Drug Safety Information for SANDOSTATIN (Octreotide acetate)

Safety-related Labeling Changes for SANDOSTATIN (OCTREOTIDE ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for SANDOSTATIN LAR (OCTREOTIDE ACETATE) Rx Drug: FDA Link

Adverse Drug Reactions for SANDOSTATIN* (Octreotide 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 SANDOSTATIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Death1785
2Diarrhoea1327
3Fatigue839
4Neoplasm malignant804
5Nausea783
6Asthenia701
7Abdominal pain664
8Malaise662
9Weight decreased629
10Blood pressure increased593
11Pain*584
12Vomiting583
13Dyspnoea525
14Headache441
15Dizziness428
16Blood pressure systolic increased397
17Fall395
18Injection site pain392
19Decreased appetite384
20Pyrexia361

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

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

Reason # of FDA Reports
1Acromegaly7788
2Carcinoid tumour6476
3Neuroendocrine tumour6153
4Carcinoid syndrome3429
5Pancreatic neuroendocrine tumour2037
6Metastatic carcinoid tumour1552
7Product used for unknown indication1129
8Neuroendocrine carcinoma1085
9Diarrhoea652
10Off label use498

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


Types of Adverse Events for SANDOSTATIN

Total Reports Filed with FDA: 51931


Number of FDA Adverse Event Reports by Patient Age for SANDOSTATIN

Total Reports Filed with FDA: 51931*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Octreotide acetate (Octreotide, Sandostatin lar, Sandostatin, Octreotide acetate)

Charts are based on 51931 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 SANDOSTATIN 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.