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LATISSE bimatoprost .3 mg/mL Solution/ Drops — NDC 00023-3616-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

LATISSE bimatoprost .3 mg/mL Solution/ Drops — NDC 0023-3616-05 (Billing 00023-3616-05)

by Allergan, Inc. · 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER

This is a package of LATISSE bimatoprost .3 mg/mL Solution/ Drops from Allergan, Inc., marketed since Jan 2009 and currently FDA-listed; retail pharmacies pay about $31.49 per mL (NADAC). It is the main listing for this product, which comes in 3 package sizes.

NDC 00023-3616-05
🏷️ FDA NDC (as labeled) 0023-3616-05 billing pads the labeler segment with a zero
This package
Contains5 mL in 1 bottle, dropper Cost per mL$31.49 NADAC Per package$157.45 / 5 ml Pack sizes3 compare ↓
Main listing for product 0023-3616 · Also comes in: 3 mL 0023-3616-70 3 mL 0023-3616-71
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0023-3616-05 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0023 labeler · 3616 product · 05 package
Package marketed since
Jan 26, 2009
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0023361605 5
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0023-3616-05
Product NDC 0023-3616
11-digit billing NDC 00023361605
NCPDP billing unit ML — per mL (volume)
RxCUI 1041495, 1041497
UNII QXS94885MZ
Application # NDA022369
SPL Set ID 34f83d9d-2c64-463e-8a90-9a460fedfead
Established class (EPC) Prostaglandin Analog
Chemical class Prostaglandins
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-01-26
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance BIMATOPROST
TE code (Orange Book) AT · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90734020002020
GPI class Latisse
GCN Seq No 064746
GCN 16219
HICL code 022000
Ingredient (HICL) Bimatoprost
HIC1 code T
Therapeutic class — broad (HIC1) Ear,Eye,Nose,Rectum,Top,Vag.,Spec.senses(Q Cont.)
HIC2 code T0
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin (Q5 Cont'd)
HIC3 code T0D
Therapeutic class — specific (HIC3) Topical Hypertrichotic Agents, Eyelashes
AHFS code 52:40.28.00
AHFS class Prostaglandin Analogs
FDB label name LATISSE 0.03% EYELASH SOLUTION
FDB brand name Latisse
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 064746
  • GCN: 16219
  • GPI-14 (Medi-Span): 90734020002020
  • HICL (First Databank): 022000
  • AHFS class code: 52:40.28.00
  • RxCUI (RxNorm): 1041495
Why two NDCs? The FDA registers this code as 0023-3616-05 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00023-3616-05. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Prostaglandin Analog class.

Pharmacologic class Prostaglandin Analog
Drug family (ATC) Prostaglandin analogues
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name LATISSE 0.03% EYELASH SOLUTION Ingredient Bimatoprost
📗 Our plain-language guide HelloPharmacist
  • Bimatoprost ophthalmic 0.03% is used to grow longer, thicker and darker eyelashes if you have hypotrichosis, meaning sparse lashes. Lumigan is a related bimatoprost eye drop used f...
  • Do it once at night on a clean face with makeup and contacts out. Put one drop on the sterile applicator and brush it along the upper lid at the base of the lashes. Blot extra, and...
  • No. Extra applications will not increase growth. If you stop, your lashes are expected to return to how they were before treatment.
  • Will using more make my lashes grow more?
📖 Read our full Bimatoprost Ophthalmic guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Bimatoprost — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Bimatoprost (3 interactions) — ranked by severity →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $31.491 $157.45 / 5 ml
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Feb 2021 Jan 2026 May 2026 Sep 2026 $31.585 $31.431
Flat over the last 12 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00023-3616-05 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER $31.49 / mL $157.45 2009-01-26 — Active
00023-3616-70 0023-3616-70 1 BOTTLE, DROPPER in 1 CARTON / 3 mL in 1 BOTTLE, DROPPER $40.98 / mL $122.93 2009-01-26 — Active
00023-3616-71 0023-3616-71 1 BOTTLE, DROPPER in 1 CARTON / 3 mL in 1 BOTTLE, DROPPER Sample — — 2009-01-26 — Active

This pack has the lowest per-mL cost of the 2 priced pack sizes ($31.49 NADAC).

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of LATISSE bimatoprost .3 mg/mL Solution/ Drops?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bimatoprost .3 mg/mL 72266-0241-01 Fosun 1 bottle $4.207 AT Availability likely save 87%
Bimatoprost .3 mg/mL 70069-0403-01 Somerset 1 bottle $4.207 AT Availability likely save 87%
Bimatoprost .3 mg/mL 70069-0401-01 Somerset 1 bottle $6.969 AT Availability likely save 78%
Bimatoprost .3 mg/mL 72266-0139-01 Fosun 1 bottle $6.969 AT Availability likely save 78%
Bimatoprost .3 mg/mL 65862-0802-05 Aurobindo 1 bottle $8.852 AT Availability likely save 72%
Bimatoprost .3 mg/mL 72266-0140-01 Fosun 1 bottle $8.852 AT Availability likely save 72%
Bimatoprost .3 mg/mL 60505-0583-01 Apotex 1 bottle $8.852 AT Availability likely save 72%
Bimatoprost .3 mg/mL 62332-0507-05 Alembic 1 bottle $8.852 AT Availability likely save 72%
Bimatoprost .3 mg/mL 42571-0128-21 Micro 1 bottle $8.852 AT Availability likely save 72%
Bimatoprost .3 mg/mL 70069-0402-01 Somerset 1 bottle $8.852 AT Availability likely save 72%
Bimatoprost .3 mg/mL 00781-6206-75 Sandoz 1 bottle $20.649 AT Availability likely save 34%
bimatoprost .3 mg/mL 62332-0511-03 Alembic 1 bottle $26.274 AT Availability likely save 17%
Latisse .3 mg/mLthis 00023-3616-05 Allergan, 1 bottle $31.491 AT Availability likely —
Bimatoprost .3 mg/mL 68083-0295-01 Gland 1 bottle — AT FDA listed —
Bimatoprost .3 mg/mL 68083-0296-01 Gland 1 bottle — AT FDA listed —
Bimatoprost .3 mg/mL 68083-0439-01 Gland 1 bottle — AT FDA listed —
Bimatoprost .3 mg/mL 46708-0507-05 Alembic 1 bottle — AT FDA listed —
bimatoprost .3 mg/mL 46708-0511-03 Alembic 1 bottle — AT FDA listed —
Bimatoprost .3 mg/mL 68071-3590-05 NuCare 1 bottle — AT FDA listed —
Bimatoprost .3 mg/mL 68071-3612-05 NuCare 1 bottle — AT FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2009
On the market since
Jan 2009
📍
2026
Currently FDA-listed
17 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAllergan, Inc.
Application holderABBVIE INC
FDA applicationNDA022369 (NDA)
Labeler code00023
First marketedJan 2009
Product typeHuman Prescription Drug
Portfolio188 products on file

More NDCs from Allergan, Inc. labeler code 00023

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 52 words ▾

1 INDICATIONS AND USAGE LATISSE ® (bimatoprost ophthalmic solution) 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. LATISSE ® is a prostaglandin analog, indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. ( 1 )

⏱️ Dosage and Administration 220 words ▾

2 DOSAGE AND ADMINISTRATION Ensure the face is clean, makeup and contact lenses are removed. Once nightly, place one drop of LATISSE ® (bimatoprost ophthalmic solution) 0.03% on the disposable sterile applicator supplied with the package and apply evenly along the skin of the upper eyelid margin at the base of the eyelashes. The upper lid margin in the area of lash growth should feel lightly moist without runoff.

Blot any excess solution runoff outside the upper eyelid margin with a tissue or other absorbent cloth. Dispose of the applicator after one use. Repeat for the opposite eyelid margin using a new sterile applicator.

Do not reuse applicators and do not use any other brush/applicator to apply LATISSE ® . Do not apply to the lower eyelash line [see Warnings and Precautions ( 5.3 , 5.4 ) and Patient Counseling Information (17) ] . Additional applications of LATISSE ® will not increase the growth of eyelashes.

Upon discontinuation of treatment, eyelash growth is expected to return to its pre-treatment level. Apply nightly directly to the skin of the upper eyelid margin at the base of the eyelashes using the accompanying applicators. Blot any excess solution beyond the eyelid margin.

Dispose of the applicator after one use. Repeat for the opposite eyelid margin using a new sterile applicator. ( 2 )

💊 Dosage Forms and Strengths 20 words ▾

3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution containing bimatoprost 0.3 mg/mL. Ophthalmic solution containing bimatoprost 0.3 mg/mL. ( 3 )

⛔ Contraindications 28 words ▾

4 CONTRAINDICATIONS LATISSE ® is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [ see Adverse Reactions (6.2) ]. Hypersensitivity. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Concurrent administration of LATISSE ® and intraocular pressure (IOP)-lowering prostaglandin analogs in ocular hypertensive patients may decrease the IOP-lowering effect. Patients using these products concomitantly should be closely monitored for changes to their IOP. ( 5.1 ) Pigmentation of the eyelids and iris may occur. Iris pigmentation is likely to be permanent. ( 5.2 , 5.3 )

5.1Effects on Intraocular Pressure Bimatoprost ophthalmic solution ( LUMIGAN ® ) lowers intraocular pressure (IOP) when instilled directly to the eye in patients with elevated IOP. In clinical trials, in patients with or without elevated IOP, LATISSE ® lowered IOP, however, the magnitude of the reduction was not cause for clinical concern. In ocular hypertension studies with LUMIGAN ® , it has been shown that exposure of the eye to more than one dose of bimatoprost daily may decrease the intraocular pressure lowering effect.

In patients using LUMIGAN ® or other prostaglandin analogs for the treatment of elevated intraocular pressure, the concomitant use of LATISSE ® may interfere with the desired reduction in IOP. Patients using prostaglandin analogs including LUMIGAN ® for IOP reduction should only use LATISSE ® after consulting with their physician and should be monitored for changes to their intraocular pressure.

5.2Iris Pigmentation Increased iris pigmentation has occurred when bimatoprost solution was administered. Patients should be advised about the potential for increased brown iris pigmentation which is likely to be permanent [see Adverse Reactions (6.2) ] . The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes.

The long term effects of increased pigmentation are not known. Iris color changes seen with administration of bimatoprost ophthalmic solution may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish.

Neither nevi nor freckles of the iris appear to be affected by treatment. Treatment with LATISSE ® solution can be continued in patients who develop noticeably increased iris pigmentation.

5.3Lid Pigmentation Bimatoprost has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes. The pigmentation is expected to increase as long as bimatoprost is administered, but has been reported to be reversible upon discontinuation of bimatoprost in most patients.

5.4Hair Growth Outside the Treatment Area There is the potential for hair growth to occur in areas where LATISSE ® solution comes in repeated contact with the skin surface. It is important to apply LATISSE ® only to the skin of the upper eyelid margin at the base of the eyelashes using the accompanying sterile applicators, and to carefully blot any excess LATISSE ® from the eyelid margin to avoid it running onto the cheek or other skin areas.

5.5Intraocular Inflammation LATISSE ® solution should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.

5.6Macular Edema Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost ophthalmic solution ( LUMIGAN ® ) for elevated IOP. LATISSE ® should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

5.7Contamination of LATISSE ® or Applicators The LATISSE ® bottle must be kept intact during use. It is important to use LATISSE ® solution as instructed, by placing one drop on the single-use-per-eye applicator. The bottle tip should not be allowed to contact any other surface since it could become contaminated.

The accompanying sterile applicators should only be used on one eye and then discarded since reuse of ap… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: Effects on Intraocular Pressure [ see Warnings and Precautions (5.1) ] Iris Pigmentation [ see Warnings and Precautions (5.2) ] Lid Pigmentation [ see Warnings and Precautions (5.3) ] Hair Growth Outside the Treatment Area [ see Warnings and Precautions (5.4) ] Intraocular Inflammation [ see Warnings and Precautions (5.5) ] Macular Edema [ see Warnings and Precautions (5.6) ] Hypersensitivity [ see Contraindications (4) ] Most common adverse reactions (incidence approximately 3% to 4%) are eye pruritus, conjunctival hyperemia, and skin hyperpigmentation.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial 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 following information is based on clinical trial results from a multicenter, double-masked, randomized, vehicle-controlled, parallel study including 278 adult patients for four months of treatment. The most frequently reported adverse reactions were eye pruritus, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry eye symptoms, and periorbital erythema.

These reactions occurred in less than 4% of patients. Additional adverse reactions seen in clinical trials experience include foreign body sensation, hair growth abnormal, and iris hyperpigmentation. Additional adverse reactions reported with bimatoprost ophthalmic solution ( LUMIGAN ® ) for the reduction of intraocular pressure include, ocular dryness, visual disturbance, ocular burning, eye pain, blepharitis, cataract, superficial punctate keratitis, eye discharge, tearing, photophobia, allergic conjunctivitis, asthenopia, conjunctival edema, iritis, infections (primarily colds and upper respiratory tract infections), headaches, and asthenia.

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of LATISSE ® . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The reactions include dry skin of the eyelid and/or periocular area, eye swelling, eyelid edema, hordeolum, hypersensitivity (local allergic reactions), lacrimation increased, madarosis and trichorrhexis (temporary loss of a few lashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively), periorbital and lid changes associated with periorbital fat atrophy and skin tightness resulting in deepening of eyelid sulcus and eyelid ptosis, rash (including macular and erythematous), skin discoloration (periorbital), skin exfoliation of the eyelid and/or periorbital area, trichiasis, and vision blurred.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of LATISSE ® (bimatoprost ophthalmic solution) 0.03% administration in pregnant women. There is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. In embryofetal development studies, administration of bimatoprost to pregnant mice and rats during organogenesis resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on the area under the curve (AUC).

These adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC. In pre/postnatal development studies, administration of bimatoprost to pregnant rats from organogenesis to the end of lactation resulted in reduced gestation length and fetal body weight, and increased fetal and pup mortality at oral doses at least 41 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC.

No adverse effects were observed in rat offspring at exposures estimated at 14 times the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC. Because animal reproductive studies are not always predictive of human response LATISSE ® 0.03% should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data Animal Data In an embryofetal development rat study, abortion was observed in pregnant rats administered bimatoprost orally during organogenesis at 0.6 mg/kg/day (94 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC).

The No Observed Adverse Effect Level (NOAEL) for abortion was 0.3 mg/kg/day (estimated at 47 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily based on AUC). No abnormalities were observed in rat fetuses at doses up to 0.6 mg/kg/day. In an embryofetal development mouse study, abortion and early delivery were observed in pregnant mice administered bimatoprost orally during organogenesis at doses greater than or equal to 0.3 mg/kg/day (33 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC).

The NOAEL for abortion and early delivery was 0.1 mg/kg/day (2.6 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC). No abnormalities were observed in mouse fetuses at doses up to 0.6 mg/kg/day (72 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC). In a pre/postnatal development study, treatment of pregnant rats with bimatoprost orally from gestation day 7 to lactation day 20 resulted in reduced gestation length, increased late resorptions, fetal deaths, and postnatal pup mortality, and reduced pup body weight at doses greater than or equal to 0.3 mg/kg/day.

These effects were observed at exposures at least 41 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC. The NOAEL for postnatal development and mating performance of the offspring was 0.1 mg/kg/da… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of LATISSE ® (bimatoprost ophthalmic solution) 0.03% administration in pregnant women. There is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. In embryofetal development studies, administration of bimatoprost to pregnant mice and rats during organogenesis resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on the area under the curve (AUC).

These adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC. In pre/postnatal development studies, administration of bimatoprost to pregnant rats from organogenesis to the end of lactation resulted in reduced gestation length and fetal body weight, and increased fetal and pup mortality at oral doses at least 41 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC.

No adverse effects were observed in rat offspring at exposures estimated at 14 times the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC. Because animal reproductive studies are not always predictive of human response LATISSE ® 0.03% should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data Animal Data In an embryofetal development rat study, abortion was observed in pregnant rats administered bimatoprost orally during organogenesis at 0.6 mg/kg/day (94 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC).

The No Observed Adverse Effect Level (NOAEL) for abortion was 0.3 mg/kg/day (estimated at 47 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily based on AUC). No abnormalities were observed in rat fetuses at doses up to 0.6 mg/kg/day. In an embryofetal development mouse study, abortion and early delivery were observed in pregnant mice administered bimatoprost orally during organogenesis at doses greater than or equal to 0.3 mg/kg/day (33 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC).

The NOAEL for abortion and early delivery was 0.1 mg/kg/day (2.6 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC). No abnormalities were observed in mouse fetuses at doses up to 0.6 mg/kg/day (72 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC). In a pre/postnatal development study, treatment of pregnant rats with bimatoprost orally from gestation day 7 to lactation day 20 resulted in reduced gestation length, increased late resorptions, fetal deaths, and postnatal pup mortality, and reduced pup body weight at doses greater than or equal to 0.3 mg/kg/day.

These effects were observed at exposures at least 41 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC. The NOAEL for postnatal development and mating performance of the offspring was 0.1 mg/kg/day (estimated at 14 times the h… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 130 words ▾

8.4Pediatric Use Use of LATISSE ® was evaluated in a sixteen-week double-masked, randomized, vehicle-controlled study conducted in pediatric patients who were post-chemotherapy or had alopecia areata, and adolescents who had hypotrichosis with no associated medical condition. No new safety issues were observed. The results of the Global Eyelash Assessment (GEA) are provided in Table 1.

Table 1. Number (%) of subjects with at least a 1-grade increase from baseline at month 4 in Global Eyelash Assessment Age Range (years) LATISSE ® Vehicle Difference (95% CI) Adolescents with hypotrichosis (N=40) 15 - 17 19/26 (73%) 1/14 (7%) 66% (44%, 88%) Post Chemotherapy Pediatric Patients (N=16) 5 - 17 11/13 (85%) 3/3 (100%) -15% (-35%, 4%) Alopecia Areata Pediatric Patients (N=15) 5 - 17 4/9 (44%) 2/6 (33%) 11% (-39%, 61%)

🧓 Geriatric Use 20 words ▾

8.5Geriatric Use No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Bimatoprost is a structural prostaglandin analog. Although the precise mechanism of action is unknown, the growth of eyelashes is believed to occur by increasing the percent of hairs in, and the duration of the anagen or growth phase.

12.3Pharmacokinetics Absorption After one drop of bimatoprost ophthalmic solution 0.03% was administered once daily into both eyes (cornea and/or conjunctival sac) of 15 healthy subjects for two weeks, blood concentrations peaked within 10 minutes after dosing and were below the lower limit of detection (0.025 ng/mL) in most subjects within 1.5 hours after dosing. Mean C max and AUC 0-24hr values were similar on days 7 and 14 at approximately 0.08 ng/mL and 0.09 ng●hr/mL, respectively, indicating that steady state was reached during the first week of ocular dosing.

There was no significant systemic drug accumulation over time. Distribution Bimatoprost is moderately distributed into body tissues with a steady-state volume of distribution of

0.67L/kg. In human blood, bimatoprost resides mainly in the plasma. Approximately 12% of bimatoprost remains unbound in human plasma.

Elimination Metabolism Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation. Bimatoprost then undergoes oxidation, N-deethylation, and glucuronidation to form a diverse variety of metabolites. Excretion Following an intravenous dose of radiolabeled bimatoprost (3.12 mcg/kg) to six healthy subjects, the maximum blood concentration of unchanged drug was 12.2 ng/mL and decreased rapidly with an elimination half-life of approximately 45 minutes.

The total blood clearance of bimatoprost was

1.5L/hr/kg. Up to 67% of the administered dose was excreted in the urine while 25% of the dose was recovered in the feces.

🧬 Mechanism of Action 42 words ▾

12.1Mechanism of Action Bimatoprost is a structural prostaglandin analog. Although the precise mechanism of action is unknown, the growth of eyelashes is believed to occur by increasing the percent of hairs in, and the duration of the anagen or growth phase.

📦 How Supplied / Storage and Handling 65 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING LATISSE ® (bimatoprost ophthalmic solution) 0.03% is supplied sterile in opaque white low-density polyethylene dispenser bottles and tips with turquoise polystyrene caps accompanied by sterile, disposable applicators: 3 mL in a 5 mL bottle with 70 applicators NDC 0023-3616-70 5 mL in a 5 mL bottle with 140 applicators NDC 0023-3616-05 Storage: Store at 2º to 25ºC (36º to 77ºF).

📋 Description 136 words ▾

11 DESCRIPTION LATISSE ® (bimatoprost ophthalmic solution) 0.03% is a synthetic prostaglandin analog. Its chemical name is ( Z )-7-[(1 R ,2 R ,3 R ,5 S )-3,5-Dihydroxy-2-[(1 E ,3 S )-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]- N -ethyl-5-heptenamide, and its molecular weight is 415.58. Its molecular formula is C 25 H 37 NO 4 .

Its chemical structure is: Bimatoprost is a powder, which is very soluble in ethyl alcohol and methyl alcohol and slightly soluble in water. LATISSE ® is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Contains: Active: bimatoprost 0.3 mg/mL; Preservative: benzalkonium chloride 0.05 mg/mL; Inactives: sodium chloride; sodium phosphate, dibasic; citric acid; and purified water.

Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8 - 7.8. chemical structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Nightly Application Inform patients that LATISSE ® (bimatoprost ophthalmic solution) should be applied every night using only the accompanying sterile applicators. They should start by ensuring their face is clean, all makeup is removed, and their contact lenses removed (if applicable).

Then, carefully place one drop of LATISSE ® solution on the disposable sterile applicator and brush cautiously along the skin of the upper eyelid margin at the base of the eyelashes. If any LATISSE ® solution gets into the eye proper, it will not cause harm. The eye should not be rinsed.

Additional applications of LATISSE ® will not increase the growth of eyelashes. Inform patients not to apply to the lower eyelash line. Any excess solution outside the upper eyelid margin should be blotted with a tissue or other absorbent material.

The onset of effect is gradual but is not significant in the majority of patients until 2 months. Counsel patients that the effect is not permanent and can be expected to gradually return to the original level upon discontinuation of treatment with LATISSE ® . Handling the Bottle and Applicator Instruct patients that the LATISSE ® bottle must be maintained intact and to avoid allowing the tip of the bottle or applicator to contact surrounding structures, fingers, or any other unintended surface in order to avoid contamination of the bottle or applicator by common bacteria known to cause ocular infections.

Instruct patients to only use the applicator supplied with the product once and then discard since reuse could result in using a contaminated applicator. Serious infections may result from using contaminated solutions or applicators. Potential for Intraocular Pressure Effects LATISSE ® may lower intraocular pressure although not to a level that will cause clinical harm.

In patients using LUMIGAN ® or other prostaglandin analogs for the treatment of elevated intraocular pressure, the concomitant use of LATISSE ® may interfere with the desired reduction in IOP. Patients using prostaglandin analogs for IOP reduction should only use LATISSE ® after consulting with their physician. Potential for Eyelid Skin Darkening Inform patients about the possibility of eyelid skin darkening, which may be reversible after discontinuation of LATISSE ® .

Potential for Iris Darkening Advise patients about the potential for increased brown iris pigmentation which is likely to be permanent. Increased iris pigmentation has occurred when bimatoprost solution was administered. Potential for Unexpected Hair Growth or Eyelash Changes Inform patients of the possibility of hair growth occurring outside of the target treatment area if LATISSE ® repeatedly touches the same area of skin outside the treatment area.

They should also be informed of the possibility of disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are likely reversible upon discontinuation of treatment. When to Seek Physician Advice Advise patients that if they develop a new ocular condition (e.g., trauma or infection), experience a sudden decrease in visual acuity, have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician’s advice concerning the continued use of LATISSE ® .

Patients on IOP-lowering medications should not use LATISSE ® without prior consultation with their physician. Contact Lens Use Advise patients that LATISSE ® solution contains benzalkonium chloride, which may be absorbed by and cause discoloration of soft contact lenses. Contact lenses should be removed prior to application of LATISSE ® and may be reinserted 15 minutes following its administration.

Distributed by: AbbVie Inc. North Chicago, IL 60064 © 2024 AbbVie. All rights reserved.

LATISSE and its design… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Absorption After one drop of bimatoprost ophthalmic solution 0.03% was administered once daily into both eyes (cornea and/or conjunctival sac) of 15 healthy subjects for two weeks, blood concentrations peaked within 10 minutes after dosing and were below the lower limit of detection (0.025 ng/mL) in most subjects within 1.5 hours after dosing. Mean C max and AUC 0-24hr values were similar on days 7 and 14 at approximately 0.08 ng/mL and 0.09 ng●hr/mL, respectively, indicating that steady state was reached during the first week of ocular dosing.

There was no significant systemic drug accumulation over time. Distribution Bimatoprost is moderately distributed into body tissues with a steady-state volume of distribution of

0.67L/kg. In human blood, bimatoprost resides mainly in the plasma. Approximately 12% of bimatoprost remains unbound in human plasma.

Elimination Metabolism Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation. Bimatoprost then undergoes oxidation, N-deethylation, and glucuronidation to form a diverse variety of metabolites. Excretion Following an intravenous dose of radiolabeled bimatoprost (3.12 mcg/kg) to six healthy subjects, the maximum blood concentration of unchanged drug was 12.2 ng/mL and decreased rapidly with an elimination half-life of approximately 45 minutes.

The total blood clearance of bimatoprost was

1.5L/hr/kg. Up to 67% of the administered dose was excreted in the urine while 25% of the dose was recovered in the feces.

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES LATISSE ® solution was evaluated for its effect on overall eyelash prominence in a multicenter, double-masked, randomized, vehicle-controlled, parallel study including 278 adult patients for four months of treatment. The primary efficacy endpoint in this study was an increase in overall eyelash prominence as measured by at least a 1-grade increase on the 4-point Global Eyelash Assessment (GEA) scale, from baseline to the end of the treatment period (week 16). LATISSE ® was more effective than vehicle as measured by the GEA score, with statistically significant differences seen at 8-week, 12-week, and 16-week ( primary endpoint ) treatment durations.

Table 2. Number (%) of subjects with at least a 1-grade increase from baseline in Global Eyelash Assessment (Primary Efficacy Endpoint – Week 16) Week LATISSE ® N=137 N (%) Vehicle N=141 N (%) 1 7 (5%) 3 (2%) 4 20 (15%) 11 (8%) 8 69 (50%) 21 (15%) 12 95 (69%) 28 (20%) 16 107 (78%) 26 (18%) 20 103 (79%) 27 (21%) In this study, patients were also evaluated for the effect of LATISSE ® solution on the length, thickness and darkness of their eyelashes. Improvements from baseline in eyelash growth as measured by digital image analysis assessing eyelash length, fullness/thickness, and darkness were statistically significantly more pronounced in the bimatoprost group at weeks 8, 12, and 16.

Table 3 Efficacy endpoint at Week 16 (Mean Change from Baseline) LATISSE ® Vehicle Eyelash growth (length) (mm; % increase) N=137 1.4; 25% N=141 0.1; 2% Fullness/thickness (mm 2 ; % increase) N=136 0.7; 106% N=140 0.1; 12% Eyelash darkness (intensity*; % increase in darkness) N=135 -20.2; -18% N=138 -3.6; -3% * a negative value is representative of eyelash darkening After the 16-week treatment period, a 4-week post-treatment period followed during which the effects of bimatoprost started to return toward baseline. The effect on eyelash growth is expected to abate following longer term discontinuation.

🧪 Nonclinical Toxicology 136 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Bimatoprost was not carcinogenic in either mice or rats when administered by oral gavage for 104 weeks at doses up to 2 mg/kg/day and 1 mg/kg/day, respectively (192 and 291 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily based on blood AUC levels). Mutagenesis Bimatoprost was not mutagenic or clastogenic in the Ames test, in the mouse lymphoma test, or in the in vivo mouse micronucleus tests.

Impairment of Fertility Bimatoprost did not impair fertility in male or female rats up to doses of 0.6 mg/kg/day (103 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily based on blood AUC levels).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 133 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Bimatoprost was not carcinogenic in either mice or rats when administered by oral gavage for 104 weeks at doses up to 2 mg/kg/day and 1 mg/kg/day, respectively (192 and 291 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily based on blood AUC levels). Mutagenesis Bimatoprost was not mutagenic or clastogenic in the Ames test, in the mouse lymphoma test, or in the in vivo mouse micronucleus tests.

Impairment of Fertility Bimatoprost did not impair fertility in male or female rats up to doses of 0.6 mg/kg/day (103 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily based on blood AUC levels).

📄 Patient Package Insert ~3 min read ▾

FDA-approved Patient Labeling PATIENT INFORMATION LATISSE ® [la teece] (bimatoprost ophthalmic solution) 0.03% Read the Patient Information that comes with LATISSE ® before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your physician about your treatment.

What is hypotrichosis of the eyelashes? Hypotrichosis is another name for having inadequate or not enough eyelashes. What is LATISSE ® solution?

LATISSE ® solution is a prescription treatment for hypotrichosis used to grow eyelashes, making them longer, thicker and darker. Who should NOT take LATISSE ® ? Do not use LATISSE ® solution if you are allergic to one of its ingredients.

Are there any special warnings associated with LATISSE ® use? LATISSE ® solution is intended for use on the skin of the upper eyelid margins at the base of the eyelashes . Refer to Illustration 2 below.

DO NOT APPLY to the lower eyelid. If you are using LUMIGAN ® or other products in the same class for elevated intraocular pressure (IOP), or if you have a history of abnormal IOP, you should only use LATISSE ® under the close supervision of your physician. LATISSE ® use may cause darkening of the eyelid skin which may be reversible.

LATISSE ® use may also cause increased brown pigmentation of the colored part of the eye which is likely to be permanent. It is possible for hair growth to occur in other areas of your skin that LATISSE ® frequently touches. Any excess solution outside the upper eyelid margin should be blotted with a tissue or other absorbent material to reduce the chance of this from happening.

It is also possible for a difference in eyelash length, thickness, fullness, pigmentation, number of eyelash hairs, and/or direction of eyelash growth to occur between eyes. These differences, should they occur, will usually go away if you stop using LATISSE ® . Who should I tell that I am using LATISSE ® ?

You should tell your physician you are using LATISSE ® especially if you have a history of eye pressure problems. You should also tell anyone conducting an eye pressure screening that you are using LATISSE ® . What should I do if I get LATISSE ® in my eye?

LATISSE ® solution is an ophthalmic drug product. LATISSE ® is not expected to cause harm if it gets into the eye proper. Do not attempt to rinse your eye in this situation.

What are the possible side effects of LATISSE ® ? The most common side effects after using LATISSE ® solution are an itching sensation in the eyes and/or eye redness. This was reported in approximately 4% of patients.

LATISSE ® solution may cause other less common side effects which typically occur on the skin close to where LATISSE ® is applied, or in the eyes. These include skin darkening, eye irritation, dryness of the eyes, and redness of the eyelids. If you develop a new ocular condition (e.g., trauma or infection), experience a sudden decrease in visual acuity, have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, you should immediately seek your physician’s advice concerning the continued use of LATISSE ® solution.

What happens if I stop using LATISSE ® ? If you stop using LATISSE ® , your eyelashes are expected to return to their previous appearance over several weeks to months. Any eyelid skin darkening is expected to reverse after several weeks to months.

Any darkening of the colored part of the eye known as the iris is NOT expected to reverse and is likely permanent. How do I use LATISSE ® ? The recommended dosage is one application nightly to the skin of the upper eyelid margin at the base of the eyelashes only.

Once nightly, start by ensuring your face is clean, makeup and contact lenses are removed. Remove an applicator from its tray. Then, holding the sterile applicator horizontally, place one drop of LATISSE ® on the area of the applicator closest to the tip but not on the tip (see Illustration 1).

Then immediately draw t… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 49 words ▾

PRINCIPAL DISPLAY PANEL NDC 0023-3616-70 Latisse ® (bimatoprost ophthalmic solution) 0.03% Rx only abbvie Contents: One 3 mL bottle of sterile solution 70 disposable applicators PRINCIPAL DISPLAY PANEL NDC 0023-3616-70 Latisse® (bimatoprost ophthalmic solution) 0.03% Rx only abbvie Contents: One 3 mL bottle of sterile solution 70 disposable applicators

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Lumigan (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Lumigan. CMS lists 3 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$135.7M
Claims incl. refills
274.2K
Beneficiaries
185.1K
Spend / beneficiary
$733.21
Spend / claim
$494.84
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for LATISSE (this brand).

Top reported reactions

Ocular Hyperaemia1,478
Madarosis1,367
Eye Irritation1,019
Eye Pruritus963
Erythema Of Eyelid900
Eyelids Pruritus482
Eye Swelling479

Age at onset

Neonate1
Infant1
Child2
Adolescent2
Adult129
Elderly251

Reporter sex

11,186 reports

Serious outcomes

Hospitalization706
Life-threatening121
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 698 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 00023-3615-01 · Allergan, 00023-3670-03 · Allergan, →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.