AMMONIA: 62 Adverse Event Reports & Safety Profile
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Route: RESPIRATORY (INHALATION) · Manufacturer: James Alexander Corporation · HUMAN OTC DRUG · FDA Label: Available
First Report: 20110803 · Latest Report: 20250614
What Are the Most Common AMMONIA Side Effects?
All AMMONIA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Seizure | 15 | 24.2% | 0 | 8 |
| Vomiting | 15 | 24.2% | 0 | 4 |
| Dyspnoea | 14 | 22.6% | 0 | 4 |
| Migraine | 10 | 16.1% | 0 | 3 |
| Toxicity to various agents | 8 | 12.9% | 5 | 2 |
| Cough | 6 | 9.7% | 0 | 0 |
| Diarrhoea | 6 | 9.7% | 0 | 1 |
| Drug abuse | 6 | 9.7% | 0 | 6 |
| Eye irritation | 6 | 9.7% | 0 | 0 |
| Gastric disorder | 6 | 9.7% | 0 | 1 |
| Syncope | 6 | 9.7% | 0 | 2 |
| Accidental exposure to product | 5 | 8.1% | 1 | 4 |
| Anxiety | 5 | 8.1% | 0 | 0 |
| Chest pain | 5 | 8.1% | 0 | 0 |
| Depression | 5 | 8.1% | 0 | 2 |
| Dizziness | 5 | 8.1% | 0 | 1 |
| Drug ineffective | 5 | 8.1% | 0 | 1 |
| Respiratory disorder | 5 | 8.1% | 0 | 1 |
| Throat irritation | 5 | 8.1% | 0 | 0 |
Who Reports AMMONIA Side Effects? Age & Gender Data
Gender: 42.6% female, 57.4% male. Average age: 31.5 years. Most reports from: US. View detailed demographics →
Is AMMONIA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 1 | 0 | 0 |
| 2012 | 1 | 0 | 0 |
| 2014 | 4 | 3 | 0 |
| 2015 | 1 | 0 | 0 |
| 2017 | 1 | 0 | 1 |
| 2018 | 1 | 0 | 0 |
| 2020 | 1 | 0 | 1 |
| 2022 | 7 | 0 | 2 |
| 2023 | 16 | 1 | 5 |
| 2024 | 3 | 0 | 1 |
| 2025 | 7 | 0 | 6 |
What Is AMMONIA Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 22 |
Official FDA Label for AMMONIA
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Avoid contact with eyes, ears, and mouth. If product gets into eyes, rinse thoroughly with water for 15 minutes. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Dosage & Administration
Directions Hold bottle 10-15 cm (4-6 inches) from nostrils. Inhale gently. Do not place directly inside the nostrils. Do not inhale for more than 2 seconds per use. Do not use more than once every 60 minutes. Do not use more than 10 times per day. Use only as needed. If symptoms persist, consult a healthcare professional.
Warnings
Warnings For inhalation use only. Do not ingest or apply to skin. Use only in a well-ventilated area. Do not use in enclosed spaces. Avoid contact with eves. ears, and mouth. If product gets into eyes, rinse thoroughly with water for 15 minutes and seek medical help. May cause nasal irritation, coughing, or shortness of breath. Discontinue use if discomfort occurs and get fresh air immediately. Not recommended for individuals with: respiratory conditions (such as asthma or emphysema), heart disease, high blood pressure, or allergy to ammonia or strong odors.
Active Ingredient
Active Ingredient (s) ammonium carbonate 15% eucalyptus oil 10% ammonia 15%
Inactive Ingredients
Inactive Ingredients Inactive ingredients Alcohol USP, FD&C Red Dye # 40, Lavender Oil FCC, Lemon Oil FCC, Nutmeg Oil FCC, Purified Water USP.