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dabigatran etexilate mesylate

Pharmaranks rates Dabigatran Etexilate Mesylate 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Dabigatran Etexilate Mesylate is a direct thrombin inhibitor used to treat Pulmonary Embolism, Venous Thrombosis.

Direct Thrombin Inhibitor · by Breckenridge

Generic of Pradaxa

70/100Limited · 1 source

Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →

Rated against independent regulatory sources·Last updated October 10, 2026·How we rate
Verified againstopenFDANIH DailyMedRxClass

Key facts

Form
Capsule
Strength
Dabigatran Etexilate Mesylate EQ 110MG Base · Dabigatran Etexilate Mesylate EQ 150MG Base · Dabigatran Etexilate Mesylate EQ 75MG Base
Type
Prescription (Rx)
Brand or generic
Generic
Manufacturer
Breckenridge
What the pharmacy pays
~$26.96 for 30 — not your price
FDA application
ANDA207922
Availability
Discontinued (per FDA)

Drug class

May treat (source: NIH RxClass)

Dosage forms

Capsule

The forms currently marketed in the U.S., per the FDA National Drug Code Directory.

Ways to save

Ask for the generic

Same active ingredient, far cheaper. Is there a generic? →

Request a 90-day supply

Bulk fills usually lower the per-dose price vs monthly refills.

Use copay cards

Manufacturer copay cards & patient-assistance programs — especially for brand drugs.

Compare alternatives

A same-class option may cost less. See alternatives →

Frequently asked questions

What does Dabigatran Etexilate Mesylate treat?
Dabigatran Etexilate Mesylate (Dabigatran Etexilate Mesylate) may be used to treat pulmonary embolism, venous thrombosis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
How is Dabigatran Etexilate Mesylate rated?
pharmaranks gives Dabigatran Etexilate Mesylate a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
How much does Dabigatran Etexilate Mesylate cost?
Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $26.96 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
Is there a coupon or discount for Dabigatran Etexilate Mesylate?
pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Dabigatran Etexilate Mesylate. To pay less, Dabigatran Etexilate Mesylate is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
Who makes Dabigatran Etexilate Mesylate?
Dabigatran Etexilate Mesylate is marketed by Breckenridge. You can see Breckenridge's full profile, rating, and other products on pharmaranks.
Is Dabigatran Etexilate Mesylate a brand-name or generic drug?
Dabigatran Etexilate Mesylate is a generic medication; its active ingredient is Dabigatran Etexilate Mesylate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
Is Dabigatran Etexilate Mesylate available over the counter?
No. Dabigatran Etexilate Mesylate is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
What forms does Dabigatran Etexilate Mesylate come in?
Dabigatran Etexilate Mesylate is currently marketed as capsule, per the FDA's National Drug Code Directory.
What class of drug is Dabigatran Etexilate Mesylate?
Dabigatran Etexilate Mesylate is classified as direct thrombin inhibitor, per the FDA's Established Pharmacologic Class.
Is Dabigatran Etexilate Mesylate FDA-registered?
Dabigatran Etexilate Mesylate is on record with the U.S. FDA under application number ANDA207922. You can verify this on its official FDA label.
Has Dabigatran Etexilate Mesylate been recalled by the FDA?
Dabigatran Etexilate Mesylate has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
Is Dabigatran Etexilate Mesylate safe?
There's no single safe-or-not verdict. pharmaranks gives Dabigatran Etexilate Mesylate a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.

Information is sourced from public FDA regulatory data. Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.

What people report to the FDA about Dabigatran Etexilate Mesylate

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,236 reports naming Dabigatran Etexilate Mesylate, and the FDA flagged 93% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

  • cardiac tamponade94 reports
  • haemorrhage71 reports
  • fall68 reports
  • gastrointestinal haemorrhage62 reports
  • rectal haemorrhage47 reports
  • subdural haematoma45 reports
  • acute kidney injury38 reports
  • cardiac failure36 reports

Read these as a signal, not a rate. A report does not mean Dabigatran Etexilate Mesylate caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.

Source: openFDA drug/event (FAERS), retrieved September 25, 2026.

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dabigatran etexilate mesylate

70/100