ALTEPLASE

N/A

Manufactured by Genentech, Inc.

22,483 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ALTEPLASE

ALTEPLASE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Genentech, Inc.. The most commonly reported adverse reactions for ALTEPLASE include NO ADVERSE EVENT, OFF LABEL USE, DEATH, GINGIVAL BLEEDING, CEREBRAL HAEMORRHAGE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ALTEPLASE.

Top Adverse Reactions

NO ADVERSE EVENT2,461 reports
OFF LABEL USE1,820 reports
DEATH1,181 reports
GINGIVAL BLEEDING1,017 reports
CEREBRAL HAEMORRHAGE795 reports
HAEMORRHAGE INTRACRANIAL724 reports
DRUG INEFFECTIVE607 reports
ANGIOEDEMA605 reports
HAEMORRHAGE566 reports
HAEMORRHAGIC TRANSFORMATION STROKE423 reports
PRODUCT STORAGE ERROR374 reports
NAUSEA354 reports
HYPOTENSION340 reports
DYSPNOEA331 reports
VOMITING331 reports
PNEUMONIA277 reports
CHEST PAIN270 reports
HEADACHE250 reports
CEREBROVASCULAR ACCIDENT244 reports
INTERCEPTED MEDICATION ERROR244 reports
PYREXIA240 reports
INTERCEPTED PRODUCT STORAGE ERROR235 reports
PAIN210 reports
CEREBRAL INFARCTION209 reports
NEUROLOGICAL DECOMPENSATION191 reports
PULMONARY EMBOLISM191 reports
RESPIRATORY FAILURE184 reports
ISCHAEMIC STROKE175 reports
INTENTIONAL PRODUCT USE ISSUE171 reports
CARDIAC ARREST169 reports
HAEMATOMA161 reports
FATIGUE160 reports
APLASTIC ANAEMIA150 reports
DRUG INTERACTION150 reports
BRADYCARDIA145 reports
GASTROINTESTINAL HAEMORRHAGE145 reports
SWOLLEN TONGUE144 reports
ANAEMIA135 reports
ASTHENIA134 reports
SEPSIS132 reports
ACUTE KIDNEY INJURY131 reports
BRAIN OEDEMA131 reports
VENTRICULAR TACHYCARDIA130 reports
HYPERTENSION129 reports
EPISTAXIS127 reports
PRODUCT QUALITY ISSUE127 reports
SUBARACHNOID HAEMORRHAGE127 reports
MYOCARDIAL INFARCTION126 reports
VENTRICULAR EXTRASYSTOLES123 reports
CEREBRAL HAEMATOMA122 reports
MOUTH HAEMORRHAGE120 reports
BLOOD PRESSURE INCREASED117 reports
DIARRHOEA117 reports
HAEMOGLOBIN DECREASED116 reports
DIZZINESS115 reports
ATRIAL FIBRILLATION114 reports
COMA113 reports
FEBRILE NEUTROPENIA113 reports
RASH108 reports
DEEP VEIN THROMBOSIS107 reports
HYPERHIDROSIS106 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION104 reports
HYPERSENSITIVITY103 reports
CHEST DISCOMFORT101 reports
MEDICATION ERROR101 reports
BRAIN HERNIATION100 reports
ANAPHYLACTIC REACTION99 reports
THROMBOCYTOPENIA99 reports
SEIZURE98 reports
ABDOMINAL PAIN97 reports
COUGH97 reports
HAEMATURIA96 reports
CONDITION AGGRAVATED91 reports
HAEMORRHAGIC STROKE91 reports
TACHYCARDIA89 reports
PRURITUS88 reports
BLOOD PRESSURE DECREASED87 reports
LIP SWELLING87 reports
TONGUE HAEMORRHAGE86 reports
ANXIETY85 reports
CONFUSIONAL STATE84 reports
HEMIPARESIS84 reports
BACK PAIN82 reports
CARDIAC FAILURE81 reports
CARDIOGENIC SHOCK80 reports
APHASIA79 reports
PAIN IN EXTREMITY79 reports
URTICARIA77 reports
VENTRICULAR FIBRILLATION77 reports
HAEMORRHAGIC INFARCTION76 reports
HYPOXIA75 reports
THROMBOSIS75 reports
ACUTE MYOCARDIAL INFARCTION73 reports
GENERAL PHYSICAL HEALTH DETERIORATION73 reports
RENAL FAILURE73 reports
SEPTIC SHOCK73 reports
CARDIAC FAILURE CONGESTIVE71 reports
ARTHRALGIA70 reports
TONGUE OEDEMA70 reports
OXYGEN SATURATION DECREASED68 reports

Report Outcomes

Out of 14,601 classified reports for ALTEPLASE:

Serious 68.9%Non-Serious 31.1%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male5,746 (52.7%)
Female4,682 (43.0%)
Unknown469 (4.3%)

Reports by Age

Age 75243 reports
Age 67223 reports
Age 59213 reports
Age 65213 reports
Age 74212 reports
Age 63206 reports
Age 60200 reports
Age 72199 reports
Age 76198 reports
Age 70197 reports
Age 61196 reports
Age 71191 reports
Age 68184 reports
Age 69183 reports
Age 78181 reports
Age 64180 reports
Age 55178 reports
Age 66178 reports
Age 73176 reports
Age 77175 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ALTEPLASE?

This profile reflects 22,483 FDA FAERS reports that mention ALTEPLASE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ALTEPLASE?

Frequently reported terms in FAERS include NO ADVERSE EVENT, OFF LABEL USE, DEATH, GINGIVAL BLEEDING, CEREBRAL HAEMORRHAGE, HAEMORRHAGE INTRACRANIAL. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ALTEPLASE?

Labeling and FAERS entries often list Genentech, Inc. in connection with ALTEPLASE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.