Atropine Sulfate

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 (canonical bytes are SHA-256 checked before publication)

Brand name
Atropine Sulfate
Generic name
ATROPINE SULFATE
Manufacturer
Medical Purchasing Solutions, LLC
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
6bb51b79-ae86-aebf-e053-2991aa0a8d33
SPL ID
fd021c33-19cc-b7f5-e053-6394a90a9302
Version
4
Effective date
2023-05-31
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:23:47
Harmonized routes table
Harmonized routes
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Atropine is a highly potent drug and due care is essential to avoid overdosage, especially with intravenous administration. Pediatric populations are more susceptible than adults to the toxic effects of anticholinergic agents. Atropine I.V. decreased the rate of mexiletine absorption without altering the relative oral bioavailability; this delay in mexiletine absorption was reversed by the combination of atropine and intravenous metoclopramide during pretreatment for anesthesia. Atropine is not removed by dialysis. This drug is effective in very low dosage and overdose may cause permanent damage or death, especially in children. This product contains Benzyl Alcohol which has been associated with a fatal gasping syndrome in infants and neonates.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 2 matching rows.

adverse reactions

ADVERSE REACTIONS 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. 5 mg - Increase in the 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, disorentation, hallucinations, delirium and coma. 65 mg - May be fatal. A scarlatiniform rash may occur. Atropine may produce fever, particularly in children, through inhibition of heat loss by evaporation. Although large doses of atropine may cause an alarming condition, recovery is usual.

adverse reactions table

<table><colgroup><col/><col/></colgroup><tbody><tr><td> 0.5 mg -</td><td> Slight dryness of nose and mouth, bradycardia.</td></tr><tr><td> 1 mg -</td><td> Greater dryness of nose and mouth, with thirst; slowing, then acceleration of heart; slight mydriasis.</td></tr><tr><td> 2 mg -</td><td> Very dry mouth, tachycardia, with palpitation, mydriasis, slight blurring of near vision.</td></tr><tr><td> 5 mg -</td><td> Increase in the above symptoms plus disturbance of speech, difficulty in swallowing, headache, hot, dry skin, restlessness with asthenia.</td></tr><tr><td> 10 mg and over -</td><td> Above symptoms to extreme degree, plus ataxia, excitement, disorentation, hallucinations, delirium and coma.</td></tr><tr><td> 65 mg -</td><td> May be fatal.</td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.