linaclotide

Score breakdown (78/100)

Safety: 95

• 2,368 FDA reports naming it as the suspect drug per million Medicare fills, 0.9x the median drug on this site
• Death share in reports is near or below the FAERS average (0.5x)
• Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)

Evidence: 51

• 41 randomized trials and 14 systematic reviews/meta-analyses indexed in PubMed
• No Cochrane review found (-5)

Regulatory history: 96

• No recalls on record since 2016
• 2 label changes approved since 2021 (-4)

Money & lawsuits: 70

• Pharma paid doctors $1,771,865 tied to this drug last year (-30)
• Not named in any pending federal MDL

Options: 70

• Generic versions approved (3 applications)
• No same-class alternatives found: little leverage to switch (-30)

What the FDA label says

Approved uses

Not available.

Contraindications

None listed.

Source: FDA SPL label, effective .

Side-effect reports sent to the FDA

These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.

Problems reported most often

Reports per year

2,368 reports blaming this drug for every million Medicare prescriptions filled, which is 0.9× the typical drug on this site. (5,935 reports in 2024–2026, against 2,506,531 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)

Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.

Recalls and regulatory record

Evidence base

Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.

Money and lawsuits

In 2024, drug companies reported $1,771,865 in payments to US physicians and hospitals tied to this drug across 67,810 transactions (Linzess $1,771,865).

No pending federal MDL names this drug or its brands.

Not named in any federal pharmaceutical settlement of $100M or more on record.

Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.

Who takes it and what it costs

Same-class alternatives

No same-class alternatives found in RxClass.

Questions to ask your prescriber

1. The most-reported problems in FDA's adverse event data are diarrhoea, constipation. How would we recognize and handle those?
2. Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
3. The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?
4. What result are we expecting, by when, and what is the plan if it does not happen?
5. If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)