Drug Safety Information for LINZESS (Linaclotide)

Safety-related Labeling Changes for LINZESS (LINACLOTIDE) Rx Drug: FDA Link

Required post-approval safety study:

A safety and efficacy study in pediatric patients with irritable bowel syndrome with constipation ages seven years up to 17 years treated with Linzess (linaclotide). Due Date: 2023-12-31

Required post-approval safety study:

Conduct a safety and efficacy study in pediatric patients with chronic idiopathic constipation ages 6 to 17 years treated with Linzess (linaclotide). Due Date: 2023-12-31

Original FDA Drug Approval Date for LINZESS: 2012-08-30

Adverse Drug Reactions for LINZESS* (Linaclotide)

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 LINZESS
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Diarrhoea	1255
2	Drug ineffective	655
3	Abdominal pain	315
4	Abdominal distension	292
5	Off label use	237
6	Flatulence	203
7	Nausea	195
8	Abdominal pain upper	145
9	Dizziness	126
10	Headache	119
11	Constipation	108
12	Fatigue	71
13	Rash	63
14	Asthenia	61
15	Vomiting	58
16	Muscle spasms	56
17	Abdominal discomfort	52
18	Weight increased	51
19	Dyspnoea	50
20	Weight decreased	46

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

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

	Reason	# of FDA Reports
1	Constipation	2679
2	Irritable bowel syndrome	1215
3	Product used for unknown indication	552
4	Abdominal pain	45
5	Gastrointestinal disorder	38
6	Gastrointestinal motility disorder	36
7	Impaired gastric emptying	24
8	Crohn's disease	23
9	Gastrointestinal hypomotility	21
10	Bowel movement irregularity	20

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

Types of Adverse Events for LINZESS

Total Reports Filed with FDA: 7391

Number of FDA Adverse Event Reports by Patient Age for LINZESS

Total Reports Filed with FDA: 7391*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Linaclotide (Linzess)

Charts are based on 7391 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.

Historical 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.