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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.

LACTOSE: 184 Adverse Event Reports & Safety Profile

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184
Total FAERS Reports
2 (1.1%)
Deaths Reported
18
Hospitalizations
184
As Primary/Secondary Suspect
3
Life-Threatening
2
Disabilities

First Report: 20050503 · Latest Report: 20241015

What Are the Most Common LACTOSE Side Effects?

#1 Most Reported
Drug hypersensitivity
82 reports (44.6%)
#2 Most Reported
Diarrhoea
25 reports (13.6%)
#3 Most Reported
Allergic reaction to excipient
24 reports (13.0%)

All LACTOSE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug hypersensitivity 82 44.6% 0 2
Diarrhoea 25 13.6% 0 7
Allergic reaction to excipient 24 13.0% 0 1
Reaction to excipient 23 12.5% 0 4
Urticaria 23 12.5% 0 1
Angioedema 20 10.9% 0 0
Condition aggravated 20 10.9% 0 3
Lactose intolerance 17 9.2% 0 3
Off label use 14 7.6% 0 0
Swelling face 14 7.6% 0 0
Drug intolerance 12 6.5% 0 0
Food allergy 12 6.5% 0 0
Nausea 12 6.5% 0 4
Abdominal pain 11 6.0% 0 3
Allergy to metals 11 6.0% 0 0
Asthenia 11 6.0% 0 6
Iodine allergy 11 6.0% 0 0
Rubber sensitivity 11 6.0% 0 0
Seasonal allergy 11 6.0% 0 0
Eye oedema 10 5.4% 0 0

Who Reports LACTOSE Side Effects? Age & Gender Data

Gender: 85.2% female, 14.8% male. Average age: 56.2 years. Most reports from: US. View detailed demographics →

Is LACTOSE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2005 1 1 1
2009 1 0 0
2012 1 0 0
2013 1 0 1
2014 1 0 0
2015 3 0 1
2016 4 0 0
2017 21 0 0
2018 4 0 1
2019 7 1 2
2020 4 0 1
2021 3 0 0
2022 3 0 1
2023 5 0 1
2024 6 0 2

View full timeline →

What Is LACTOSE Used For?

IndicationReports
Product used for unknown indication 69

LACTOSE vs Alternatives: Which Is Safer?

LACTOSE vs LACTULOSE LACTOSE vs LAMICTAL LACTOSE vs LAMIVUDINE LACTOSE vs LAMIVUDINE\NEVIRAPINE\ZIDOVUDINE LACTOSE vs LAMIVUDINE\TENOFOVIR LACTOSE vs LAMIVUDINE\TENOFOVIR DISOPROXIL LACTOSE vs LAMIVUDINE\ZIDOVUDINE LACTOSE vs LAMOTRIGINE LACTOSE vs LANADELUMAB LACTOSE vs LANADELUMAB-FLYO

Official FDA Label for LACTOSE

Official prescribing information from the FDA-approved drug label.