FDA label 6302eb02-3520-4ebd-bebd-ec3a7c8bbc3c

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
39ead516-1ff7-4d91-a9e8-aeb1e17a428b
SPL ID
6302eb02-3520-4ebd-bebd-ec3a7c8bbc3c
Version
2
Effective date
2013-10-23
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 05:29:52

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, USP 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 the Neostigmine and Atropine. Because of the possibility of hypersensitivity in an occasional patient, Atropine and anti-shock 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 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 reactions 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 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 spasms, arthralgia. Miscellaneous : Diaphoresis, flushing and weakness.

Reported adverse events (FAERS/openFDA)#

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