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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.

DIGITALIS: 21 Adverse Event Reports & Safety Profile

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21
Total FAERS Reports
4 (19.0%)
Deaths Reported
17
Hospitalizations
21
As Primary/Secondary Suspect
4
Life-Threatening
3
Disabilities
Rxhomeo Private Limited d.b...
Manufacturer

Route: ORAL · Manufacturer: Rxhomeo Private Limited d.b.a. Rxhomeo, Inc · HUMAN OTC DRUG · FDA Label: Available

First Report: 20140528 · Latest Report: 20190406

What Are the Most Common DIGITALIS Side Effects?

#1 Most Reported
Drug ineffective
6 reports (28.6%)
#2 Most Reported
Cardiac failure
5 reports (23.8%)
#3 Most Reported
Ventricular fibrillation
4 reports (19.0%)

All DIGITALIS Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 6 28.6% 0 6
Cardiac failure 5 23.8% 0 4

Who Reports DIGITALIS Side Effects? Age & Gender Data

Gender: 64.3% female, 35.7% male. Average age: 67.2 years. Most reports from: US. View detailed demographics →

Is DIGITALIS Getting Safer? Reports by Year

YearReportsDeathsHosp.
2014 1 0 1
2016 1 0 1
2017 1 1 1
2019 1 0 1

View full timeline →

What Is DIGITALIS Used For?

IndicationReports
Product used for unknown indication 14

Official FDA Label for DIGITALIS

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Indications & dosage: Referred to enclosed self help guide or as advised by a homoeopathic physician.

Dosage & Administration

DOSAGE Adults: Mix 4-6 drops in 1/2 cup of water, take orally three times daily or as directed by a physician. Children (2 years and older): Take half the adult dose.

Contraindications

Care & contra-indications: This is a homoeopathic remedy, no contra-indications are established.

Warnings

WARNINGS This product is to be used for self-limiting conditions If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product Keep this and all medication out of reach of children Do not use if capseal is broken or missing. Close the cap tightly after use.

Active Ingredient

Digitalis purpurea 200CK (**contains 0.443 mg of the active ingredient per pellet)

Inactive Ingredients

INACTIVE INGREDIENTS Active: As Above; Inactive: ENA 50% v/v and Purified Water q.s.