What the label lists and what reports show
Lubiprostone side effects
Lubiprostone's FDA label: “Most common adverse reactions (> 4%) are: CIC: nausea, diarrhea, headache, abdominal pain, abdominal distension, and flatulence.” FAERS holds 9,403 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (793 reports).
- Generic listed
Check it at the source: the lubiprostone FDA label on DailyMed (effective July 28, 2026, Golden State Medical Supply, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (> 4%) are: CIC: nausea, diarrhea, headache, abdominal pain, abdominal distension, and flatulence.
Table 2. Adverse Reactions Reported in at least 1% of patients treated with Lubiprostone and greater than placebo in Clinical Trials of Adults with CIC
| System/Adverse Reaction | Placebo N = 316 % | Lubiprostone 24 mcg Twice Daily N = 1113 % |
|---|---|---|
| Nausea | 3 | 29 |
| Diarrhea | 1 | 12 |
| Headache | 5 | 11 |
| Abdominal pain | 3 | 8 |
| Abdominal distension | 2 | 6 |
| Flatulence | 2 | 6 |
| Vomiting | 0 | 3 |
| Loose stools | 0 | 3 |
| Edema | <1 | 3 |
| Abdominal discomfort This term combines "abdominal tenderness," "abdominal rigidity,"… | 1 | 3 |
| Dizziness | 1 | 3 |
| Chest discomfort/pain | 0 | 2 |
| Dyspnea | 0 | 2 |
| Dyspepsia | <1 | 2 |
| Fatigue | 1 | 2 |
| Dry mouth | <1 | 1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are described below and elsewhere in labeling: Nausea [see Warnings and Precautions (5.1) ] Diarrhea [see Warnings and Precautions (5.2) ] Syncope and Hypotension [see Warnings and Precautions (5.3) ] Dyspnea [see Warnings and Precautions (5.4) ] Most common adverse reactions (> 4%) are: CIC: nausea, diarrhea, headache, abdominal pain, abdominal distension, and flatulence. ( 6.1 ) OIC: nausea and diarrhea. ( 6.1 ) IBS-C: nausea, diarrhea, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. During clinical development of lubiprostone for CIC, OIC, and IBS-C, 1648 patients were treated with lubiprostone for 6 months and 710 patients were treated for 1 year (not mutually exclusive). …
Source: FDA drug label, NDA021908 (Sucampo Pharma Llc), as published by Golden State Medical Supply, Inc., effective July 28, 2026 (SPL set f4d506e0-1322-4fc4-e053-2995a90ac880), via openFDA; the full label on DailyMed
What do FAERS reports show?
9,403 reports list lubiprostone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 961 are coded as a death and 3,087 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Lubiprostone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions