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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.

PHENYLALANINE: 27 Adverse Event Reports & Safety Profile

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27
Total FAERS Reports
4 (14.8%)
Deaths Reported
16
Hospitalizations
27
As Primary/Secondary Suspect
13
Life-Threatening
Energique, Inc.
Manufacturer

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

First Report: 20170412 · Latest Report: 20210909

What Are the Most Common PHENYLALANINE Side Effects?

#1 Most Reported
Rhabdomyolysis
13 reports (48.1%)
#2 Most Reported
Vasoplegia syndrome
12 reports (44.4%)
#3 Most Reported
Pulse absent
12 reports (44.4%)

All PHENYLALANINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Rhabdomyolysis 13 48.2% 0 13
Bradycardia 12 44.4% 0 12
Cardiac arrest 12 44.4% 0 12
Cardiogenic shock 12 44.4% 0 12
Coma scale abnormal 12 44.4% 0 12
Compartment syndrome 12 44.4% 0 12
Condition aggravated 12 44.4% 0 12
Hyperkalaemia 12 44.4% 0 12
Hypotension 12 44.4% 0 12
Ileus 12 44.4% 0 12
Lactic acidosis 12 44.4% 0 12
Overdose 12 44.4% 0 12
Pulse absent 12 44.4% 0 12
Vasoplegia syndrome 12 44.4% 0 12
Off label use 8 29.6% 0 8

Who Reports PHENYLALANINE Side Effects? Age & Gender Data

Gender: 35.0% female, 65.0% male. Average age: 48.2 years. Most reports from: CA. View detailed demographics →

Is PHENYLALANINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2017 1 0 0
2018 2 0 2
2019 1 0 0
2021 1 0 0

View full timeline →

What Is PHENYLALANINE Used For?

IndicationReports
Overdose 11

Official FDA Label for PHENYLALANINE

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

INDICATIONS: May temporarily relieve symptoms associated with reactions to phenylalanine.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage & Administration

DIRECTIONS: Adults and children 5 to 10 drops orally, 1 time daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Warnings

WARNINGS: If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in cool, dry place.

Active Ingredient

ACTIVE INGREDIENT: (in each drop): 20% of Phenylalanine 6X, 12X, 30X, 12C, 30C.

Inactive Ingredients

INACTIVE INGREDIENTS: Demineralized Water, 25% Ethanol.