FDA label 0acaa346-053f-417a-9ac5-9049fd62b650

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)

SPL set ID
da49e6de-5ff9-4682-bdb8-c06827219a56
SPL ID
0acaa346-053f-417a-9ac5-9049fd62b650
Version
3
Effective date
2016-11-30
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:04:14

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Neostigmine Methylsulfate Injection should be used with caution in patients with epilepsy, bronchial asthma, bradycardia, recent coronary occlusion, vagotonia, hyperthyroidism, cardiac arrhythmias or peptic ulcer. When large doses of Neostigmine Methylsulfate Injection are administered, the prior or simultaneous injection of atropine sulfate may be advisable. Separate syringes should be used for the neostigmine methylsulfate and atropine. Because of the possibility of hypersensitivity in an occasional patient, atropine and antishock medication should always be readily available.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 3 · 10 matching rows.

adverse reactions

ADVERSE REACTIONS Side effects are generally due to an exaggeration of pharmacological effects of which salivation and fasciculation are the most common. Bowel cramps and diarrhea may also occur. The following additional adverse reactions have been reported following the use of either neostigmine bromide or neostigmine methysulfate. Allergic Allergic reactions and anaphylaxis. Neurologic Dizziness, convulsions, loss of consciousness, drowsiness, headache, dysarthria, miosis and visual changes. Cardiovascular Cardiac arrhythmias (including bradycardia, tachycardia, atrioventricular block and nodal rhythm) and nonspecific electrocardiogram changes have been reported, as well as cardiac arrest, syncope and hypotension. These have been predominantly noted following the use of the injectable form of neostigmine methylsulfate. Respiratory Increased oral, pharyngeal and bronchial secretions, dyspnea, respiratory depression, respiratory arrest and bronchospasm. Dermatologic Rash and urticaria. Gastrointestinal Nausea, emesis, flatulence and increased peristalsis. Genitourinary Urinary frequency. Musculoskeletal Muscle cramps and spasm, arthralgia. Miscellaneous Diaphoresis, flushing and weakness.

adverse reactions

Allergic Allergic reactions and anaphylaxis.

adverse reactions

Neurologic Dizziness, convulsions, loss of consciousness, drowsiness, headache, dysarthria, miosis and visual changes.

adverse reactions

Cardiovascular Cardiac arrhythmias (including bradycardia, tachycardia, atrioventricular block and nodal rhythm) and nonspecific electrocardiogram changes have been reported, as well as cardiac arrest, syncope and hypotension. These have been predominantly noted following the use of the injectable form of neostigmine methylsulfate.

Reported adverse events (FAERS/openFDA)#

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