Alteplase: uses, dosing, side effects & brands
Alteplase is a medicine sold in the U.S. under 2 brand and generic names, for arterial occlusive diseases, intracranial embolism and thrombosis and myocardial infarction. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats (across its forms)
- Arterial Occlusive Diseases, Intracranial Embolism and Thrombosis and Myocardial Infarction
- Available as
- Kit · Injectable
- Sold as
- 2 products — Activase and Cathflo Activase
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How Activase is dosed
From the FDA label for Activase (application BLA103172). Other alteplase products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Cathflo ® Activase ® (Alteplase) is for instillation into the dysfunctional catheter at a concentration of 1 mg/mL. • Patients weighing ≥30 kg: 2 mg in 2 mL • Patients weighing <30 kg: 110% of the internal lumen volume of the catheter, not to exceed 2 mg in 2 mL If catheter function is not restored at 120 minutes after 1 dose of Cathflo Activase, a second dose may be instilled (see Instructions for Administration ). There is no efficacy or safety information on dosing in excess of 2 mg per dose for this indication. Studies have not been performed with administration of total doses greater than 4 mg (two 2‑mg doses). Instructions for Administration Preparation of Solution Reconstitute Cathflo Activase to a final concentration of 1 mg/mL: Aseptically withdraw 2.2 mL of Sterile Water for Injection, USP (diluent is not provided). Do not use Bacteriostatic Water for Injection. Inject the 2.2 mL of Sterile Water for Injection, USP, into the Cathflo Activase vial, directing the diluent stream into the powder. Slight foaming is not unusual; let the vial stand undisturbed to allow large bubbles to dissipate. Mix by gently swirling until the contents are completely dissolved. Complete dissolution should occur within 3 minutes. DO NOT SHAKE. The reconstituted preparation results in a colorless to pale yellow transparent solution containing 1 mg/mL Cathflo Activase at a pH of…
Everything below is the FDA label for Activase (kit). Alteplase is also sold as injectable, and those are different medicines to take — follow the label for the one you were prescribed.
Activase side effects
The following adverse reactions are discussed in greater detail in Section PRECAUTIONS of the label: Bleeding Hypersensitivity In the clinical trials, the most serious adverse events reported after treatment were sepsis (see PRECAUTIONS, Infections ), gastrointestinal bleeding, and venous thrombosis. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Trials 1 and 2 The data described for Trials 1 and 2 reflect exposure to Cathflo Activase in 1122 patients, of whom 880 received a single dose and 242 received two sequential doses of Cathflo Activase. In the Cathflo Activase Trials 1 and 2, only limited, focused types of serious adverse events were recorded, including death, major hemorrhage, intracranial hemorrhage, pulmonary or arterial emboli, and other serious adverse events not thought to be attributed to underlying disease or concurrent illness. Major hemorrhage was defined as severe blood loss ( > 5 mL/kg), blood loss requiring transfusion, or blood loss causing hypotension. Non‑serious adverse events and serious events thought to be due to underlying disease or concurrent illness were not recorded. Patients were observed for serious adverse events until catheter…
Who shouldn’t take Activase
Cathflo Activase should not be administered to patients with known hypersensitivity to Alteplase or any component of the formulation (see DESCRIPTION ).
Activase drug interactions
The interaction of Cathflo Activase with other drugs has not been formally studied. Concomitant use of drugs affecting coagulation and/or platelet function has not been studied.
Every alteplase product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Kit | No data | — | View → | |
| 2 | 70/100 | Prescription | Injectable | No data | — | View → |
Alteplase recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Alteplase and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for alteplase: levels in milk, effects in breastfed infants, and the drugs it would consider insteadTissue plasminogen activator (tPA), which is identical to alteplase, is a normal component of human colostrum and breastmilk. Levels in milk are highest in colostrum and decrease rapidly during the first week, followed by a slower decrease over time. Because alteplase is a large protein molecule with a molecular weight of about 59,000 Da, absorption is unlikely because it is probably partially destroyed in the infant's gastrointestinal tract and poorly absorbed orally. No information is available on the clinical use of alteplase during breastfeeding. Until more data become available, alteplase should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.
National Institute of Child Health and Human Development, record revised December 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about alteplase
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 8,595 reports naming alteplase, and the FDA flagged 80% 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:
- gingival bleeding1,004 reports
- cerebral haemorrhage643 reports
- haemorrhage intracranial457 reports
- angioedema335 reports
- haemorrhagic transformation stroke319 reports
- haemorrhage307 reports
- pneumonia225 reports
- vomiting208 reports
Read these as a signal, not a rate. A report does not mean alteplase 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 section above.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
Related calculators
Frequently asked questions
What is Activase?
Activase (Alteplase) is a medication used to treat Arterial Occlusive Diseases, Intracranial Embolism and Thrombosis, Myocardial Infarction, Pulmonary Embolism.
Can you take alteplase with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run alteplase against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is alteplase sold under?
We track 2 alteplase-containing products in the U.S.: Activase and Cathflo Activase. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does alteplase come in?
Across the brands we track, alteplase is currently marketed as kit and injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic alteplase?
We do not currently list a generic-labelled alteplase product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Has alteplase been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions alteplase. The most recent: Cathflo activase (ALTEPLASE) (May 20, 2024). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Alteplase: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/alteplase
- MLA
- “Alteplase: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/alteplase.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for alteplase on DailyMed (NIH) ↗.