FDA Adverse Events Reports (FAERS) Summary for AMITIZA

These tables and charts are based on 8,520 total reports for AMITIZA (LUBIPROSTONE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through July 30, 2026.

This FAERS total includes 8,017 pharmaceutical company-submitted and non-U.S. FAERS reports and 503 U.S. consumer or healthcare provider-submitted MedWatch reports. Adverse events listed on this page represent serious and sometimes rare adverse events reported to pharmaceutical companies, and often do not represent typical side effects for the medication. Find common side effects in the most recent official drug label.

For a separate summary of the 503 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch AMITIZA summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with AMITIZA (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	NAUSEA	717
2	SHORTNESS OF BREATH	607
3	DIARRHEA	576
4	CONSTIPATION	518
5	DRUG INEFFECTIVE	512
6	FATIGUE	480
7	PAIN	454
8	HEADACHE	450
9	DIZZINESS	400
10	FALL	370
11	VOMITING	361
12	CHRONIC KIDNEY DISEASE	330
13	MALAISE	299
14	OFF LABEL USE	281
15	FEVER	280
16	LACK OF STRENGTH AND ENERGY (ASTHENIA)	265
17	ANXIETY	258
18	KIDNEY FAILURE	256
19	PNEUMONIA	254
20	DECREASED APPETITE	246
21	DEPRESSION	244
22	ABDOMINAL PAIN	242
23	WEIGHT DECREASED	241
24	ACUTE KIDNEY INJURY	232
25	INSOMNIA	218
26	DEATH	212
27	JOINT PAIN	202
28	CHEST PAIN	200
29	FEELING ABNORMAL	199
30	CHEST DISCOMFORT	198
31	ABDOMINAL PAIN UPPER	190
32	RASH	190
33	ABDOMINAL DISTENSION	188
34	GAIT DISTURBANCE	188
35	CONDITION AGGRAVATED	182
36	PAIN IN EXTREMITY	182
37	BACK PAIN	181
38	URINARY TRACT INFECTION	179
39	DROWSINESS	178
40	COUGH	174
41	DEHYDRATION	172
42	TREMOR	169
43	ANEMIA	167
44	ITCHING	167
45	MUSCLE SPASMS	158
46	WEIGHT INCREASED	151
47	HIGH BLOOD PRESSURE	139
48	LOSS OF CONSCIOUSNESS	129
49	SWELLING OF LIMBS	126
50	ABDOMINAL DISCOMFORT	122
51	NUMBNESS	121
52	GASTROOESOPHAGEAL REFLUX DISEASE	119
53	EXCESS SWEATING	119
54	MEMORY IMPAIRMENT	119
55	KIDNEY IMPAIRMENT	119
56	LOWER LIMBS SWELLING	118
57	BALANCE DISORDER	109
58	DRUG DOSE OMISSION	107
59	MUSCULAR WEAKNESS	105
60	BLOOD PRESSURE DECREASED	103
61	BRONCHITIS	102
62	PINS AND NEEDLES	102
63	FAINTING	101
64	BLOOD PRESSURE INCREASED	100
65	KIDNEY FAILURE	100
66	INDIGESTION	99
67	DIFFICULTY SWALLOWING	99
68	PALPITATIONS	99
69	MIGRAINE	98
70	SEPSIS	98
71	HAIR LOSS	97
72	SINUSITIS	97
73	COMMON COLD	96
74	PLATELET COUNT DECREASED	95
75	INJECTION SITE PAIN	94
76	BRUISE	93
77	LOW BLOOD PRESSURE	91
78	CONFUSIONAL STATE	90
79	PRODUCT USE ISSUE	90
80	ASTHMA	89
81	BLOOD GLUCOSE INCREASED	87
82	CHILLS	87
83	FLATULENCE	85
84	HYPOKALAEMIA	83
85	MUSCLE PAIN	83
86	PRODUCT DOSE OMISSION ISSUE	83
87	WHITE BLOOD CELL COUNT DECREASED	83
88	HALLUCINATION	82
89	LIVER FUNCTION ABNORMAL	81
90	HYPERSENSITIVITY	81
91	INCORRECT DOSE ADMINISTERED	81
92	DRUG HYPERSENSITIVITY	80
93	HEART RATE INCREASED	79
94	INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION	79
95	DRY MOUTH	78
96	INFECTION	76
97	INTERSTITIAL LUNG DISEASE	76
98	SKIN REDNESS	73
99	MULTIPLE SCLEROSIS RELAPSE	73
100	NEUROPATHY PERIPHERAL	73

Latest Known Outcomes for Reactions Reported for AMITIZA

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	4322
2	Patient recovered	2326
3	Patient has not recovered/symtoms have not resolved	2231
4	Patient is recovering/symptoms resolving	1206
5	Patient died	752
6	Patient has recovered but has consequent health issues	81

Yearly FDA Adverse Event Reports (Table)

Year	Number of Reports
2006	19
2007	103
2008	161
2009	179
2010	213
2011	207
2012	301
2013	369
2014	400
2015	587
2016	861
2017	748
2018	879
2019	841
2020	688
2021	540
2022	360
2023	316
2024	304
2025	298
2026	146

Reports by Patient Age Group (Table)

Age Group	Number of Reports
0-10	105
11-20	86
21-30	205
31-40	347
41-50	715
51-60	1004
61-70	1190
71-80	1081
81-90	618
91+	102

Based on 5453 reports that included a patient age.

AMITIZA Total Reports

Male	Female	Unknown	Total
2316	5588	616	8,520

Top Countries Reporting

	Country	Number of Reports
1	United States	5160
2	Japan	2164
3	Brazil	37
4	Switzerland	5
5	United Kingdom	3
6	Canada	2
7	Italy	2
8	Germany	1
9	Denmark	1
10	France	1

Outcomes for Reports

Serious: 5661
Not Serious: 2859
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Product used for unknown indication
Constipation
Irritable bowel syndrome
Gastrointestinal disorder

Top Companies Reporting

MALLINCKRODT

Safety-Related FDA Updates

FDA Approval Date: 2006-01-31

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

Have experience (good or bad) with AMITIZA? Rate AMITIZA at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

Events listed on this page represent serious and often rare adverse events reported to pharmaceutical companies, and do not represent typical side effects for the medication. Find common side effects on the most recent official drug label This report, created by AskaPatient.com, is derived from the cases for AMITIZA reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through July 30, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.