Mesalamine

Common brands: Pentasa, Lialda, Apriso, Canasa, Rowasa

Top reporter: Takeda Pharmaceuticals America, Inc.

Aminosalicylate [EPC]Corticosteroid [EPC]Tumor Necrosis Factor Blocker [EPC]Integrin Receptor Antagonist [EPC]Purine Antimetabolite [EPC]
54,800
Total Reports
25,854
Serious Reports
2,632
Death Reports
30
Reported Reactions
Death Report Ratio: Moderate (4.80%)

Patient Demographics

Male
20,892
Female
28,230

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Mesalamine.

# Reaction Reports % of Total
1 OFF LABEL USE 9,022
10.0%
2 DRUG INEFFECTIVE 7,018
7.8%
3 COLITIS ULCERATIVE 6,525
7.2%
4 DIARRHOEA 4,840
5.3%
5 CONDITION AGGRAVATED 4,526
5.0%
6 FATIGUE 3,773
4.2%
7 ABDOMINAL PAIN 3,679
4.1%
8 HAEMATOCHEZIA 3,582
4.0%
9 NAUSEA 3,265
3.6%
10 HEADACHE 3,080
3.4%
11 ARTHRALGIA 2,898
3.2%
12 PYREXIA 2,855
3.2%
13 CROHN^S DISEASE 2,779
3.1%
14 WEIGHT DECREASED 2,689
3.0%
15 PAIN 2,646
2.9%
16 MALAISE 2,495
2.8%
17 FREQUENT BOWEL MOVEMENTS 2,447
2.7%
18 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION 2,122
2.3%
19 INTENTIONAL PRODUCT USE ISSUE 2,035
2.2%
20 VOMITING 2,016
2.2%
21 DYSPNOEA 1,767
2.0%
22 ASTHENIA 1,731
1.9%
23 DIZZINESS 1,727
1.9%
24 RECTAL HAEMORRHAGE 1,705
1.9%
25 RASH 1,700
1.9%
26 WEIGHT INCREASED 1,684
1.9%
27 INJECTION SITE PAIN 1,591
1.8%
28 PNEUMONIA 1,509
1.7%
29 NASOPHARYNGITIS 1,489
1.6%
30 ABDOMINAL PAIN UPPER 1,331
1.5%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.