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Bimatoprost

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Active ingredient
Bimatoprost 0.1 mg/1 mL
Other brand names
Drug class
Prostaglandin Analog
Dosage form
Solution/ Drops
Route
Ophthalmic
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2026
Label revision date
March 17, 2026
FDA Insert
Prescribing information, PDF file
Active ingredient
Bimatoprost 0.1 mg/1 mL
Other brand names
Drug class
Prostaglandin Analog
Dosage form
Solution/ Drops
Route
Ophthalmic
Prescription status
Rx (prescription)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2026
Label revision date
March 17, 2026
Manufacturer
Lifestar Pharma LLC
Registration number
ANDA218196
NDC roots
70756-626, 70756-627, 70756-628
FDA Insert
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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If you are a consumer or patient please visit this version.

Drug Overview

Bimatoprost ophthalmic solution 0.01% is a synthetic medication designed to help lower elevated intraocular pressure in individuals with open-angle glaucoma or ocular hypertension (high pressure in the eye). It works by mimicking a natural substance in the body that helps regulate fluid in the eye, thereby reducing pressure and helping to protect your vision.

This solution is a clear, sterile liquid that is easy to apply to the eyes. It contains bimatoprost as its active ingredient, which is effective in managing eye pressure. If you have concerns about your eye health or pressure, this medication may be an option to discuss with your healthcare provider.

Uses

Bimatoprost ophthalmic solution 0.01% is used to help lower high eye pressure in people who have open-angle glaucoma or ocular hypertension. Elevated intraocular pressure can lead to serious eye problems, so this medication is important for managing your eye health.

If you have been prescribed this solution, it’s designed to help protect your vision by keeping your eye pressure within a normal range. Always follow your healthcare provider's instructions on how to use it effectively.

Dosage and Administration

To use this medication, you will need to apply one drop directly into the affected eye or eyes. It's important to do this once daily, and the best time to apply it is in the evening. This routine helps ensure that the medication works effectively to address your condition. Remember to follow this schedule consistently for the best results.

What to Avoid

It’s important to be aware of certain situations where you should not take this medication. If you have a hypersensitivity (an extreme allergic reaction) to any component of the drug, you should avoid using it altogether.

Additionally, this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. Be cautious and follow your healthcare provider's instructions closely to prevent any issues related to dependence (a condition where your body becomes reliant on a substance). Always prioritize your safety and consult with your doctor if you have any concerns.

Side Effects

You may experience some common side effects while using this medication. The most frequently reported reaction is conjunctival hyperemia, which is redness of the eye, occurring in about 31% of users. Additionally, you might notice changes in your eyelashes, such as increased length, thickness, and number, which are usually reversible.

There is also a possibility of pigmentation changes, which can affect the iris (the colored part of your eye), the skin around your eyes (periorbital tissue), and your eyelashes. It's important to note that any changes to the iris pigmentation are likely to be permanent. Lastly, some individuals may experience hypersensitivity, which is an allergic reaction. If you notice any unusual symptoms, please consult your healthcare provider.

Warnings and Precautions

You should be aware that using this medication may lead to changes in pigmentation, particularly in the iris (the colored part of your eye), eyelids, and eyelashes. The change in iris pigmentation is likely to be permanent, so it's important to consider this before starting treatment.

Additionally, you may notice gradual changes to your eyelashes, such as increased length, thickness, and number of lashes. These changes are usually reversible, but it's good to keep an eye on them. If you experience any unexpected side effects or have concerns, please stop using the medication and contact your doctor for guidance.

Overdose

If you suspect an overdose of bimatoprost ophthalmic solution 0.01%, it's important to know that there is no specific information available about overdosing in humans. In animal studies, even very high doses did not show toxicity, but this does not guarantee safety in humans. If an overdose occurs, treatment should focus on relieving symptoms.

You should be aware of any unusual signs or symptoms that may arise and seek medical attention if you notice anything concerning. Always consult a healthcare professional if you have questions or if you believe an overdose has happened. It's better to be cautious and get help when needed.

Pregnancy Use

There are currently no well-controlled studies on the use of bimatoprost ophthalmic solution 0.01% in pregnant women. While postmarketing data suggest no increased risk of major birth defects or miscarriages, animal studies have shown that high doses can lead to abortion and early delivery in pregnant mice and rats. These adverse effects were not seen at lower doses, indicating that the risk may depend on the amount used.

If you are pregnant or planning to become pregnant, it is important to discuss the use of bimatoprost with your healthcare provider. The potential benefits of using this medication should be carefully weighed against the possible risks to your fetus. Always consult your doctor before starting or continuing any medication during pregnancy.

Lactation Use

If you are breastfeeding and considering the use of bimatoprost ophthalmic solution 0.01%, it's important to know that it is unclear whether this eye treatment can enter your breast milk in significant amounts. While studies in lactating rats have shown that bimatoprost can be found in breast milk at much higher doses than what is typically used in humans, there is no specific data on its presence in human milk at normal doses.

When making your decision, weigh the benefits of breastfeeding against your need for this medication and any potential risks to your nursing child. Always consult with your healthcare provider to discuss your options and ensure the best outcome for both you and your baby.

Pediatric Use

It is important to be cautious when considering this medication for children. The use of this drug in patients under 16 years old is not recommended due to potential safety concerns. Specifically, there is a risk of increased pigmentation (darkening of the skin) that may occur with long-term use.

If you are a parent or caregiver, it's best to consult with a healthcare professional to discuss safe treatment options for your child. Always prioritize their health and well-being when making decisions about medications.

Geriatric Use

As an older adult or caregiver, it's reassuring to know that there are no significant differences in safety or effectiveness when using this medication compared to younger adults. This means that you can expect similar results and side effects as other adults, which can help you feel more confident in your treatment plan.

However, it's always important to discuss any specific health concerns or conditions with your healthcare provider, as individual needs may vary. Your doctor can help ensure that the medication is appropriate for you and monitor any potential side effects.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the provided information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any lab tests you undergo, as this helps in managing your health effectively.

Storage and Handling

To ensure the best results with your bimatoprost ophthalmic solution 0.01%, store it in a cool, dry place at a temperature between 2°C to 25°C (36°F to 77°F). This helps maintain the effectiveness of the solution. Once you open the bottle, you can continue to use it safely until the expiration date printed on the label.

Always handle the bottle with clean hands to avoid contamination, and make sure to keep the dropper tip away from any surfaces to maintain its sterility (the condition of being free from bacteria or other living microorganisms). Following these guidelines will help you use the product safely and effectively.

Additional Information

You should be aware that treatment with this medication may lead to increased pigmentation, particularly in the iris (the colored part of your eye). If you notice any significant changes in your eye color, it's important to have regular check-ups with your healthcare provider.

Additionally, if you wear contact lenses, make sure to remove them before using the bimatoprost ophthalmic solution 0.01%. You can put your lenses back in about 15 minutes after applying the solution.

FAQ

What is Bimatoprost ophthalmic solution 0.01%?

Bimatoprost ophthalmic solution 0.01% is a synthetic prostamide analog used to reduce elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.

How should I use Bimatoprost ophthalmic solution 0.01%?

You should instill one drop in the affected eye(s) once daily in the evening.

What are the common side effects of Bimatoprost?

The most common side effect is conjunctival hyperemia, which occurs in about 31% of patients.

Can Bimatoprost cause changes in eye pigmentation?

Yes, Bimatoprost can cause pigmentation of the iris, periorbital tissue, and eyelashes, with iris pigmentation likely being permanent.

Are there any precautions for using Bimatoprost?

You should be aware of potential eyelash changes, including increased length and thickness, which are usually reversible.

Is Bimatoprost safe to use during pregnancy?

Bimatoprost should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus, as animal studies have shown adverse effects.

Can I use Bimatoprost if I am breastfeeding?

It is not known if Bimatoprost is excreted in human milk, so you should consider the benefits of breastfeeding alongside the mother's need for the medication.

What should I do if I experience increased pigmentation?

If you notice increased iris pigmentation, you should be examined regularly by your doctor.

What should I do before using Bimatoprost if I wear contact lenses?

You should remove your contact lenses prior to instilling Bimatoprost and may reinsert them 15 minutes after administration.

What are the storage conditions for Bimatoprost?

Store Bimatoprost at 2°C to 25°C (36°F to 77°F) and use it until the expiration date on the bottle after opening.

Packaging Info

The table below lists all NDC Code configurations of Bimatoprost, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Bimatoprost.
Details

FDA Insert (PDF)

This is the full prescribing document for Bimatoprost, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.

View FDA-approved insert (PDF)

Description

Bimatoprost ophthalmic solution 0.01% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-(1E,3S)-3-hydroxy-5-phenyl-1-pentenylcyclopentyl]-N-ethyl-5-heptenamide. The molecular weight of bimatoprost is 415.6 g/mol, and its molecular formula is C25H37NO4. Bimatoprost appears as a white or almost white crystalline powder and is very soluble in ethyl alcohol and methyl alcohol, while being slightly soluble in water.

Bimatoprost ophthalmic solution 0.01% is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. The solution contains active bimatoprost at a concentration of 0.1 mg/mL and includes the preservative benzalkonium chloride at 0.2 mg/mL. Inactive ingredients consist of boric acid, glycerin, sodium borate, and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust the pH, which ranges from 6.8 to 7.8 during its shelf life.

Uses and Indications

Bimatoprost ophthalmic solution 0.01% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.

There are no teratogenic or nonteratogenic effects associated with this medication.

Dosage and Administration

The recommended dosage for administration is one drop in the affected eye(s) once daily in the evening. Healthcare professionals should instruct patients to ensure proper technique when administering the drop to maximize efficacy and minimize potential contamination. It is advised that patients tilt their head back, pull down the lower eyelid to create a pocket, and instill the drop without touching the eye or eyelid with the dropper tip. After administration, patients should close their eyes gently and may apply pressure to the inner corner of the eye to prevent systemic absorption.

Contraindications

Use of this product is contraindicated in individuals with a known hypersensitivity to any component of the formulation. Due to the potential for severe allergic reactions, administration in such cases may pose significant health risks.

Warnings and Precautions

Pigmentation of the iris, periorbital tissue (eyelid), and eyelashes may occur with the use of this medication. It is important to note that iris pigmentation is likely to be permanent. Healthcare professionals should inform patients about this potential side effect to ensure they are adequately prepared for any changes.

In addition to pigmentation changes, patients may experience gradual alterations in their eyelashes, including increased length, thickness, and number of lashes. These changes are typically reversible upon discontinuation of the medication. Monitoring for these effects is advisable, and healthcare providers should counsel patients on what to expect during treatment.

Currently, there are no specific laboratory tests or emergency medical help instructions associated with the use of this medication. However, healthcare professionals should remain vigilant and encourage patients to report any unusual symptoms or concerns that may arise during their treatment.

Side Effects

In clinical trials, the most common adverse reaction observed was conjunctival hyperemia, reported in 31% of patients. Additionally, pigmentation changes may occur, affecting the iris, periorbital tissue (eyelid), and eyelashes. Notably, iris pigmentation is likely to be permanent.

Patients may also experience changes in their eyelashes, characterized by a gradual increase in length, thickness, and number of lashes; these changes are usually reversible. Furthermore, hypersensitivity reactions have been noted among participants.

These adverse reactions should be carefully monitored in patients receiving treatment.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

The table below lists all NDC Code configurations of Bimatoprost, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Bimatoprost.
Details

Pediatric Use

Use in pediatric patients below the age of 16 years is not recommended due to potential safety concerns. Specifically, there is an increased risk of pigmentation changes associated with long-term chronic use in this population. Healthcare professionals should exercise caution when considering treatment options for children and adolescents under 16 years of age.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, have not demonstrated any overall clinical differences in safety or effectiveness compared to younger adult patients. Therefore, no specific dosage adjustments are necessary for this population.

However, healthcare providers should remain vigilant in monitoring geriatric patients for any potential age-related changes that may influence drug metabolism and response. It is essential to consider individual patient factors, including comorbidities and concurrent medications, when prescribing to elderly patients to ensure optimal therapeutic outcomes.

Pregnancy

There are no adequate and well-controlled studies of bimatoprost ophthalmic solution 0.01% in pregnant women. Postmarketing experience has not indicated an increase in the risk of major birth defects or miscarriages associated with bimatoprost. However, animal studies have demonstrated potential risks. In embryofetal developmental studies, administration of bimatoprost to pregnant mice and rats during organogenesis resulted in abortion and early delivery at oral doses significantly higher than human exposure levels. Specifically, these adverse effects were observed at doses at least 33 times (mice) or 94 times (rats) the human exposure to bimatoprost 0.03% dosed bilaterally once daily, based on blood area under the curve (AUC) levels.

Conversely, no adverse effects were noted at lower doses, specifically at 2.6 times (mice) and 47 times (rats) the human exposure. In pre/postnatal development studies, administration of bimatoprost to pregnant rats from organogenesis through lactation resulted in reduced gestation length, increased fetal and pup mortality, and decreased fetal body weight at doses at least 41 times the human systemic exposure. No adverse effects were observed in rat offspring at exposures estimated at 14 times the human exposure.

Due to the potential risks identified in animal studies, bimatoprost ophthalmic solution 0.01% should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. The No Observed Adverse Effect Level (NOAEL) for abortion in rats was determined to be 0.3 mg/kg/day (47 times the human exposure), while in mice, the NOAEL for abortion and early delivery was 0.1 mg/kg/day (2.6 times the human exposure). No abnormalities were observed in fetuses at doses up to 0.6 mg/kg/day in both species. Given that animal reproductive studies may not always predict human response, careful consideration is warranted when prescribing this medication to pregnant patients.

Lactation

It is not known whether topical ocular treatment with bimatoprost ophthalmic solution 0.01% could result in sufficient systemic absorption to produce detectable quantities in human milk. In animal studies, bimatoprost has been shown to be present in the breast milk of lactating rats at an intravenous dose (1 mg/kg) 970 times the recommended human oral dose (RHOD) on a mg/m² basis; however, no animal data is available at clinically relevant doses.

The developmental and health benefits of breastfeeding should be considered alongside the mother's clinical need for bimatoprost ophthalmic solution 0.01% and any potential adverse effects on the breastfed child from this treatment.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when treating patients with renal impairment.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data may necessitate careful monitoring and assessment of liver function.

Overdosage

In the event of an overdose with bimatoprost ophthalmic solution 0.01%, there is currently no available information regarding overdosage in humans. Should an overdose occur, the recommended course of action is to provide symptomatic treatment as necessary.

Toxicological studies conducted in mice and rats via oral administration (by gavage) have demonstrated that doses up to 100 mg/kg/day did not result in any observable toxicity. This dosage is significantly higher—at least 210 times—than the potential accidental ingestion of an entire bottle of bimatoprost ophthalmic solution 0.01% by a child weighing 10 kg.

Healthcare professionals should remain vigilant for any symptoms that may arise from an overdose and manage them accordingly, although specific symptoms related to bimatoprost overdose have not been documented.

Nonclinical Toxicology

Bimatoprost was evaluated for its carcinogenic potential in both mice and rats. In these studies, it was administered via oral gavage for a duration of 104 weeks at doses of up to 2 mg/kg/day for mice and 1 mg/kg/day for rats. The results indicated that bimatoprost was not carcinogenic, with the doses corresponding to 192 and 291 times the estimated human systemic exposure to bimatoprost 0.03% when dosed bilaterally once daily, based on blood AUC levels.

In terms of mutagenicity, bimatoprost demonstrated no mutagenic or clastogenic effects in several assays, including the Ames test, the mouse lymphoma test, and in vivo mouse micronucleus tests.

Furthermore, bimatoprost did not impair fertility in male or female rats at doses up to 0.6 mg/kg/day. This dose represents at least 103 times the recommended human exposure to bimatoprost 0.03% dosed bilaterally once daily, based on blood AUC levels.

Postmarketing Experience

Postmarketing experience has identified several events reported voluntarily or through surveillance programs. There is a potential for increased brown pigmentation of the iris, which may be permanent. Additionally, there is a possibility of eyelid skin darkening, which may be reversible following the discontinuation of bimatoprost ophthalmic solution 0.01%.

Changes in eyelashes and vellus hair in the treated eye have also been observed during treatment with bimatoprost ophthalmic solution 0.01%. These changes may lead to disparities between eyes in terms of length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. It is noted that eyelash changes are generally reversible upon discontinuation of treatment.

Patient Counseling

Healthcare providers should advise patients about the potential for increased brown pigmentation of the iris, which may be permanent. Patients should also be informed about the possibility of eyelid skin darkening, which may be reversible after discontinuation of bimatoprost ophthalmic solution 0.01%.

It is important to inform patients of the possibility of changes in eyelashes and vellus hair in the treated eye during treatment with bimatoprost ophthalmic solution 0.01%. These changes may lead to differences between eyes in terms of length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Patients should be reassured that eyelash changes are usually reversible upon discontinuation of treatment.

Healthcare providers should instruct patients to avoid allowing the tip of the dispensing container to come into contact with the eye, surrounding structures, fingers, or any other surface. This precaution is essential to prevent contamination of the solution by common bacteria that can cause ocular infections, which may lead to serious damage to the eye and potential loss of vision.

Patients should be advised to seek immediate medical advice if they develop an intercurrent ocular condition, such as trauma or infection, undergo ocular surgery, or experience any ocular reactions, particularly conjunctivitis and eyelid reactions, regarding the continued use of bimatoprost ophthalmic solution 0.01%.

Additionally, healthcare providers should inform patients that bimatoprost ophthalmic solution 0.01% contains benzalkonium chloride, which may be absorbed by soft contact lenses. Patients should be instructed to remove their contact lenses prior to instillation of the solution and may reinsert them 15 minutes after administration.

Finally, if patients are using more than one topical ophthalmic drug, they should be advised to administer the drugs at least five (5) minutes apart to ensure proper absorption and effectiveness.

Storage and Handling

Bimatoprost ophthalmic solution 0.01% is supplied in a container that allows for easy dispensing. It should be stored at a temperature range of 2°C to 25°C (36°F to 77°F) to maintain its efficacy.

Once opened, the solution can be used until the expiration date indicated on the bottle. It is important to ensure that the container is properly sealed when not in use to prevent contamination and preserve the integrity of the product.

Additional Clinical Information

Patients receiving treatment with bimatoprost ophthalmic solution 0.01% should be informed about the potential for increased pigmentation, particularly in the iris. Regular examinations are recommended for patients who notice significant changes in iris pigmentation. Additionally, it is advised that contact lenses be removed before the administration of the solution and can be reinserted 15 minutes after application.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Bimatoprost as submitted by Lifestar Pharma LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Bimatoprost, retrieved by a validated AI data-extraction workflow.

All FDA-approved dosage forms and strengths are listed in the Packaging & NDC Codes section above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book (ANDA218196) and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.