FDA label 2902cf07-ef09-47ec-bb0c-ce0fada8d67a

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
ea91db23-5c69-4bbf-887d-7979aef93822
SPL ID
2902cf07-ef09-47ec-bb0c-ce0fada8d67a
Version
2
Effective date
2013-12-10
Source export date
2026-08-01
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/2026-08-01/5a565ce64c898c83223b815b9579cd46fb0c6d54977c3cace2133e40124f7fbb/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:09:20

Warnings cross-check#

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warnings

WARNINGS Neostigmine 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 are administered, the prior or simultaneous injection of atropine sulfate may be advisable. Separate syringes should be used for neostigmine 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#

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Adverse reactions sections page 1 of 1 · 1 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 methylsulfate. Allergic: Allergic reaction and anaphylaxis. Neurologic: Dizziness, convulsions, loss of consciousness, drowsiness, headache, dysarthria, miosis and visual changes. Cardiovascular: Cardiac arrhythmias (including bradycardia, tachycardia, A-V block and nodal rhythm) and nonspecific EKG 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. 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 spasms, arthralgia. Miscellaneous: Diaphoresis, flushing and weakness.