WHEAT GLUTEN: 94 Adverse Event Reports & Safety Profile
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Drug Class: Allergens [CS] · Route: ORAL · Manufacturer: Professional Complementary Health Formulas · HUMAN OTC DRUG · FDA Label: Available
First Report: 2008 · Latest Report: 20250401
What Are the Most Common WHEAT GLUTEN Side Effects?
All WHEAT GLUTEN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug hypersensitivity | 35 | 37.2% | 0 | 0 |
| Reaction to drug excipients | 17 | 18.1% | 0 | 0 |
| Gluten sensitivity | 12 | 12.8% | 0 | 0 |
| Diarrhoea | 10 | 10.6% | 0 | 0 |
| Coeliac disease | 8 | 8.5% | 0 | 0 |
| Headache | 8 | 8.5% | 0 | 0 |
| Abdominal distension | 7 | 7.5% | 0 | 0 |
| Condition aggravated | 7 | 7.5% | 0 | 0 |
| Fatigue | 7 | 7.5% | 0 | 0 |
| Malaise | 7 | 7.5% | 0 | 0 |
| Reaction to excipient | 7 | 7.5% | 0 | 0 |
| Arthralgia | 6 | 6.4% | 0 | 0 |
| Hypersensitivity | 6 | 6.4% | 0 | 0 |
| Pruritus | 6 | 6.4% | 0 | 0 |
| Nausea | 5 | 5.3% | 0 | 0 |
| Product label issue | 5 | 5.3% | 0 | 0 |
| Rash | 5 | 5.3% | 0 | 0 |
Who Reports WHEAT GLUTEN Side Effects? Age & Gender Data
Gender: 86.0% female, 14.0% male. Average age: 57.1 years. Most reports from: US. View detailed demographics →
Is WHEAT GLUTEN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2008 | 1 | 0 | 0 |
| 2014 | 1 | 0 | 0 |
| 2015 | 3 | 0 | 0 |
| 2016 | 5 | 0 | 0 |
| 2017 | 5 | 0 | 0 |
| 2018 | 1 | 0 | 0 |
| 2019 | 1 | 0 | 0 |
| 2020 | 1 | 0 | 0 |
| 2022 | 2 | 0 | 0 |
| 2023 | 2 | 0 | 0 |
| 2024 | 2 | 0 | 0 |
| 2025 | 2 | 0 | 0 |
What Is WHEAT GLUTEN Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 31 |
Other Drugs in Same Class: Allergens [CS]
Official FDA Label for WHEAT GLUTEN
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
INDICATIONS For the temporary relief of gas, bloating, diarrhea, and itching of the nose or throat due to sensitivity to gluten.*
Dosage & Administration
DIRECTIONS Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 to 15 drops up to 3 times per day. For desensitization, begin with 1 to 5 drops daily, increasing to the standard dose gradually to avoid symptom expression; after 1 to 3 months at the standard dose, decrease gradually to a maintenance dose of 10 to 15 drops weekly. Consult a physician for use in children under 12 years of age.
Warnings
WARNINGS In case of overdose, get medical help or contact a poison control center right away. Keep out of the reach of children. If pregnant or breastfeeding, ask a healthcare professional before use.
Active Ingredient
ACTIVE INGREDIENTS Gluten 6X, 12X, 30X
Inactive Ingredients
INACTIVE INGREDIENTS 20% ethanol, purified water.