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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ACETYLCHOLINE: 68 Adverse Event Reports & Safety Profile

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68
Total FAERS Reports
2 (2.9%)
Deaths Reported
46
Hospitalizations
68
As Primary/Secondary Suspect
1
Life-Threatening
1
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Professional Complementary ...
Manufacturer
Discontinued
Status

Active Ingredient: ACETYLCHOLINE CHLORIDE · Drug Class: Cholinergic Agonists [MoA] · Route: ORAL · Manufacturer: Professional Complementary Health Formulas · FDA Application: 016211 · HUMAN OTC DRUG · FDA Label: Available

First Report: 20070201 · Latest Report: 20210601

What Are the Most Common ACETYLCHOLINE Side Effects?

#1 Most Reported
Sinusitis
34 reports (50.0%)
#2 Most Reported
Rhinorrhoea
34 reports (50.0%)
#3 Most Reported
Dyspnoea
34 reports (50.0%)

All ACETYLCHOLINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Cough 34 50.0% 0 34
Dyspnoea 34 50.0% 0 34
Rhinorrhoea 34 50.0% 0 33
Sinusitis 34 50.0% 0 33
Anxiety 33 48.5% 0 33
Asthma 33 48.5% 0 33
Breast cancer 33 48.5% 0 33
Chest discomfort 33 48.5% 0 33
Chronic obstructive pulmonary disease 33 48.5% 0 33
Depression 33 48.5% 0 33
Eosinophilia 33 48.5% 0 33
Hypertension 33 48.5% 0 33
Malaise 33 48.5% 0 33
Mental disorder 33 48.5% 0 33
Mental impairment 33 48.5% 0 33
Obstruction 33 48.5% 0 33
Pneumonia 33 48.5% 0 33
Productive cough 33 48.5% 0 33
Respiratory disorder 33 48.5% 0 33
Sinus disorder 33 48.5% 0 33

Who Reports ACETYLCHOLINE Side Effects? Age & Gender Data

Gender: 83.8% female, 16.3% male. Average age: 57.9 years. Most reports from: CA. View detailed demographics →

Is ACETYLCHOLINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2007 1 0 0
2010 1 0 1
2013 1 0 1
2016 1 0 0
2017 6 0 3
2018 1 0 1
2020 2 0 0
2021 1 0 0

View full timeline →

What Is ACETYLCHOLINE Used For?

IndicationReports
Product used for unknown indication 42
Miosis 6
Cataract operation 5

Other Drugs in Same Class: Cholinergic Agonists [MoA]

VARENICLINE (20,408) PILOCARPINE (1,782) METHACHOLINE (36) CARBACHOL (35) View all → Class side effects → Compare in class →

Official FDA Label for ACETYLCHOLINE

Official prescribing information from the FDA-approved drug label.

Drug Description

DESCRIPTION Miochol ™ -E (acetylcholine chloride intraocular solution) is a parasympathomimetic preparation for intraocular use. It is packaged in a blister pack containing one vial and one diluent ampule. The vial contains 20 mg acetylcholine chloride and 56 mg mannitol. The accompanying ampule contains 2 mL of a modified diluent of calcium chloride dihydrate, magnesium chloride hexahydrate, potassium chloride, sodium acetate trihydrate, and sterile water for injection. The reconstituted liquid will be a sterile isotonic solution (275–330 milliosmoles/kg) containing 20 mg acetylcholine chloride (1:100 solution) and 2.8% mannitol. The pH range is 5.0–8.2. Mannitol is used in the process of lyophilizing acetylcholine chloride, and is not considered an active ingredient. The chemical name for acetylcholine chloride, C 7 H 16 ClNO 2 , is Ethanaminium, 2-(acetyloxy) -N,N,N -trimethyl-, chloride and is represented by the following chemical structure: ChemStructure

FDA Approved Uses (Indications)

USES:

  • For the temporary relief of symptoms including:
  • feelings of helplessness
  • sadness
  • difficulty sleeping
  • difficulty concentrating
  • irritability
  • loss of appetite
  • self loathing These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Dosage & Administration

DOSAGE AND ADMINISTRATION Miochol ™ -E (acetylcholine chloride intraocular solution) is instilled into the anterior chamber before or after securing one or more sutures. Instillation should be gentle and parallel to the iris face and tangential to pupil border. If there are no mechanical hindrances, the pupil starts to constrict in seconds and the peripheral iris is drawn away from the angle of the anterior chamber. Any anatomical hindrance to miosis must be released to permit the desired effect of the drug. In most cases, 0.5 to 2 mL produces satisfactory miosis. Note that the syringe filter supplied with Miochol-E has a priming volume of 0.6 mL (approximately). In cataract surgery, use Miochol-E only after delivery of the lens. Aqueous solutions of acetylcholine chloride are unstable. Prepare solution immediately before use. Do not use solution that is not clear and colorless. Discard any solution that has not been used.

Contraindications

CONTRAINDICATIONS Miochol-E is contraindicated in persons with a known hypersensitivity to any component of this product.

Known Adverse Reactions

ADVERSE REACTIONS Infrequent cases of corneal edema, corneal clouding, and corneal decompensation have been reported with the use of intraocular acetylcholine. Adverse reactions have been reported rarely, which are indicative of systemic absorption. These include bradycardia, hypotension, flushing, breathing difficulties, and sweating. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Warnings

WARNINGS: If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.

Tamper

Evident: Sealed for your protection. Do not use if seal is broken or missing. Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than two days or administer to children under 3 years of age unless directed by a physician.

Precautions

PRECAUTIONS General If miosis is to be obtained quickly with Miochol-E, anatomical hindrances to miosis, such as anterior or posterior synechiae, must be released, prior to administration of Miochol-E. During cataract surgery, use Miochol-E only after delivery of the lens. Aqueous solutions of acetylcholine chloride are unstable. Prepare solution immediately before use. Do not use solution which is not clear and colorless. Discard any solution that has not been used.

Drug Interactions

Although clinical studies with acetylcholine chloride and animal studies with acetylcholine or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine chloride and carbachol have been ineffective when used in patients treated with topical nonsteroidal anti-inflammatory agents.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Active Ingredient

ACTIVE INGREDIENTS: Acetylcholine Chloride 6X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Aesculus Hippocastanum 6X, Antimonium Tartaricum 6X, Ascorbicum Acidum 6X, Baryta Carbonica 28X, Calcarea Phosphorica 10X, Coccus Cacti 6X, Conium Maculatum 8X, Cortisone Aceticum 8X, Dulcamara 4X, Echinacea (Angustifolia) 4X, Funiculus Umbilicalis Suis 10X, Galium Aparine 6X, Gentiana Lutea 6X, Geranium Robertianum 6X, Glandula Suprarenalis Suis 13X, Hepar Suis 10X, Hypothalamus Suis 10X, Lymph Node (Suis) 8X, Mannose 6X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Medulla Ossis Suis 10X, Mercurius Solubilis 13X, Pulsatilla (Pratensis) 6X, Sarcolacticum Acidum 6X, Spleen (Suis) 10X, Sulphur 8X, Thyroidinum (Suis) 13X, Tonsil Suis 28X.

Inactive Ingredients

INACTIVE INGREDIENTS: Demineralized Water, 25% Ethanol.