The most commonly reported side effects of alteplase include no adverse event, off label use, and gingival bleeding, based on 14,748 FDA adverse event reports from 2004 to 2025. 3.7% of reports found the drug to be ineffective.
Percentages show how often each reaction appears relative to total reports for alteplase.
These are voluntary reports and do not establish that alteplase caused these reactions.
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Other drugs that appear in adverse event reports alongside alteplase. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.
Also suspected
Taken alongside
Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.
32.4% of alteplase adverse event reports involve female patients and 39.2% involve male patients. The largest age group is elderly at 48%. These figures reflect who reports side effects, not underlying risk.
Sex
Age group
Conditions and purposes for which patients were taking alteplase when the adverse event was reported.
Showing 15 of 738 indications
Alteplase is sold under the brand name Cathflo Activase.
An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.
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