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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.

AMYL NITRITE: 38 Adverse Event Reports & Safety Profile

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38
Total FAERS Reports
2 (5.3%)
Deaths Reported
22
Hospitalizations
38
As Primary/Secondary Suspect
7
Life-Threatening
3
Disabilities
Deseret Biologicals, Inc.
Manufacturer

Route: ORAL · Manufacturer: Deseret Biologicals, Inc. · HUMAN OTC DRUG · FDA Label: Available

First Report: 20160410 · Latest Report: 20241028

What Are the Most Common AMYL NITRITE Side Effects?

#1 Most Reported
Methaemoglobinaemia
15 reports (39.5%)
#2 Most Reported
Drug interaction
9 reports (23.7%)
#3 Most Reported
Drug abuse
7 reports (18.4%)

All AMYL NITRITE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Methaemoglobinaemia 15 39.5% 0 13
Drug interaction 9 23.7% 0 5
Agitation 7 18.4% 0 7
Drug abuse 7 18.4% 1 2
Dysstasia 6 15.8% 0 6
Logorrhoea 6 15.8% 0 6
Muscular weakness 6 15.8% 0 6
Skin discolouration 6 15.8% 0 6
Somnolence 6 15.8% 0 6
Tachyphrenia 6 15.8% 0 6
Toxicity to various agents 6 15.8% 1 4

Who Reports AMYL NITRITE Side Effects? Age & Gender Data

Gender: 11.4% female, 88.6% male. Average age: 39.0 years. Most reports from: US. View detailed demographics →

Is AMYL NITRITE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2016 4 0 2
2020 2 1 2
2021 3 0 1
2022 3 0 0
2023 2 0 1
2024 2 0 2

View full timeline →

What Is AMYL NITRITE Used For?

IndicationReports
Product used for unknown indication 21

Official FDA Label for AMYL NITRITE

Official prescribing information from the FDA-approved drug label.

Drug Description

DESCRIPTION: Amyl nitrite is a rapidly acting vasodilator administered by inhalation. 0.3mL is supplied in a covered thin glass capsule which is easily crushed between the fingers. Amyl nitrite is a clear, yellowish liquid having a peculiar ethereal, fruity odor. It is volatile, even at low temperatures, and is flammable. This product is stabilized with Linseed Oil Epoxy. The structural formula of amyl nitrite is: (CH 3 ) 2 CHCH 2 CH 2 ONO

FDA Approved Uses (Indications)

HOMEOPATHIC INDICATIONS: For temporary relief of symptoms related to a reaction to pollens or dust including sneezing, congestion, stomach discomfort, lethargy and cough.** **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Dosage & Administration

DOSAGE & ADMINISTRATION: With the patient in recumbent or seated position a capsule of amyl nitrite is held away from the face, crushed between the fingers, and held under the patient's nose. Two to six inhalations of the vapors from the capsule are usually sufficient to promptly produce therapeutic effects. Caution is recommended to avoid inhalation of excessive amounts of the drug when it is administered by someone other than the patient. If necessary, the dose may be repeated in 3 to 5 minutes.

Contraindications

CONTRAINDICATIONS: Since it may increase intraocular and intracranial pressures, amyl nitrite is contraindicated or should be used with great caution in patients with glaucoma, recent head trauma or cerebral hemorrhage. Amyl nitrite can cause harm to the fetus when it is administered to a pregnant woman because it significantly reduces systemic blood pressure and blood flow on the maternal side of the placenta.

Known Adverse Reactions

ADVERSE REACTIONS: Mild transitory headache, dizziness and flushing of the face are common with the use of amyl nitrite. The following adverse reactions may occur in susceptible patients: syncope, involuntary passing of urine and feces, hypotension, pallor, cold sweat, tachycardia, restlessness, weakness, vomiting and nausea. Excessively high doses of amyl nitrite administered chronically may cause methemoglobinemia.

Warnings

Warnings and Storage: Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms. Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE NOT FDA EVALUATED. This product is not intended to diagnose, treat, cure, or prevent any disease.

Precautions

CAUTION : Amyl nitrite is very flammable. Do not use where it might become ignited. Keep away from open flame or sparks. PRECAUTIONS : Genera l - Tolerance to amyl nitrite may develop with repeated use of the drug for prolonged periods of time. Tolerance may be minimized by beginning with the smallest effective dose and alternating the drug with another coronary vasodilator. High doses of nitrites may produce methemoglobinemia, especially in individuals with methemoglobin reductase deficiency or other metabolic abnormality that interferes with the normal conversion of methemoglobin back to haemoglobin.

Patient

Information - Amyl nitrite should be taken by the patient when seated or lying down.

Drug

Interactions - Taking amyl nitrite after drinking alcohol may worsen side effects and may cause severe hypotension and cardiovascular collapse. Carcinogenesis, Mutagenesis, Fertility Impairment - Adequate long term studies to establish adverse carcinogenic potential of this drug have not been reported. Pregnancy - Teratogenic effects: Category C. Animal studies have not been conducted with amyl nitrite. It is also not known whether amyl nitrite can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Amyl nitrite should be given to a pregnant woman only if clearly needed.

Nursing

Mothers - It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when amyl nitrite is administered to a nursing woman.

Pediatric

Use - Safety and effectiveness in children have not been established.

Active Ingredient

ACTIVE INGREDIENTS: Amyl Nitrosum 6X, Euphrasia Officinalis 6X, Kali Muriaticum 6X, Wyethia Helenoides 6X, Histaminum Hydrochloricum 6X, 12X, 15X, 30X, Lac Caninum 6X, 12X, 15X, 30X, Glandula Suprarenalis Suis 8X, Mucosa Nasalis Suis 8X, Allium Cepa 12X, Arsenicum Album 12X, Blatta Americana 12X, Iridium Metallicum 12X, Sabadilla 12X, Selenium Metallicum 12X, Lac Felinum 12X 15X, 30X, Hyaluronidase 30X, Interferon (Suis) 30X, Serotonin (Hydrochloride) 30X, House Dust Mite 9C, 12C, 15C, 30C.

Inactive Ingredients

INACTIVE INGREDIENTS: Demineralized Water, 25% Ethanol