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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.

DEXPANTHENOL: 471 Adverse Event Reports & Safety Profile

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471
Total FAERS Reports
105 (22.3%)
Deaths Reported
311
Hospitalizations
471
As Primary/Secondary Suspect
83
Life-Threatening
81
Disabilities
Laboratorios Quimica Son's,...
Manufacturer

Route: TOPICAL · Manufacturer: Laboratorios Quimica Son's, S.A. de C.V · HUMAN OTC DRUG · FDA Label: Available

First Report: 19911104 · Latest Report: 20230515

What Are the Most Common DEXPANTHENOL Side Effects?

#1 Most Reported
Gastrooesophageal reflux disease
172 reports (36.5%)
#2 Most Reported
Somnolence
158 reports (33.5%)
#3 Most Reported
Off label use
141 reports (29.9%)

All DEXPANTHENOL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Gastrooesophageal reflux disease 172 36.5% 21 157
Somnolence 158 33.6% 21 152
Off label use 141 29.9% 38 123
Coma 138 29.3% 1 136
Pneumonia aspiration 137 29.1% 0 136
Drug ineffective 89 18.9% 26 78
Nausea 79 16.8% 28 69
Pain 74 15.7% 17 59
Abdominal pain 72 15.3% 27 65
Headache 67 14.2% 17 59
Constipation 64 13.6% 20 57
Pyrexia 61 13.0% 12 57
Vomiting 61 13.0% 37 36
Anaemia 60 12.7% 19 57
Infusion related reaction 56 11.9% 17 56
Drug intolerance 55 11.7% 30 42
Malaise 55 11.7% 11 52
Erythema 50 10.6% 0 46
Weight decreased 50 10.6% 6 49
Condition aggravated 48 10.2% 47 43

Who Reports DEXPANTHENOL Side Effects? Age & Gender Data

Gender: 74.5% female, 25.5% male. Average age: 61.5 years. Most reports from: CA. View detailed demographics →

Is DEXPANTHENOL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 7 1 2
2010 2 0 2
2013 4 0 2
2014 4 1 3
2015 4 1 4
2016 3 1 3
2017 21 10 3
2018 21 1 11
2019 13 3 1
2020 5 4 4
2021 6 2 3
2023 3 3 3

View full timeline →

What Is DEXPANTHENOL Used For?

IndicationReports
Product used for unknown indication 295
Constipation 33
Foetal exposure during pregnancy 13
Retinal artery occlusion 6
Bronchospasm 5
Dry mouth 5

DEXPANTHENOL vs Alternatives: Which Is Safer?

DEXPANTHENOL vs DEXRAZOXANE DEXPANTHENOL vs DEXTRAN 70\HYPROMELLOSE 2910 DEXPANTHENOL vs DEXTROAMPHETAMINE DEXPANTHENOL vs DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE AND AMPHETAMINE DEXPANTHENOL vs DEXTROMETHORPHAN DEXPANTHENOL vs DEXTROMETHORPHAN HYDROBROMIDE DEXPANTHENOL vs DEXTROMETHORPHAN HYDROBROMIDE\GUAIFENESIN DEXPANTHENOL vs DEXTROMETHORPHAN HYDROBROMIDE\GUAIFENESIN\PHENYLEPHRINE DEXPANTHENOL vs DEXTROMETHORPHAN HYDROBROMIDE\QUINIDINE DEXPANTHENOL vs DEXTROMETHORPHAN\GUAIFENESIN

Official FDA Label for DEXPANTHENOL

Official prescribing information from the FDA-approved drug label.

Drug Description

DESCRIPTION Vitamin B-Complex 100 Injection is a sterile solution for intramuscular or slow intravenous injection comprised of vitamins which may be categorized as belonging to the vitamin B complex group. Each mL contains: Thiamine Hydrochloride 100 mg, Riboflavin 5’ Phosphate Sodium 2 mg, Pyridoxine Hydrochloride 2 mg, Dexpanthenol 2 mg, Niacinamide 100 mg, with Benzyl Alcohol 2% as preservative, in Water for Injection.

Sodium

Hydroxide and/or Hydrochloric Acid may have been used to adjust pH.

FDA Approved Uses (Indications)

INDICATIONS AND USAGE In disorders requiring parenteral administration of vitamins, i.e. pre- and post-operative treatment, when requirements are increased as in fever, severe burns, increased metabolism, pregnancy, gastrointestinal disorders interfering with intake or absorption of vitamins, prolonged or wasting diseases, alcoholism and where other deficiencies exist.

Dosage & Administration

DOSAGE AND ADMINISTRATION Usually 0.25 to 2 mL by intramuscular or slow intravenous injection. High concentrations given intravenously may be diluted using parenteral infusion solutions. (See PRECAUTIONS .) Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit (see HOW SUPPLIED ).

Contraindications

CONTRAINDICATIONS Sensitivity to the ingredients listed.

Known Adverse Reactions

ADVERSE REACTIONS Mild transient diarrhea, polycythemia vera, peripheral vascular thrombosis, itching transitory exanthema, feeling of swelling of entire body, anaphylactic shock and death. Sensitivity to the ingredients listed may occur (see WARNINGS ). Use should be discontinued upon observance of any untoward reaction. Pain upon intramuscular injection may be noted.

Warnings

Warnings For external use only When using this product do not get into eyes. Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Precautions

PRECAUTIONS The usual precautions for parenteral administration should be observed. Do not inject if precipitation occurs. Inject slowly by the intravenous route. High concentrations should be diluted using Normal Saline Injection when given intravenously.

Active Ingredient

Active ingredient Dexpanthenol 5% Purpose Skin Protectant

Inactive Ingredients

Inactive ingredients anhydrous lanolin, beeswax, cetyl alcohol, polysorbate 60, polysorbate 80, stearyl alcohol, water, white petrolatum, zinc oxide