Drug Safety Information for TRELSTAR (Triptorelin pamoate)

Safety-related Labeling Changes for TRELSTAR (TRIPTORELIN PAMOATE) Rx Drug: FDA Link

Safety-related Labeling Changes for TRELSTAR (TRIPTORELIN PAMOATE) Rx Drug: FDA Link

Safety-related Labeling Changes for TRIPTODUR KIT (TRIPTORELIN PAMOATE) Rx Drug: FDA Link

Adverse Drug Reactions for TRELSTAR* (Triptorelin pamoate)

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 TRELSTAR
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Ovarian hyperstimulation syndrome97
2Asthenia54
3Ascites50
4Dyspnoea49
5Fatigue*47
6Nausea*44
7Vomiting42
8Headache*37
9Anaemia34
10Pyrexia*34
11Hot flush*32
12Pain*31
13Abdominal pain30
14Osteonecrosis29
15Anxiety28
16Oedema peripheral28
17Back pain*26
18Dizziness26
19Depression25
20Hypertension25

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

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

Reason # of FDA Reports
1Prostate cancer729
2Breast cancer*325
3Product used for unknown indication316
4In vitro fertilisation235
5Endometriosis107
6Precocious puberty91
7Infertility82
8Ovulation induction66
9Assisted fertilisation61
10Prostate cancer metastatic61

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


Types of Adverse Events for TRELSTAR

Total Reports Filed with FDA: 4656


Number of FDA Adverse Event Reports by Patient Age for TRELSTAR

Total Reports Filed with FDA: 4656*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Triptorelin pamoate (Decapeptyl, Decapeptyl depot, Trelstar la, Trelstar depot, Trelstar)

Charts are based on 4656 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 TRELSTAR 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.