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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

Does ALTEPLASE Cause Product quality issue? 132 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 132 reports of Product quality issue have been filed in association with ALTEPLASE (Activase). This represents 1.0% of all adverse event reports for ALTEPLASE.

132
Reports of Product quality issue with ALTEPLASE
1.0%
of all ALTEPLASE reports
27
Deaths
20
Hospitalizations

How Dangerous Is Product quality issue From ALTEPLASE?

Of the 132 reports, 27 (20.5%) resulted in death, 20 (15.2%) required hospitalization, and 12 (9.1%) were considered life-threatening.

Is Product quality issue Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for ALTEPLASE. However, 132 reports have been filed with the FAERS database.

What Other Side Effects Does ALTEPLASE Cause?

No adverse event (2,456) Off label use (1,752) Gingival bleeding (1,018) Cerebral haemorrhage (819) Death (818) Haemorrhage intracranial (615) Angioedema (603) Haemorrhage (536) Drug ineffective (524) Haemorrhagic transformation stroke (496)

What Other Drugs Cause Product quality issue?

ETONOGESTREL (4,651) ALBUTEROL (4,466) TIOTROPIUM (3,821) MOMETASONE FUROATE (3,406) LIDOCAINE (3,126) FLUTICASONE\SALMETEROL (2,986) FORMOTEROL\MOMETASONE FUROATE (2,458) FENTANYL (2,450) NICOTINE (1,987) EXENATIDE (1,839)

Which ALTEPLASE Alternatives Have Lower Product quality issue Risk?

ALTEPLASE vs ALTERNARIA ALTERNATA ALTEPLASE vs ALTHIAZIDE ALTEPLASE vs ALTHIAZIDE\SPIRONOLACTONE ALTEPLASE vs ALUMINUM ALTEPLASE vs ALUMINUM HYDROXIDE

Related Pages

ALTEPLASE Full Profile All Product quality issue Reports All Drugs Causing Product quality issue ALTEPLASE Demographics