Prescription medication · Chloride Channel Activator
lubiprostone
Also sold as Amitiza. This medicine treats chronic idiopathic constipation (CIC) in adults.
Data updated 2026-05-15
- 9,102
- FDA reportsLightly reported
- 1
- InteractionFew interactions
- 88% less
- Generic vs brandHuge savings
- $5.94
- Brand price (NADAC)
What the data shows
lubiprostone (Amitiza) is a prescription Chloride Channel Activator, reported less often than most tracked drugs (9,102 FDA reports), whose generic runs roughly half the brand price or less (88% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
lubiprostone (Amitiza) is a prescription Chloride Channel Activator. This medicine treats chronic idiopathic constipation (CIC) in adults.
Lubiprostone is a medicine that helps treat constipation. It works by increasing fluid in your intestines, which makes it easier to pass stool.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$5.94/unit
Generic Price
$0.69/unit
Generic Savings
88%
Generic Available
Yes (3 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine treats chronic idiopathic constipation (CIC) in adults.
Common side effects
Nausea, Diarrhea, Headache
Key warnings
You should not take this medicine if you have a known or suspected blockage in your intestines.
The sections below are summarized in plain English from lubiprostone's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Lubiprostone is a chloride channel activator. It works by increasing the amount of fluid in your intestines. This helps to soften your stool and make it easier to have a bowel movement.
Side Effects (from patient reports)
Based on 9,102 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for lubiprostone, by number of reports
- Nausea
Nausea
765 reports
- Dyspnoea
Dyspnoea
621 reports
- Diarrhoea
Diarrhoea
581 reports
- Constipation
Constipation
558 reports
- Fatigue
Fatigue
519 reports
- Headache
Headache
483 reports
- Pain
Pain
483 reports
- Dizziness
Dizziness
440 reports
- Fall
Fall
398 reports
- Vomiting
Vomiting
381 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for lubiprostone each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where lubiprostone sits
lubiprostone has more FDA adverse-event reports than 37% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is lubiprostone; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 9,102 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2006–2025.
Total Reports
9,102
Reports Mentioning Death
927
10.2% of reports — not proof of cause
Hospitalization Reports
3,000
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | NAUSEA | 765 |
| 2 | DYSPNOEA | 621 |
| 3 | DIARRHOEA | 581 |
| 4 | CONSTIPATION | 558 |
| 6 | FATIGUE | 519 |
| 7 | HEADACHE | 483 |
| 8 | PAIN | 483 |
| 9 | DIZZINESS | 440 |
| 10 | FALL | 398 |
| 11 | VOMITING | 381 |
| 12 | CHRONIC KIDNEY DISEASE | 334 |
| 14 | MALAISE | 312 |
| 15 | PYREXIA | 294 |
| 16 | ASTHENIA | 284 |
| 17 | PNEUMONIA | 277 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
You should not take this medicine if you have a known or suspected blockage in your intestines. This medicine can cause nausea, diarrhea, fainting, low blood pressure, and shortness of breath. If you have severe diarrhea while taking this medicine, stop taking it and call your doctor.
Known Drug Interactions
7 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. The effectiveness of lubiprostone in the treatment of OIC in patients taking diphenylhepatane opioids (e.g., methadone) has not been established [see Indications and Usage (1.2) ] .
Mechanism: Methadone can block the way this medicine works in your gut, which may make it less effective at treating constipation.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
What should I do if I feel nauseous after taking this medicine?
Can this medicine cause diarrhea?
Will this medicine interact with other medicines I am taking?
How long does it take for this medicine to work?
Can I drive or operate machinery while taking this medicine?
What if I have liver problems?
Is it okay to take this medication long-term?
What do the capsules look like?
What if I have a bowel obstruction?
Can this medicine cause shortness of breath?
What are the common side effects of lubiprostone?
Does lubiprostone interact with other medications?
What drug class is lubiprostone?
Is there a generic version of lubiprostone?
What pregnancy or breastfeeding source fields are listed for lubiprostone?
Related Medications in Chloride Channel Activator
Other drugs grouped near lubiprostone - same-class peers and common alternatives.
alosetron
Lotronex
Alosetron (Lotronex) is a medicine for women with severe diarrhea-predominant irritable bowel syndrome (IBS).
Compare with lubiprostone →
aprepitant
Emend
Aprepitant (Emend) is a medicine that helps prevent nausea and vomiting.
Compare with lubiprostone →
bisacodyl
Dulcolax
Bisacodyl is a medicine that helps you have a bowel movement.
Compare with lubiprostone →
bismuth subsalicylate
Pepto-Bismol
Bismuth subsalicylate (Pepto-Bismol) is a medicine that can treat diarrhea and upset stomach.
Compare with lubiprostone →
cimetidine
Tagamet
Cimetidine (Tagamet) reduces stomach acid.
Compare with lubiprostone →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for lubiprostone: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 9,102.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 10.18%.
- sertraline Δ 0.00 pts · 112,198 reports · Selective Serotonin Reuptake Inhibitor (SSRI) 10.19%death share
- ciprofloxacin Δ 0.00 pts · 89,398 reports · Fluoroquinolone Antibiotic 10.18%death share
- trazodone Δ 0.01 pts · 15,113 reports · Serotonin Antagonist and Reuptake Inhibitor (SARI) 10.18%death share
- pioglitazone Δ 0.08 pts · 42,504 reports · Thiazolidinedione 10.11%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for lubiprostone
The FDA label for lubiprostone (sold under brand names such as Amitiza) classifies it as a prescription-only medication in the Chloride Channel Activator class. This medicine treats chronic idiopathic constipation (CIC) in adults. Official labeling lists 6 commonly reported side effects, including Nausea, Diarrhea, Headache.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 9,102 voluntary reports. The database also lists 1 documented drug interaction derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.69 versus $5.94 for the brand - a 88% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: September 11, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages