Skip to content
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.

AMINOSALICYLATE: 272 Adverse Event Reports & Safety Profile

Grow Your Own Natural Pharmacy at Home

Medicinal Garden Kit — 10 healing herbs, 4,818 seeds + step-by-step guide.

Get the Kit
272
Total FAERS Reports
203 (74.6%)
Deaths Reported
179
Hospitalizations
272
As Primary/Secondary Suspect
145
Life-Threatening
119
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
Yes
Generic Available

Active Ingredient: AMINOSALICYLATE CALCIUM · FDA Application: 006811 ·

First Report: 20010206 · Latest Report: 20241017

What Are the Most Common AMINOSALICYLATE Side Effects?

#1 Most Reported
Vomiting
146 reports (53.7%)
#2 Most Reported
Type 2 diabetes mellitus
138 reports (50.7%)
#3 Most Reported
Abdominal discomfort
121 reports (44.5%)

All AMINOSALICYLATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Vomiting 146 53.7% 136 118
Type 2 diabetes mellitus 138 50.7% 136 118
Abdominal discomfort 121 44.5% 116 112
Mobility decreased 120 44.1% 119 102
Decreased appetite 118 43.4% 112 107
Infusion related reaction 117 43.0% 115 103
Dizziness 116 42.7% 112 108
Hypertension 116 42.7% 114 102
Hypoaesthesia 116 42.7% 114 101
Fatigue 115 42.3% 108 103
Osteoarthritis 114 41.9% 114 98
Pneumonia 114 41.9% 106 96
Systemic lupus erythematosus 114 41.9% 112 93
Headache 113 41.5% 107 101
Helicobacter infection 113 41.5% 112 108
Swelling 113 41.5% 111 109
Blood cholesterol increased 112 41.2% 110 104
Fibromyalgia 112 41.2% 109 104
Nausea 112 41.2% 97 87
Rheumatoid factor positive 112 41.2% 110 90

Who Reports AMINOSALICYLATE Side Effects? Age & Gender Data

Gender: 82.2% female, 17.8% male. Average age: 43.7 years. Most reports from: CA. View detailed demographics →

Is AMINOSALICYLATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 0
2013 1 0 0
2014 5 0 1
2015 8 2 2
2016 6 1 2
2017 4 2 3
2018 14 7 5
2019 6 0 1
2020 1 0 1
2021 4 0 2
2022 2 0 0
2024 2 0 2

View full timeline →

What Is AMINOSALICYLATE Used For?

IndicationReports
Product used for unknown indication 187
Tuberculosis 34
Pulmonary tuberculosis 16
Rheumatoid arthritis 11
Antibiotic prophylaxis 5

AMINOSALICYLATE vs Alternatives: Which Is Safer?

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

Official FDA Label for AMINOSALICYLATE

Official prescribing information from the FDA-approved drug label.