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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.

AMINOSALICYLIC ACID: 2,007 Adverse Event Reports & Safety Profile

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2,007
Total FAERS Reports
814 (40.6%)
Deaths Reported
797
Hospitalizations
2,007
As Primary/Secondary Suspect
476
Life-Threatening
389
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
Yes
Generic Available

FDA Application: 006811 ·

First Report: 20080101 · Latest Report: 20241213

What Are the Most Common AMINOSALICYLIC ACID Side Effects?

#1 Most Reported
Off label use
448 reports (22.3%)
#2 Most Reported
Weight decreased
412 reports (20.5%)
#3 Most Reported
Drug ineffective
409 reports (20.4%)

All AMINOSALICYLIC ACID Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 448 22.3% 167 235
Weight decreased 412 20.5% 238 208
Drug ineffective 409 20.4% 95 218
Condition aggravated 401 20.0% 256 217
Pyrexia 399 19.9% 241 240
Pain 384 19.1% 212 190
Headache 381 19.0% 227 213
Colitis ulcerative 375 18.7% 135 233
Abdominal discomfort 358 17.8% 245 197
Frequent bowel movements 354 17.6% 138 218
Fatigue 353 17.6% 228 194
Rash 348 17.3% 215 166
Depression 342 17.0% 213 168
Vomiting 336 16.7% 246 190
Rectal haemorrhage 332 16.5% 135 204
Confusional state 327 16.3% 221 174
Systemic lupus erythematosus 323 16.1% 229 185
Diarrhoea 303 15.1% 231 205
Nausea 303 15.1% 188 161
Arthritis 297 14.8% 173 122

Who Reports AMINOSALICYLIC ACID Side Effects? Age & Gender Data

Gender: 61.7% female, 38.3% male. Average age: 41.4 years. Most reports from: CA. View detailed demographics →

Is AMINOSALICYLIC ACID Getting Safer? Reports by Year

YearReportsDeathsHosp.
2008 30 0 3
2010 1 0 0
2011 2 0 2
2012 1 0 1
2013 6 2 5
2014 13 1 4
2015 33 6 16
2016 67 23 31
2017 101 35 57
2018 257 90 85
2019 155 27 39
2020 13 0 8
2021 2 0 1
2022 13 2 5
2023 5 0 1
2024 3 0 1

View full timeline →

What Is AMINOSALICYLIC ACID Used For?

IndicationReports
Product used for unknown indication 886
Tuberculosis 760
Pulmonary tuberculosis 129
Colitis ulcerative 89
Deep vein thrombosis 44
Crohn's disease 34
Rheumatoid arthritis 16
Ankylosing spondylitis 12
Psoriasis 12
Psoriatic arthropathy 12

AMINOSALICYLIC ACID vs Alternatives: Which Is Safer?

AMINOSALICYLIC ACID vs AMIODARONE AMINOSALICYLIC ACID vs AMISULPRIDE AMINOSALICYLIC ACID vs AMITRIPTYLINE AMINOSALICYLIC ACID vs AMITRIPTYLINE\PERPHENAZINE AMINOSALICYLIC ACID vs AMIVANTAMAB AMINOSALICYLIC ACID vs AMIVANTAMAB-VMJW AMINOSALICYLIC ACID vs AMLODIPINE AMINOSALICYLIC ACID vs AMLODIPINE BESILATE AMINOSALICYLIC ACID vs AMLODIPINE\ATORVASTATIN AMINOSALICYLIC ACID vs AMLODIPINE\BENAZEPRIL

Official FDA Label for AMINOSALICYLIC ACID

Official prescribing information from the FDA-approved drug label.