Tolvaptan

Common brands: Samsca, Jynarque, Lasix, Furosemide, Lasix Onyu

Top reporter: Otsuka America Pharmaceutical, Inc.

Vasopressin V2 Receptor Antagonist [EPC]Loop Diuretic [EPC]Aldosterone Antagonist [EPC]Angiotensin 2 Receptor Blocker [EPC]Dihydropyridine Calcium Channel Blocker [EPC]
13,906
Total Reports
8,605
Serious Reports
3,134
Death Reports
30
Reported Reactions
Death Report Ratio: High (22.54%)

Patient Demographics

Male
5,671
Female
5,611

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Tolvaptan.

# Reaction Reports % of Total
1 DEATH 997
7.0%
2 THIRST 860
6.0%
3 OFF LABEL USE 850
6.0%
4 RENAL IMPAIRMENT 828
5.8%
5 CARDIAC FAILURE 802
5.6%
6 PRODUCT DOSE OMISSION ISSUE 652
4.6%
7 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS 504
3.5%
8 PRODUCT USE IN UNAPPROVED INDICATION 490
3.4%
9 UNDERDOSE 480
3.4%
10 DEHYDRATION 460
3.2%
11 POLLAKIURIA 453
3.2%
12 NO ADVERSE EVENT 439
3.1%
13 POLYURIA 434
3.0%
14 BLOOD CREATININE INCREASED 432
3.0%
15 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION 428
3.0%
16 NAUSEA 420
2.9%
17 PRODUCT USE ISSUE 387
2.7%
18 DIARRHOEA 382
2.7%
19 PNEUMONIA 374
2.6%
20 FATIGUE 371
2.6%
21 BLOOD SODIUM DECREASED 364
2.6%
22 HYPERNATRAEMIA 362
2.5%
23 HEPATIC FUNCTION ABNORMAL 347
2.4%
24 DYSPNOEA 329
2.3%
25 DIZZINESS 317
2.2%
26 DECREASED APPETITE 316
2.2%
27 HYPONATRAEMIA 306
2.1%
28 HEADACHE 294
2.1%
29 BLOOD UREA INCREASED 290
2.0%
30 MALAISE 288
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.