptoms of potentiation of vascular insufficiency develop [see Warnings and Precautions ( 5.3 )] .
  • Advise patients to seek immediate medical care if signs and symptoms of acute narrow-angle glaucoma develop [see Warnings and Precautions ( 5.4 )] .
  • Administration Instructions Use with Contact Lenses Advise patients that contact lenses should be removed prior to administration of UPNEEQ and can be re-inserted 15 minutes following administration [see Dosage and Administration ( 2 )] .
  • Use with Other Ophthalmic Drugs If more than one topical ophthalmic drug is being used, the drugs should be administered at least 15 minutes between applications.
  • Administration Advise patients that the solution from one single patient-use container is to be used immediately after opening to dose one or both eye(s).
  • The single patient-use container, including any remaining contents, should be discarded immediately after administration [see Dosage and Administration ( 2 )] .
  • Storage and Handling Instructions Handling the Single Patient-Use Container Advise patients not to touch the tip of the single patient-use container to their eye or to any surface, in order to
  • avoid eye injury or contamination of the solution.
  • Storage Information Instruct patients to keep the single patient-use containers in the child-resistant foil pouches until ready to use.
  • Keep out of reach of children.
  • To report SUSPECTED ADVERSE REACTIONS, contact RVL Pharmaceuticals, Inc. at 1-877-482-3788 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . © 2026 RVL Pharmaceuticals, Inc.
  • All rights reserved.
  • Bridgewater, New Jersey 08807 Patents 8357714, 9867808, 10799481, 10814001, 10898573, 10912765, 10940138, 11103482, 11311515, 11324722, 11541036, 11701343, 12605363, and 12648930 Made in the U.S.A.
  • Manufactured for: RVL Pharmaceuticals, Inc.
  • PLR-UPN-00007-10 IC # 2284

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

  • FORMS AND STRENGTHS UPNEEQ (oxymetazoline hydrochloride ophthalmic solution), 0.1%, equivalent to 0.09% as oxymetazoline base, is formulated for topical ocular delivery as a sterile, non-preserved, clear, colorless to slightly yellow ophthalmic solution.
  • Ophthalmic solution, 0.1% oxymetazoline as salt, equivalent to 0.09% oxymetazoline as base.
  • ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

  • UPNEEQ (oxymetazoline hydrochloride ophthalmic solution), 0.1% is an aseptically prepared, sterile, non-preserved, clear, colorless to slightly yellow ophthalmic solution; 0.3 mL fill in a clear, low-density polyethylene, single patient-use container in a child-resistant foil pouch.
  • NDC 73687-062-32 Carton of 30 single patient-use containers in individual child-resistant foil pouches.
  • Storage: Store at 20°C to 25°C (68°F to 77°F).
  • Protect from excessive heat.
  • Keep out of reach of children.
  • Store single patient-use containers in the child-resistant foil pouches.
  • Opened containers should be discarded immediately after use.

Quoted from the official label, section “How Supplied”.

What is in it

  • UPNEEQ (oxymetazoline hydrochloride ophthalmic solution), 0.1% contains oxymetazoline hydrochloride, an alpha adrenoceptor agonist.
  • UPNEEQ is an aseptically prepared, sterile, non-preserved ophthalmic solution.
  • The chemical name is 6-tert-Butyl-3-(2-imidazolin-2-ylmethyl)-2,4- dimethylphenol monohydrochloride, and the molecular mass is 296.84.
  • Oxymetazoline HCl is freely soluble in water and ethanol and has a partition coefficient of 0.1 in 1-octanol/water.
  • The molecular formula of oxymetazoline HCl is C 16 H 24 N 2 O∙HCl, and its structural formula is:
  • Each mL of UPNEEQ (oxymetazoline hydrochloride ophthalmic solution) 0.1% contains 1 mg of oxymetazoline hydrochloride, equivalent to 0.9 mg (0.09%) of oxymetazoline free base.
  • The ophthalmic solution contains the following inactive ingredients:
  • calcium chloride, hydrochloric acid (used to adjust pH to 5.8 to 6.8), hypromellose, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium citrate, and water for injection.
  • Oxymetazoline Structural Formula

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

This label’s list of inactive ingredients names none of: lactose, wheat or gluten, colour dyes, sugars, sugar alcohols, alcohol (ethanol), aspartame (phenylalanine), gelatin, peanut oil, soy, parabens, sulfites, titanium dioxide.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

CanadaNo exact match for this strength and form

Every strength and form (21)

Details

Made byRVL Pharmaceuticals, Inc.
Active substanceOxymetazoline Hydrochloride Ophthalmic
Strength1 mg/mL
FormSolution/ Drops
RouteOphthalmic
Packs30 AMPULE in 1 CARTON / .3 mL in 1 AMPULE · 5 AMPULE in 1 CARTON / .3 mL in 1 AMPULE
NDC73687-062

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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