EPINASTINE: 843 Adverse Event Reports & Safety Profile
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Active Ingredient: EPINASTINE HYDROCHLORIDE · Drug Class: Adrenergic Agonists [MoA] · Route: OPHTHALMIC · Manufacturer: Somerset Therapeutics, LLC · FDA Application: 021565 · HUMAN PRESCRIPTION DRUG · FDA Label: Available
First Report: 20100505 · Latest Report: 20240901
What Are the Most Common EPINASTINE Side Effects?
All EPINASTINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Treatment failure | 660 | 78.3% | 0 | 0 |
| Drug ineffective | 90 | 10.7% | 0 | 1 |
| Alopecia areata | 12 | 1.4% | 0 | 0 |
| Hypersensitivity | 10 | 1.2% | 0 | 0 |
| Eye irritation | 8 | 1.0% | 0 | 0 |
| Off label use | 8 | 1.0% | 0 | 0 |
| Anaemia | 6 | 0.7% | 0 | 0 |
| Erythema | 6 | 0.7% | 0 | 2 |
| Eye pain | 6 | 0.7% | 0 | 0 |
| Pruritus | 6 | 0.7% | 0 | 1 |
| Alopecia totalis | 5 | 0.6% | 0 | 0 |
| Blood pressure decreased | 5 | 0.6% | 0 | 1 |
| Contraindicated product administered | 5 | 0.6% | 0 | 0 |
| Decreased appetite | 5 | 0.6% | 1 | 0 |
| Dizziness postural | 5 | 0.6% | 0 | 0 |
| Dyspnoea | 5 | 0.6% | 0 | 2 |
| Face oedema | 5 | 0.6% | 0 | 0 |
| Intentional product misuse | 5 | 0.6% | 0 | 0 |
| Malaise | 5 | 0.6% | 1 | 1 |
Who Reports EPINASTINE Side Effects? Age & Gender Data
Gender: 66.9% female, 33.1% male. Average age: 50.0 years. Most reports from: COUNTRY NOT SPECIFIED. View detailed demographics →
Is EPINASTINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2010 | 2 | 1 | 2 |
| 2011 | 4 | 0 | 4 |
| 2013 | 2 | 0 | 0 |
| 2014 | 10 | 2 | 2 |
| 2015 | 3 | 0 | 0 |
| 2016 | 4 | 0 | 2 |
| 2017 | 13 | 1 | 1 |
| 2018 | 4 | 0 | 2 |
| 2019 | 5 | 0 | 2 |
| 2020 | 4 | 1 | 1 |
| 2021 | 4 | 0 | 1 |
| 2022 | 11 | 0 | 2 |
| 2023 | 3 | 0 | 2 |
| 2024 | 1 | 0 | 0 |
What Is EPINASTINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 760 |
| Pruritus | 9 |
| Asthma | 6 |
| Hypersensitivity | 6 |
| Rhinitis allergic | 6 |
EPINASTINE vs Alternatives: Which Is Safer?
Official FDA Label for EPINASTINE
Official prescribing information from the FDA-approved drug label.
Drug Description
Epinastine HCl Ophthalmic Solution 0.05% is a clear, colorless, sterile isotonic solution containing epinastine HCl, an antihistamine and an inhibitor of histamine release from the mast cell for topical administration to the eyes. Epinastine HCl is represented by the following structural formula: C 16 H 15 N 3 HCl Mol. Wt.
285.78 Chemical Name: 3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo [1,5-a]azepine hydrochloride Each mL contains: Active: epinastine HCl 0.05% (0.5 mg/mL) equivalent to epinastine 0.044% (0.44 mg/mL); Preservative: benzalkonium chloride 0.01%; Inactives: edetate disodium; water for injection; sodium chloride; sodium phosphate, monobasic; and sodium hydroxide and/or hydrochloric acid (to adjust pH). Epinastine HCl has a pH of approximately 7 and an osmolality range of 250 to 310 mOsm/kg.
Molecular
Structure
FDA Approved Uses (Indications)
AND USAGE Epinastine HCl ophthalmic solution is an H 1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis. Epinastine HCl ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis.
Dosage & Administration
AND ADMINISTRATION The recommended dosage is one drop in each eye twice a day. The recommended dosage is one drop in each eye twice a day. Treatment should be continued throughout the period of exposure (i.e., until the pollen season is over or until exposure to the offending allergen is terminated), even when symptoms are absent.
Contraindications
None None
Known Adverse Reactions
REACTIONS The most common ocular adverse reactions (incidence occurring in approximately 1% to 10% of epinastine HCl-treated eyes were burning sensation in the eye, folliculosis, hyperemia, and pruritus. The most common non-ocular adverse reactions, occurring in 10% epinastine HCl-treated eyes, were infection (cold symptoms and upper respiratory infections). To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at +1 800-417-9175 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The most frequently reported ocular adverse reactions occurring in approximately 1 to 10% of patients were burning sensation in the eye, folliculosis, hyperemia, and pruritus. The most frequently reported non-ocular adverse reactions were infection (cold symptoms and upper respiratory infections), seen in approximately 10% of patients, and headache, rhinitis, sinusitis, increased cough, and pharyngitis, seen in approximately 1 to 3% of patients. Some of these reactions were similar to the underlying disease being studied.
6.2 Postmarketing Experience The following reactions have been identified during postmarketing use of epinastine HCl in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to epinastine HCl, or a combination of these factors, include: lacrimation increased.
Warnings
AND PRECAUTIONS To minimize the risk of contamination, do not touch dropper tip to any surface. Keep bottle tightly closed when not in use. ( 5.1 ) Epinastine HCl should not be used to treat contact lens-related irritation. ( 5.2 ) Remove contact lenses prior to instillation of epinastine HCl.( 5.2 )