ADEMETIONINE: 111 Adverse Event Reports & Safety Profile
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Route: ORAL · Manufacturer: Professional Complementary Health Formulas · HUMAN OTC DRUG · FDA Label: Available
First Report: 20090217 · Latest Report: 20250527
What Are the Most Common ADEMETIONINE Side Effects?
All ADEMETIONINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug abuse | 18 | 16.2% | 0 | 7 |
| Drug interaction | 17 | 15.3% | 1 | 15 |
| Serotonin syndrome | 17 | 15.3% | 0 | 16 |
| Foetal exposure during pregnancy | 14 | 12.6% | 0 | 7 |
| Rhabdomyolysis | 14 | 12.6% | 0 | 13 |
| Product use in unapproved indication | 13 | 11.7% | 3 | 12 |
| Pyrexia | 13 | 11.7% | 3 | 13 |
| Confusional state | 12 | 10.8% | 0 | 11 |
| Premature baby | 12 | 10.8% | 0 | 7 |
| Sopor | 11 | 9.9% | 0 | 0 |
| Tachycardia | 11 | 9.9% | 0 | 11 |
| Confabulation | 10 | 9.0% | 0 | 10 |
| Dyskinesia | 10 | 9.0% | 0 | 10 |
| Hypokalaemia | 10 | 9.0% | 0 | 10 |
| Nystagmus | 10 | 9.0% | 0 | 10 |
| Renal failure | 10 | 9.0% | 0 | 10 |
| Agitation | 9 | 8.1% | 0 | 9 |
| Hypomagnesaemia | 9 | 8.1% | 0 | 9 |
| Abdominal pain | 8 | 7.2% | 0 | 0 |
| Blood creatine phosphokinase increased | 8 | 7.2% | 0 | 8 |
Who Reports ADEMETIONINE Side Effects? Age & Gender Data
Gender: 77.3% female, 22.7% male. Average age: 46.8 years. Most reports from: IT. View detailed demographics →
Is ADEMETIONINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2009 | 1 | 0 | 1 |
| 2015 | 13 | 0 | 1 |
| 2016 | 1 | 0 | 0 |
| 2017 | 1 | 0 | 0 |
| 2018 | 2 | 0 | 1 |
| 2019 | 12 | 0 | 9 |
| 2020 | 5 | 0 | 5 |
| 2021 | 11 | 3 | 10 |
| 2022 | 14 | 0 | 6 |
| 2023 | 1 | 0 | 0 |
| 2024 | 2 | 0 | 1 |
| 2025 | 1 | 0 | 1 |
What Is ADEMETIONINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 33 |
| Depression | 30 |
| Cholestasis | 7 |
| Major depression | 5 |
ADEMETIONINE vs Alternatives: Which Is Safer?
Official FDA Label for ADEMETIONINE
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
INDICATIONS: Provides potentized homeo-nutritional support for the body's natural ability to methylate properly.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Dosage & Administration
DIRECTIONS Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take one full dropper up to 2 times per day. Consult a physician for use in children under 12 years of age.
Warnings
WARNINGS Consult a doctor if condition worsens or if symptoms persist. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use. Keep out of the reach of children. If pregnant or breastfeeding, ask a healthcare professional before use.
Active Ingredient
ACTIVE INGREDIENTS: Inositol 6X, 12X, Methylcobalamin (Vitamin B12) 6X, 12X, Nadidum (NADH) 6X, 12X, Niacin (Nicotinic Acid) 6X, 12X, Nicotinamidum (Niacinamide) 6X, 12X, L-Methionine 6X, 12X, Pyridoxinum Hydrochloricum (Vitamin B6) 6X, 12X, SAMe (S-Adenosyl Methionine) 6X, 12X, Zincum Gluconicum 6X, 12X, Magnesium Gluconicum Dihydricum 8X, 12X, Riboflavinum (Vitamin B2) 8X, 12X, Ubidecarenonum CoQ10) 8X, 12X, Dopamine 12X, Serotonin 12X, Egg White 15C, 30C.
Inactive Ingredients
INACTIVE INGREDIENTS: Alcohol USP 20%, Purified Water USP.