Amlodipine Besylate / Valsartan

Common brands: Exforge, Ecotrin, Aspirin 325, Aspirin 81, Aspirina Caplets

Top reporter: Novartis Pharmaceuticals Corporation

Angiotensin 2 Receptor Blocker [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Platelet Aggregation Inhibitor [EPC]Proton Pump Inhibitor [EPC]beta-Adrenergic Blocker [EPC]
10,929
Total Reports
2,695
Serious Reports
1,258
Death Reports
30
Reported Reactions
Death Report Ratio: High (11.51%)

Patient Demographics

Male
4,887
Female
5,701

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Amlodipine Besylate / Valsartan.

# Reaction Reports % of Total
1 BLOOD PRESSURE INCREASED 658
6.5%
2 HYPERTENSION 583
5.7%
3 DRUG INEFFECTIVE 542
5.3%
4 DIZZINESS 489
4.8%
5 MALAISE 468
4.6%
6 DEATH 467
4.6%
7 FATIGUE 442
4.4%
8 FALL 429
4.2%
9 HEADACHE 396
3.9%
10 DYSPNOEA 363
3.6%
11 DIABETES MELLITUS 352
3.5%
12 OEDEMA PERIPHERAL 351
3.5%
13 CEREBROVASCULAR ACCIDENT 342
3.4%
14 DIARRHOEA 338
3.3%
15 NAUSEA 319
3.1%
16 ASTHENIA 295
2.9%
17 PAIN 295
2.9%
18 HYPOTENSION 270
2.7%
19 OFF LABEL USE 260
2.6%
20 PNEUMONIA 254
2.5%
21 FEELING ABNORMAL 253
2.5%
22 VOMITING 241
2.4%
23 PAIN IN EXTREMITY 238
2.3%
24 RENAL FAILURE 227
2.2%
25 ACUTE KIDNEY INJURY 220
2.2%
26 ARTHRALGIA 217
2.1%
27 BLOOD PRESSURE DECREASED 215
2.1%
28 COUGH 211
2.1%
29 PRURITUS 206
2.0%
30 GAIT DISTURBANCE 205
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.