Drug Safety Information for SYMLIN (Pramlintide acetate)

FDA Safety-related Labeling Changes for SYMLIN (PRAMLINTIDE ACETATE) Rx Drug: Safety Information Link

Adverse Drug Reactions for SYMLIN* (Pramlintide 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 SYMLIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Blood glucose increased843
2Nausea640
3Blood glucose decreased338
4Weight decreased310
5Decreased appetite262
6Injection site pain243
7Drug ineffective196
8Fatigue154
9Medication error135
10Vomiting131
11Dizziness126
12Diarrhoea122
13Injection site haematoma114
14Weight increased111
15Hypoglycaemia103
16Headache84
17Incorrect dose administered81
18Feeling abnormal78
19Abdominal distension78
20Drug effect decreased76

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

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

Reason # of FDA Reports
1Type 2 diabetes mellitus3948
2Type 1 diabetes mellitus2292
3Diabetes mellitus591
4Product used for unknown indication494
5Weight decreased51
6Obesity50
7Weight control33
8Glucose tolerance impaired31
9Insulin resistance23
10Insulin resistant diabetes10

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


Types of Adverse Events for SYMLIN

Total Reports Filed with FDA: 9313


Number of FDA Adverse Event Reports by Patient Age for SYMLIN

Total Reports Filed with FDA: 9313*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Pramlintide acetate (Pramlintide, Pramlintide acetate, Symlinpen, Symlin)

Charts are based on 9313 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 SYMLIN 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.