warnings
WARNING This drug is effective in very low dosage and overdose may cause permanent damage or death, especially in children.
FDA label 98bcd075-4fb0-4764-b1b2-91cb65c36b8a
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
- de6eabbd-0083-4647-8a10-fc50cf61b5d4
- SPL ID
- 98bcd075-4fb0-4764-b1b2-91cb65c36b8a
- Version
- 2
- Effective date
- 2022-12-30
- 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 05:28:13
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 | 98bcd075-4fb0-4764-b1b2-91cb65c36b8a | id | |
| spl set id | de6eabbd-0083-4647-8a10-fc50cf61b5d4 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Toxic effects from overdosage of atropine are not uncommon, especially in children. Individual tolerance varies greatly, but these systemic doses are likely to produce the following effects: 0.5 mg • Slight dryness of nose and mouth; bradycardia. 1 mg • Greater dryness of nose and mouth, with thirst; slowing then acceleration of heart; slight mydriasis. 2 mg • Very dry mouth; tachycardia with palpitation, mydriasis, slight blurring of near vision; flushed, dry skin. 5 mg • Increase in above symptoms plus disturbance of speech; difficulty in swallowing; headache, hot, dry skin; restlessness, with asthenia. 10 mg and over • Above symptoms to extreme degree, plus ataxia, excitement, disorientation, hallucinations, delirium, and coma. 65 mg • May be fatal. A scarlatiniform rash may occur. Atropine may reduce fever, particularly in children, through inhibition of heat loss by evaporation. Although large doses of atropine may cause an alarming condition, recovery is usual. In the treatment of atropine poisoning, respiratory assistance and symptomatic support are indicated. Pilocarpine is sometimes given but is of limited value.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.