sinuva
Pharmaranks rates Sinuva 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Sinuva (Mometasone Furoate) is a corticosteroid used to treat Facial Dermatoses, Foot Dermatoses, Hand Dermatoses, Inflammation.
Mometasone Furoate · by Intersect Ent Inc
Available as a generic: Mometasone Furoate
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
- Mometasone Furoate
- Drug class
- Corticosteroid
- Form
- Implant
- Strength
- Mometasone Furoate 1.35MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- facial dermatoses, foot dermatoses, hand dermatoses
- Manufacturer
- Intersect Ent Inc
- What the pharmacy pays
- ~$0.41 per gm — not your price
- FDA application
- NDA209310
What is Sinuva?
From the FDA label:The SINUVA Sinus Implant is a self-expanding, bioabsorbable, drug eluting implant provided with a crimper and a single-use delivery system. SINUVA Sinus Implant is comprised of poly(L-lactide-co-glycolide) and poly(L-lactide-co-⃞-caprolactone) coated with mometasone furoate embedded in a bioabsorbable polymer matrix containing poly(DL-lactide-co-glycolide) and polyethylene glycol (inactive ingredients) which provides for gradual release of the drug. The SINUVA Sinus Implant is packaged in a tray, which is then sealed in a foil pouch and placed in the product carton. The SINUVA Sinus Implant is provided sterile. Mometasone furoate, the active component of the SINUVA Sinus Implant, is a corticosteroid with the chemical name 9,21-dichloro-11(⃞),17-dihydroxy-16(⃞)-methylpregna-1,4-diene-3,20- dione 17 (2-furoate). Mometasone furoate is a white powder with an empirical formula of C 27 H 30 Cl 2 O 6 , and molecular weight of 521.44 Daltons. The chemical structure of mometasone furoate is shown below: The inactive ingredients are poly-(DL-lactide-co-glycolide) and polyethylene glycol. Poly-(DL-lactide-co-glycolide) is an amorphous biodegradable polymer. Chemical Structure
How to use
The SINUVA Sinus Implant is loaded into a Delivery System and placed in the ethmoid sinus under endoscopic visualization. The Implant may be left in the sinus to gradually release the corticosteroid over 90 days. Remove the implant by 90 days or earlier at the physician's discretion using standard surgical instruments. ( 2.2 ) To be inserted by physicians trained in otolaryngology. ( 2.3 ) 2.1 Recommended Dosage The recommended dosage is one SINUVA Sinus Implant (1350 mcg of mometasone furoate) placed in an ethmoid sinus [see Dosage and Administration (2.3) ] . The SINUVA Sinus Implant may be left in the sinus to gradually release the corticosteroid over 90 days. Remove the SINUVA Sinus Implant by 90 days or earlier at the physician's discretion [see Dosage and Administration (2.4) ] . 2.2 Health Care Provider Training The SINUVA Sinus Implant is to be used by physicians trained in otolaryngology. Specialized training is not required for these physicians . 2.3 Placement of SINUVA Sinus Implant The SINUVA Sinus Implant is designed for single patient use only. Do not reprocess or reuse. Do not use if the package is open, the package or product is damaged, or has evidence of gross contamination. Special care should be taken to avoid bending, twisting, or damaging the implant. The implant is not designed to be modified by the physician. The implant is not intended to be compressed…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Local Nasal Adverse Reactions [see Warnings and Precautions (5.1) ] Glaucoma and Cataracts [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Immunosuppression and Risk of Infections [see Warnings and Precautions (5.4) ] Hypercorticism and Adrenal Suppression [see Warnings and Precautions (5.5) ] The most common adverse reactions (in more than 1% of subjects) were bronchitis, nasopharyngitis, otitis media, headache, presyncope, asthma, and epistaxis. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Intersect ENT at 1-866 531-6004 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. The safety of the SINUVA Sinus Implant was evaluated and demonstrated in 400 patients in 2 controlled, randomized, parallel group, single-blind studies. In Study 1, one-hundred (100) subjects were followed for 6 months. In Study 2, three-hundred (300) subjects were followed for 90 days. Of the 400 patients, 254 were assigned to the treatment group and underwent…
Warnings
Important safety information
Monitor nasal mucosa adjacent to the SINUVA Sinus Implant for any signs of bleeding (epistaxis), irritation, infection, or perforation. Avoid use in patients with nasal ulcers or trauma. ( 5.1 ) Monitor patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts closely. ( 5.2 ) Hypersensitivity reactions, including rash, pruritus, and angioedema, have been reported with use of corticosteroids. ( 5.3 ) Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with the above because of the potential for worsening of these infections. ( 5.4 ) If corticosteroid effects such as hypercorticism and adrenal suppression appear in patients, consider sinus implant removal. ( 5.5 ) 5.1 Local Nasal Adverse Reactions Monitor nasal mucosa adjacent to the SINUVA Sinus Implant for any signs of bleeding (epistaxis), irritation, infection, or perforation. Avoid use in patients with nasal ulcers or trauma. 5.2 Glaucoma and Cataracts Nasal steroids may result in development of glaucoma and/or cataracts. Glaucoma, cataracts, and clinically significant elevation of intraocular pressure were not observed in patients from the treatment group of one randomized controlled clinical study (N = 53) who underwent bilateral placement of SINUVA Sinus Implants. Close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts. 5.3 Hypersensitivity Reactions Hypersensitivity reactions, including rash, pruritus, and angioedema have been reported with use of corticosteroids. 5.4 Immunosuppression and Risk of Infections Persons who are using drugs that suppress the immune system, such as corticosteroids, including SINUVA Sinus Implant are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In such children or adults who have not had these diseases or who are not properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The safety and effectiveness of SINUVA Sinus Implant have not been established in pediatric patients less than 18 years of age and SINVA is not indicated for use in this population. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated (See the respective Prescribing Information for VZIG and IG). If chickenpox develops, treatment with antiviral agents may be considered. Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. 5.5 Hypercorticism and Adrenal Suppression Hypercorticism and adrenal suppression were not evaluated as part of the SINUVA Sinus Implant clinical program. Since individual sensitivity to effects of cortisol production exists, physicians should consider this information when prescribing SINUVA Sinus Implant. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response. It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear in patients, particularly when systemic mometasone furoate is administered at higher than recommended doses over prolonged periods of time. If such effects occur, consider sinus implant removal.
Who should not take Sinuva
Patients with known hypersensitivity to mometasone furoate, or to any of the copolymers of the SINUVA Sinus Implant [see Description (11) ] . Patients with known hypersensitivity to mometasone furoate and any of the ingredients of the SINUVA Sinus Implant . ( 4 )
Overdose — what happens if you take too much
There are no data available on the effects of acute or chronic overdosage with SINUVA Sinus Implant. Chronic overdosage may result in signs/symptoms of hypercorticism [see Warnings and Precautions (5.5) ] .
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
Formal drug-drug interaction studies have not been conducted with the SINUVA Sinus Implant. An evaluation of the concurrent administration of the SINUVA Sinus Implant and other commonly used nasal drugs was not associated with any unusual adverse reactions. 7.1 Inhibitors of Cytochrome P450 3A4 Co-administration with ketoconazole, a potent CYP 3A4 inhibitor, may increase the plasma concentrations of mometasone furoate [see Clinical Pharmacology (12.3) ] .
Drug class
How this class works, per Corticosteroids - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Sinuva ranks — best-rated corticosteroid for:
Dosage forms
Implant
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.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Sinuva treat?
- Sinuva (Mometasone Furoate) may be used to treat facial dermatoses, foot dermatoses, hand dermatoses, inflammation, leg dermatoses, pruritus, 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 Sinuva work?
- Sinuva is a corticosteroid. Corticosteroids mimic the body's natural stress hormone cortisol: they enter cells and bind a glucocorticoid receptor that switches off genes for inflammatory chemicals, calming swelling, redness, and an overactive immune response.
- How is Sinuva rated?
- pharmaranks gives Sinuva 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.
- How much does Sinuva cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.41 per gm, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Cortenema — about $0.14 on the same basis.
- Is there a coupon or discount for Sinuva?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Sinuva. 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 Sinuva?
- Sinuva is marketed by Intersect Ent Inc. You can see Intersect Ent Inc's full profile, rating, and other products on pharmaranks.
- Is Sinuva a brand-name or generic drug?
- Sinuva is a brand-name product with the active ingredient Mometasone Furoate. Lower-cost generic equivalents containing Mometasone Furoate are available — ask your pharmacist.
- Is Sinuva available over the counter?
- No. Sinuva 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 Sinuva come in?
- Sinuva is currently marketed as implant, per the FDA's National Drug Code Directory.
- What class of drug is Sinuva?
- Sinuva is classified as corticosteroid, per the FDA's Established Pharmacologic Class.
- Is Sinuva FDA-registered?
- Sinuva is on record with the U.S. FDA under application number NDA209310. You can verify this on its official FDA label.
- Has Sinuva been recalled by the FDA?
- Yes. Sinuva has 1 recorded FDA recall event 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 Sinuva safe?
- There's no single safe-or-not verdict. pharmaranks gives Sinuva a recall-safety score of 70/100, based on its FDA recall history (1 recorded recall event) — 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 Sinuva?
- Sinuva's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: Local Nasal Adverse Reactions [see Warnings and Precautions (5.1) ] Glaucoma and Cataracts [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Immunosupp… 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 MOMETASONE FUROATE
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 13,044 reports naming MOMETASONE FUROATE — the active ingredient in Sinuva, and the FDA flagged 72% 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:
- dyspnoea1,690 reports
- asthma1,631 reports
- wheezing1,133 reports
- cough1,110 reports
- headache1,027 reports
- fatigue875 reports
- pneumonia806 reports
- therapeutic product effect incomplete776 reports
Read these as a signal, not a rate. A report does not mean MOMETASONE FUROATE 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 25, 2026.
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sinuva
70/100