Drug Safety Information for AMITIZA (Lubiprostone)

Safety-related Labeling Changes for AMITIZA (LUBIPROSTONE) Rx Drug: FDA Link

Adverse Drug Reactions for AMITIZA* (Lubiprostone)

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 AMITIZA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea*412
2Nausea*310
3Diarrhoea*181
4Constipation*173
5Drug ineffective164
6Pain162
7Chest discomfort160
8Fatigue149
9Dizziness*146
10Headache*146
11Vomiting134
12Chest pain123
13Abdominal pain108
14Anxiety107
15Weight decreased98
16Asthenia97
17Fall84
18Malaise79
19Depression78
20Back pain76

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

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

Reason # of FDA Reports
1Constipation*3239
2Product used for unknown indication946
3Irritable bowel syndrome*907
4Gastrointestinal disorder114
5Gastric disorder46
6Bowel movement irregularity41
7Flatulence40
8Functional gastrointestinal disorder27
9Laxative supportive care25
10Crohn's disease24

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


Types of Adverse Events for AMITIZA

Total Reports Filed with FDA: 12790


Number of FDA Adverse Event Reports by Patient Age for AMITIZA

Total Reports Filed with FDA: 12790*


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

Charts are based on 12790 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 AMITIZA Reviews and Review Summary .

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.