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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.

FORMALDEHYDE: 43 Adverse Event Reports & Safety Profile

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43
Total FAERS Reports
2 (4.7%)
Deaths Reported
7
Hospitalizations
43
As Primary/Secondary Suspect
5
Life-Threatening
4
Disabilities
Boiron
Manufacturer

Drug Class: Allergens [CS] · Route: ORAL · Manufacturer: Boiron · HUMAN OTC DRUG · FDA Label: Available

First Report: 200911 · Latest Report: 20250101

What Are the Most Common FORMALDEHYDE Side Effects?

#1 Most Reported
Drug hypersensitivity
25 reports (58.1%)
#2 Most Reported
Fatigue
12 reports (27.9%)
#3 Most Reported
Influenza
10 reports (23.3%)

All FORMALDEHYDE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug hypersensitivity 25 58.1% 0 1
Fatigue 12 27.9% 0 1
Influenza 10 23.3% 0 2
Allergy to chemicals 9 20.9% 0 1
Blood test abnormal 8 18.6% 0 0
Infusion related reaction 8 18.6% 0 0
Joint stiffness 8 18.6% 0 0
Parathyroid hyperplasia 8 18.6% 0 0
Pharyngitis streptococcal 8 18.6% 0 0
Respiratory rate increased 8 18.6% 0 0

Who Reports FORMALDEHYDE Side Effects? Age & Gender Data

Gender: 86.5% female, 13.5% male. Average age: 47.1 years. Most reports from: US. View detailed demographics →

Is FORMALDEHYDE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2009 1 0 0
2013 1 1 0
2016 2 0 1
2018 1 0 0
2019 4 0 1
2023 1 0 1
2024 1 0 1
2025 3 0 3

View full timeline →

What Is FORMALDEHYDE Used For?

IndicationReports
Product used for unknown indication 21

Other Drugs in Same Class: Allergens [CS]

Official FDA Label for FORMALDEHYDE

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

USES:

  • For the temporary relief of symptoms including:
  • burning eyes
  • crying
  • dizziness
  • muscle spasms
  • shakiness These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Dosage & Administration

DIRECTIONS Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

Warnings

WARNINGS: If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.

Tamper

Evident: Sealed for your protection. Do not use if seal is broken or missing.

Active Ingredient

FORMALINUM 200CK HPUS Active ingredient**: See product name on front panel (contains 0.443 mg of the active ingredient per pellet).

Inactive Ingredients

INACTIVE INGREDIENTS: Demineralized water, 25% ethanol