boxed warning
Pilocarpine HCl Ophthalmic Solution USP, 1% 15 mL - NDC 21695-368-01
FDA label d2ded29a-448d-4c4a-9307-403836a67da4
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- SPL set ID
- d2ded29a-448d-4c4a-9307-403836a67da4
- SPL ID
- d2ded29a-448d-4c4a-9307-403836a67da4
- Version
- 1
- Effective date
- 2011-03-15
- Source export date
- 2026-09-28
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:29:40
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | d2ded29a-448d-4c4a-9307-403836a67da4 | id | |
| spl set id | d2ded29a-448d-4c4a-9307-403836a67da4 | set_id |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
WARNINGS: Not for internal use. To prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: OCULAR: Transient symptoms of stinging and burning may occur. Ciliary spasm, conjunctival vascular congestion, temporal or supraorbital headache, lacrimation and induced myopia may occur. This is especially true in younger individuals who have recently started administration. Reduced visual acuity in poor illumination is frequently experienced by older individuals and individuals with lens opacity. Miotic agents may also cause retinal detachment; thus, care should be exercised with all miotic therapy especially in young myopic patients. Lens opacity may occur with prolonged use of pilocarpine. SYSTEMIC: Systemic reactions following topical administration, although extremely rare, have included hypertension, tachycardia, bronchiolar spasm, pulmonary edema, salivation, sweating, nausea, vomiting, and diarrhea.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.