Bepotastine Besilate: uses, dosing, side effects & brands
Bepotastine Besilate is a histamine-1 receptor antagonist sold in the U.S. under one brand, for allergic conjunctivitis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Histamine-1 Receptor Antagonist
- Treats
- Allergic Conjunctivitis
- Available as
- Drops
- Sold as
- Bepreve
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How bepotastine besilate is dosed
From the FDA label for Bepreve (application NDA022288). Other bepotastine besilate products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Instill one drop of BEPREVE into the affected eye(s) twice a day. Remove contact lenses prior to instillation of BEPREVE. • Instill one drop into the affected eye(s) twice a day. ( 2 ) • Remove contact lenses prior to instillation of BEPREVE. ( 2 )
Bepotastine Besilate side effects
The most common adverse reaction occurring in approximately 25% of patients was a mild taste following instillation. Other adverse reactions which occurred in 2-5% of subjects were eye irritation, headache, and nasopharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 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 clinical practice. The most common reported adverse reaction occurring in approximately 25% of subjects was a mild taste following instillation. Other adverse reactions occurring in 2-5% of subjects were eye irritation, headache, and nasopharyngitis. 6.2 Post-Marketing Experience Hypersensitivity reactions have been reported rarely during the post-marketing use of BEPREVE. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The hypersensitivity reactions may include itching, body rash, and swelling of lips, tongue and/or throat. 6.1 Clinical Trials Experience Because clinical…
Who shouldn’t take bepotastine besilate
BEPREVE is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients [see Adverse Reactions ( 6.2 )] . Hypersensitivity to any component of this product. ( 4 )
Every bepotastine besilate product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Bepreve.
What people report to the FDA about bepotastine besilate
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 335 reports naming bepotastine besilate, and the FDA flagged 86% 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:
- hepatic function abnormal22 reports
- diarrhoea18 reports
- pyrexia18 reports
- pneumonia15 reports
- pruritus13 reports
- decreased appetite12 reports
- erythema multiforme12 reports
- nausea12 reports
Read these as a signal, not a rate. A report does not mean bepotastine besilate 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 section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is bepotastine besilate?
Bepreve (Bepotastine Besilate) is a histamine-1 receptor antagonist used to treat Allergic Conjunctivitis.
What kind of drug is bepotastine besilate?
The FDA classifies bepotastine besilate as a histamine-1 receptor antagonist. H1 antihistamines work by blocking histamine, the chemical released during an allergic reaction, from attaching to H1 receptors. This prevents the sneezing, itching, runny nose, watery eyes, and hives that histamine would otherwise trigger. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take bepotastine besilate with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run bepotastine besilate against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does bepotastine besilate come in?
Across the brands we track, bepotastine besilate is currently marketed as drops, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic bepotastine besilate?
We do not currently list a generic-labelled bepotastine besilate product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Bepotastine Besilate: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/bepotastine-besilate
- MLA
- “Bepotastine Besilate: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/bepotastine-besilate.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for bepotastine besilate on DailyMed (NIH) ↗.