Dabigatran Etexilate

Common brands: Pradaxa, Lasix, Ecotrin, Aspirin 325, Aspirin 81

Top reporter: Boehringer Ingelheim Pharmaceuticals, Inc.

Loop Diuretic [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Platelet Aggregation Inhibitor [EPC]HMG-CoA Reductase Inhibitor [EPC]beta-Adrenergic Blocker [EPC]
76,960
Total Reports
15,338
Serious Reports
11,367
Death Reports
30
Reported Reactions
Death Report Ratio: High (14.77%)

Patient Demographics

Male
36,156
Female
33,090

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Dabigatran Etexilate.

# Reaction Reports % of Total
1 GASTROINTESTINAL HAEMORRHAGE 8,263
13.2%
2 CEREBROVASCULAR ACCIDENT 4,068
6.5%
3 FALL 3,231
5.2%
4 HAEMORRHAGE 3,199
5.1%
5 ANAEMIA 2,852
4.6%
6 DYSPNOEA 2,299
3.7%
7 ISCHAEMIC STROKE 2,285
3.7%
8 DIZZINESS 2,221
3.5%
9 DEATH 2,207
3.5%
10 RECTAL HAEMORRHAGE 2,091
3.3%
11 ATRIAL FIBRILLATION 2,019
3.2%
12 ASTHENIA 1,788
2.9%
13 DIARRHOEA 1,787
2.9%
14 NAUSEA 1,672
2.7%
15 FATIGUE 1,633
2.6%
16 DYSPEPSIA 1,612
2.6%
17 DRUG INTERACTION 1,588
2.5%
18 HEADACHE 1,532
2.4%
19 OFF LABEL USE 1,514
2.4%
20 MELAENA 1,429
2.3%
21 CEREBRAL HAEMORRHAGE 1,428
2.3%
22 DRUG INEFFECTIVE 1,410
2.3%
23 HYPOTENSION 1,358
2.2%
24 COAGULOPATHY 1,357
2.2%
25 EPISTAXIS 1,342
2.1%
26 HAEMATURIA 1,321
2.1%
27 UPPER GASTROINTESTINAL HAEMORRHAGE 1,297
2.1%
28 CONTUSION 1,272
2.0%
29 HAEMORRHAGIC ANAEMIA 1,257
2.0%
30 PNEUMONIA 1,237
2.0%

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.