Alteplase

Common brands: Activase, Cathflo Activase, Pain Relief, Medline, Tylenol Extra Strength

Top reporter: Genentech, Inc.

Nonsteroidal Anti-inflammatory Drug [EPC]Osmotic Laxative [EPC]Platelet Aggregation Inhibitor [EPC]Corticosteroid [EPC]Benzodiazepine [EPC]
14,763
Total Reports
8,006
Serious Reports
3,206
Death Reports
30
Reported Reactions
Death Report Ratio: High (21.72%)

Patient Demographics

Male
5,820
Female
4,727

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Alteplase.

# Reaction Reports % of Total
1 NO ADVERSE EVENT 2,489
16.2%
2 OFF LABEL USE 1,846
12.0%
3 DEATH 1,185
7.7%
4 GINGIVAL BLEEDING 1,020
6.6%
5 CEREBRAL HAEMORRHAGE 803
5.2%
6 HAEMORRHAGE INTRACRANIAL 726
4.7%
7 DRUG INEFFECTIVE 626
4.1%
8 ANGIOEDEMA 620
4.0%
9 HAEMORRHAGE 570
3.7%
10 HAEMORRHAGIC TRANSFORMATION STROKE 430
2.8%
11 PRODUCT STORAGE ERROR 381
2.5%
12 NAUSEA 363
2.4%
13 HYPOTENSION 343
2.2%
14 DYSPNOEA 339
2.2%
15 VOMITING 335
2.2%
16 PNEUMONIA 281
1.8%
17 CHEST PAIN 270
1.8%
18 HEADACHE 251
1.6%
19 CEREBROVASCULAR ACCIDENT 246
1.6%
20 INTERCEPTED PRODUCT STORAGE ERROR 245
1.6%
21 INTERCEPTED MEDICATION ERROR 244
1.6%
22 PYREXIA 242
1.6%
23 CEREBRAL INFARCTION 212
1.4%
24 PAIN 212
1.4%
25 NEUROLOGICAL DECOMPENSATION 195
1.3%
26 RESPIRATORY FAILURE 193
1.3%
27 PULMONARY EMBOLISM 192
1.2%
28 ISCHAEMIC STROKE 180
1.2%
29 CARDIAC ARREST 172
1.1%
30 INTENTIONAL PRODUCT USE ISSUE 171
1.1%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.