Tropicamide
Anticholinergics
Sold as MYDRIACYL
- Drug class
- Anticholinergics
- Availability
- Prescription only
- Routes
- Ophthalmic
- Markets covered
- 3
- Products on record
- 12
- FDA reports (12 mo)
- 93
Overview
Plain-language summary, compiled from the cited regulatory records
Tropicamide is an anticholinergic medication [1]. It is approved for use in mydriasis and cycloplegia, which are procedures involving pupil dilation and eye muscle paralysis, respectively [1]. These actions allow for better visualization during diagnostic eye examinations.
In the market, tropicamide is available under various brand names, including Mydriacyl [1]. Over the past 12 months, there have been 93 adverse event reports associated with this active ingredient [2]. The most frequently reported adverse events include ischaemic stroke, off-label use, eye pain, endophthalmitis, and reduced visual acuity [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 6 | May 22, 2026 |
| CA Canada | Health Canada | 4 | August 1, 2025 |
| US United States | FDA | 2 | February 15, 2023 |
GBUnited Kingdom· MHRA
6 products
Uses
As a topical mydriatic and cycloplegic.
How to take
CACanada· Health Canada
4 products
Uses
5% w/v and 1% w/v Benzalkonium chloride as preservative. For a complete listing see Dosage Forms, Composition and Packaging section. INDICATIONS AND CLINICAL USE MYDRIACYL® (tropicamide ophthalmic solution, USP) is a cycloplegic and mydriatic agent indicated for refraction.
Pediatrics:
Tropicamide may cause central nervous system disturbances, which may be dangerous in infants and children. MYDRIACYL should be used with extreme caution in infants, small or premature children, or children with Down syndrome, spastic paralysis or brain damage.
e. < 3 months of age). CONTRAINDICATIONS MYDRIACYL is contraindicated in: Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the Prescribing Information.
Patients with known or suspected narrow angle glaucoma. MYDRIACYL 1% should not be used in small infants. MYDRIACYL Prescribing Information Page 4 of 10 WARNINGS AND PRECAUTIONS Ophthalmologic MYDRIACYL may cause increased intraocular pressure (IOP).
USUnited States· FDA
2 products
Uses
INDICATIONS AND USAGE
For mydriasis and cycloplegia for diagnostic procedures.
How to take
Drug interactions
Known interactions involving Tropicamide. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL355330198 · revised March 27, 2026
- [2]Health Canada (DPD) · 00000981 · revised March 22, 2025
- [3]FDA DailyMed · 0104ffe4-013d-4a… · revised June 29, 2022 [PDF]
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.