Drug Safety Information for LIALDA (Mesalamine)

Safety-related Labeling Changes for ROWASA (MESALAMINE) Rx Drug: FDA Link

Safety-related Labeling Changes for ASACOL (MESALAMINE) Rx Drug: FDA Link

Safety-related Labeling Changes for PENTASA (MESALAMINE) Rx Drug: FDA Link

Safety-related Labeling Changes for CANASA (MESALAMINE) Rx Drug: FDA Link

Safety-related Labeling Changes for ASACOL HD (MESALAMINE) Rx Drug: FDA Link

Safety-related Labeling Changes for LIALDA ( MESALAMINE) Rx Drug: FDA Link

Safety-related Labeling Changes for APRISO (MESALAMINE) Rx Drug: FDA Link

Safety-related Labeling Changes for DELZICOL (MESALAMINE) Rx Drug: FDA Link

Adverse Drug Reactions for LIALDA* (Mesalamine)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with LIALDA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Injection site pain1867
2Diarrhoea*1589
3Crohn's disease1588
4Drug ineffective1460
5Nausea1297
6Fatigue1290
7Pyrexia1152
8Abdominal pain1124
9Headache*1116
10Arthralgia*964
11Pain*921
12Vomiting856
13Colitis ulcerative843
14Dyspnoea743
15Rash681
16Injection site haematoma631
17Injection site erythema630
18Dizziness626
19Asthenia625
20Weight decreased598

* This side effect also appears in "Top 10 Side Effects of LIALDA " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking LIALDA
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Crohn's disease*22510
2Product used for unknown indication18742
3Colitis ulcerative*13358
4Colitis*2089
5Inflammatory bowel disease*437
6Gastrointestinal disorder217
7Inflammation213
8Gastric disorder163
9Irritable bowel syndrome*162
10Colitis microscopic*152

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for LIALDA

Total Reports Filed with FDA: 90803


Number of FDA Adverse Event Reports by Patient Age for LIALDA

Total Reports Filed with FDA: 90803*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Mesalamine (Mesasal, Claversal, Sf rowasa, Pentasa, Canasa, Asacol, 5-aminosalicylate, Fiv-asa, Asacol hd, Salofalk, Lixacol, Fivasa, Apriso, Asacolon, Sfrowasa, Mesalamine, Rowasa, Delzicol, Lialda)

Charts are based on 90803 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and LIALDA Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

Visit   DrugInformer.com more on LIALDA's side effects.