Tropicamide
Solution/ Drops · Ophthalmic
Uses
For mydriasis and cycloplegia for diagnostic procedures.
Dosage and administration
For refraction, instill one or two drops of 1% solution in the eye(s), repeated in five minutes. If patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong mydriatic effect. Individuals with heavily pigmented irides may require higher strength or more doses. Mydriasis will reverse spontaneously with time, typically in 4 to 8 hours. However, in some cases, complete recovery may take up to 24 hours.
Contraindications
Contraindicated in persons showing hypersensitivity to any component of this preparation.
Warnings
WARNINGS FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. This preparation may cause CNS disturbances which may be dangerous in pediatric patients. The possibility of psychotic reactions and behavioral disturbances due to hypersensitivity to anticholinergic drugs should be considered. Mydriatics may produce a transient elevation of intraocular pressure. Remove contact lenses before using.
Precautions
General The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption. Information for Patients Do not touch dropper tip to any surface, as this may contaminate the solution. Patient should be advised not to drive or engage in potentially hazardous activities while pupils are dilated. Patient may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration. Drug Interactions Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors. Carcinogenesis, Mutagenesis, Impairment of Fertility There have been no long-term studies done using tropicamide in animals to evaluate carcinogenic potential. Pregnancy Animal reproduction studies have not been conducted with tropicamide. It is also not known whether tropicamide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tropicamide should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when tropicamide is administered to a nursing woman. Pediatric Use Tropicamide may rarely cause CNS disturbances which may be dangerous in pediatric patients. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs (See WARNINGS ). Keep this and all medications out of the reach of children. Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Side effects
Ocular: Transient stinging, blurred vision, photophobia and superficial punctuate keratitis have been reported with the use of tropicamide. Increased intraocular pressure has been reported following the use of mydriatics. Non-Ocular: Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs.
Drug interactions
Drug Interactions Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
Pregnancy
Pregnancy Animal reproduction studies have not been conducted with tropicamide. It is also not known whether tropicamide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tropicamide should be given to a pregnant woman only if clearly needed.
Pediatric use
Pediatric Use Tropicamide may rarely cause CNS disturbances which may be dangerous in pediatric patients. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs (See WARNINGS ). Keep this and all medications out of the reach of children.
Geriatric use
Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Description
Tropicamide Ophthalmic Solution, USP is an anticholinergic prepared as a sterile topical ophthalmic solution. The active ingredient is represented by the chemical structure: Established name: Tropicamide ophthalmic solution, USP Chemical name: Benzeneacetamide, N -ethyl-α-(hydroxymethyl)- N -(4-pyridinylmethyl). Each mL contains: Active: tropicamide 1%. Preservative: benzalkonium chloride 0.01%. Inactives: sodium chloride, edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH), Water for injection. pH range 4.0 - 5.8. Image
How supplied
Tropicamide Ophthalmic Solution USP, 1% (15 mL) filled in 15 mL Natural LDPE Bottle and natural LDPE nozzles with red colored HDPE caps. NDC 70069- 121 -01 STORAGE: Store at 8°C to 27°C (46°F-80°F). Do not refrigerate or store at high temperatures. Avoid freezing. Keep container tightly closed. Rx only For Product Inquiry call 1-800-417-9175. Revised: November, 2025 Manufactured for: Somerset Therapeutics, LLC Somerset, NJ 08873 Customer Care # 1-800-417-9175 Made in India Code No.: KR/DRUGS/KTK/28/289/97 ST-TRP21/P/02 1201367
Patient information
Information for Patients Do not touch dropper tip to any surface, as this may contaminate the solution. Patient should be advised not to drive or engage in potentially hazardous activities while pupils are dilated. Patient may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration.
Label text from the FDA structured product label by Somerset Therapeutics, LLC (revised Apr 10, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Tropicamide in 8 products
Tropicamide NDC products (8)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 24208-585 | Tropicamide 10 mg/mL Solution/ Drops | Bausch & Lomb Incorporated | ANDA |
| 24208-590 | Tropicamide 5 mg/mL Solution/ Drops | Bausch & Lomb Incorporated | ANDA |
| 61314-354 | Tropicamide 5 mg/mL Solution/ Drops | Sandoz Inc | ANDA |
| 61314-355 | Tropicamide 10 mg/mL Solution/ Drops | Sandoz Inc | ANDA |
| 70069-121 | Tropicamide 10 mg/mL Solution/ Drops | Somerset Therapeutics, LLC | ANDA |
| 85766-040 | Tropicamide 10 mg/mL Solution/ Drops | Sportpharm LLC | ANDA |
| 85766-278 | Tropicamide 10 mg/mL Solution/ Drops | Sportpharm LLC | ANDA |
| 85766-279 | Tropicamide 5 mg/mL Solution/ Drops | Sportpharm LLC | ANDA |
Tropicamide recalls
- D-0646-2016 Feb 3, 2016 · Class III · Terminated
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert. - D-0647-2016 Feb 3, 2016 · Class III · Terminated
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Frequently asked questions
What is Tropicamide used for?
For mydriasis and cycloplegia for diagnostic procedures.
What are the side effects of Tropicamide?
Ocular: Transient stinging, blurred vision, photophobia and superficial punctuate keratitis have been reported with the use of tropicamide. Increased intraocular pressure has been reported following the use of mydriatics. Non-Ocular: Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported… See the full label for the complete list.
Who makes Tropicamide?
Tropicamide is listed by 4 labelers in the FDA NDC directory, including Bausch & Lomb Incorporated, Sandoz Inc, Somerset Therapeutics, LLC, Sportpharm LLC.
Has Tropicamide been recalled?
The FDA enforcement database lists 2 recalls for Tropicamide, most recently D-0646-2016 (class iii): Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.