Drug Safety Information for STIMATE (Desmopressin acetate)

Safety-related Labeling Changes for MINIRIN (DESMOPRESSIN ACETATE) Rx Drug: FDA Link

Adverse Drug Reactions for STIMATE* (Desmopressin acetate)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with STIMATE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Hyponatraemia409
2Drug ineffective178
3Headache*166
4Vomiting163
5Convulsion162
6Nausea149
7Dizziness*93
8Confusional state91
9Fall90
10Fatigue87
11Pyrexia85
12Craniopharyngioma84
13Asthenia82
14Diarrhoea81
15Condition aggravated81
16Drug interaction79
17Pain79
18Malaise77
19Death75
20Blood sodium decreased75

* This side effect also appears in "Top 10 Side Effects of STIMATE " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking STIMATE
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Diabetes insipidus*1567
2Product used for unknown indication1192
3Enuresis*893
4Hypopituitarism291
5Blood antidiuretic hormone decreased270
6Von willebrand's disease253
7Nocturia244
8Urinary incontinence145
9Ill-defined disorder113
10Haemorrhage79

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for STIMATE

Total Reports Filed with FDA: 12331


Number of FDA Adverse Event Reports by Patient Age for STIMATE

Total Reports Filed with FDA: 12331*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Desmopressin acetate (Desmogalen, Concentraid, Desmopressin, Desmospray, Adiuretin sd, Minirin, Nocutil, Desmotabs, Octostim, Ddavp, Stimate, Desmopressin acetate)

Charts are based on 12331 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and STIMATE Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.