Prescription medicine
Lubiprostone Brand names: Amitiza, Amitza
Lubiprostone (Amitza) is a prescription medicine with an FDA approval on record since 2006. FDA's NDC Directory lists it from 10 generic labelers, and pharmacies paid $0.651 per lubiprostone 24 mcg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the lubiprostone FDA label on DailyMed (effective July 28, 2026, Golden State Medical Supply, Inc.); the NDA 21908 record on Drugs@FDA; every lubiprostone label on DailyMed.
Highlights of the record
FDA label of July 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageLubiprostone is a chloride channel activator indicated for the treatment of: chronic idiopathic constipation (CIC) in adults.
Forms and strengths
- 0.008 mg
- 0.024 mg
Gelatin-coated capsule; capsule.
On the market
- Earliest approval on file
- January 31, 2006 Amitiza, Sucampo Pharma Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first November 30, 2021; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 19 of which 10 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- October 25, 2027 Amitiza capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.651 per capsule Lubiprostone 24 mcg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2013 0 Class I among all firms' recalls; latest May 13, 2019; 1 more by firms not listed as its makers
- FAERS reports
- 9,403 through July 30, 2026
What is lubiprostone used for?
From the label: indications and usageLubiprostone is a chloride channel activator indicated for the treatment of: chronic idiopathic constipation (CIC) in adults. ( 1.1 ) opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. ( 1.2 ) Limitations of Use: Effectiveness of lubiprostone in the treatment of OIC in patients taking diphenylheptane opioids (e.g., methadone) has not been established. ( 1.2 , 7.1 ) irritable bowel syndrome with constipation (IBS-C) in women ≥ 18 years old. […]
Conditions named in the indications of lubiprostone's FDA labels, with every medicine labeled for each:
From other lubiprostone labelsConstipation: Constipation in Adults Lubiprostone is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
Irritable bowel syndrome: Syndrome with Constipation Lubiprostone is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in women at least 18 years old.
FDA pharmacologic class: Chloride Channel Activator.
Source: FDA drug label (Lubiprostone), 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
Is there a generic for lubiprostone (Amitza)?
The FDA approved the first generic lubiprostone on November 30, 2021. 6 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists lubiprostone from 10 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 3 patents for Amitiza capsules, the last expiring on October 25, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2006 earliest approval on file
- 2021 first generic approved
- 2027 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for lubiprostone (Amitza)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.651 per Lubiprostone 24 mcg capsule, down 21% from $0.825 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Lubiprostone 8 mcg capsule (generic)
- Amitiza 24 mcg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Lubiprostone 24 mcg capsule | Generic | $0.651 per capsule | $19.52 | -21% |
| Lubiprostone 8 mcg capsule | Generic | $0.565 per capsule | $16.96 | -25% |
| Amitiza 24 mcg capsule | Brand | $6.45 per capsule | $193.47 | +4% |
| Amitiza 8 mcg capsule | Brand | $6.47 per capsule | $194.03 | +0.3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has lubiprostone been recalled?
The FDA's Enforcement Report lists 4 recalls naming lubiprostone since 2013: 0 Class I (the most serious), 3 Class II, 1 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of lubiprostone and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 13, 2019 | Class II | MALLINCKRODT PHARMACEUTICALS | Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. … |
| November 6, 2018 | Class III | Takeda Development Center Americas, Inc. | Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; LUBIPROSTONE Capsule, 24 mcg may be potentially mislabeled as ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD21790_43, EXP … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the lubiprostone label say about other medicines?
The lubiprostone label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Methadone | drug interactions | DRUG INTERACTIONS 7.1 Methadone Diphenylheptane opioids (e.g., methadone) have been shown in nonclinical studies to dose-dependently reduce the activation of ClC-2 by lubiprostone in the gastrointestinal tract. |
Source: FDA drug label (Lubiprostone), 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 for lubiprostone?
The FDA Adverse Event Reporting System holds 9,403 reports that list lubiprostone among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as lubiprostone?
17 other medicines are given the same way (oral) and in the same FDA class as lubiprostone or labeled mainly for the same use (constipation), the same class first. Constipation lists all 20 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Docusate | Constipation | none listed | $0.0276 per unit 100 mg softgel | No current entry |
| Sennosides | Constipation | none listed | $0.0258 per tablet 8.6 mg tablet | No current entry |
| Polyethylene glycol 3350 | Constipation | 73 labelers | $0.0286 per gram 3350 powd | No current entry |
| Bisacodyl | Constipation | none listed | $0.0441 per tablet 5 mg tablet | No current entry |
| Magnesium hydroxide | Constipation | none listed | $0.0095 per mL Milk of magnesia suspension | No current entry |
| Magnesium citrate | Constipation | none listed | $0.0066 per mL Magnesium citrate solution | No current entry |
| Prucalopride | Constipation | 18 labelers | $0.639 per tablet 1 mg tablet | No current entry |
| Psyllium husk | Constipation | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as lubiprostone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does lubiprostone compare with medicines for the same use?
1 side-by-side page set lubiprostone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to lubiprostone
- 17 medicines for the same use
- Lubiprostone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other