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Pramlintide: Medicine Overview

Pramlintide (brand Symlin) is an amylin analogue approved in the US as an add-on for people with diabetes who use mealtime insulin; this page covers label indications, trials and safety.

Content last updated . This page has not been medically reviewed.

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Quick overview

Pramlintide is an amylin analogue: a lab-made version of a natural hormone called amylin. In the United States it is sold as Symlin, an injection that comes in pen form. This page explains what the official label says. It is education only and does not tell anyone whether to use, start, change or stop a medicine. Questions about diabetes treatment belong with the prescriber.

Evidence label used here: approved medicine. The US Food and Drug Administration (FDA) approved Symlin, with initial approval listed as 2005. [1]

Molecule, brand and product

  • Active ingredient: pramlintide (as pramlintide acetate). Brand as labeled: Symlin, supplied in the SymlinPen pen-injector. [1]
  • What it copies: the label calls pramlintide an analogue of human amylin. Amylin is released together with insulin by the pancreatic beta cells after food. [1]
  • A brand, a molecule and a pen device are related but not interchangeable. This page describes the product as the label describes it.

How it is thought to work

Per the label, nonclinical studies show amylin slows how fast food leaves the stomach and lowers glucagon release after meals. In human studies pramlintide slowed gastric emptying, reduced the after-meal rise in glucagon and changed satiety, which led to lower calorie intake. [1] Compare this with the GLP-1 medicines in GLP-1 Medicines: Semaglutide, Tirzepatide and Liraglutide, which act on a different hormone system, and see Glucagon and Amylin Biology for the underlying biology.

What the trials showed

The label summarizes placebo-controlled trials of 26 to 52 weeks in people with type 1 diabetes (three trials) and type 2 diabetes using mealtime insulin (two trials). [1]
Measure at 6 monthsType 1 diabetes trialsType 2 diabetes trials
HbA1c (a blood test of average glucose) compared with placeboAbout 0.25 to 0.34 percentage points lowerAbout 0.30 to 0.34 percentage points lower
Body weightAverage loss of 0.8 to 1.6 kg versus average gain of 0.4 to 0.8 kg on placeboAverage loss of 1.4 to 1.6 kg versus average gain of 0.1 to 0.3 kg on placebo

[1] These are modest average differences, and HbA1c and weight are biomarkers, not direct measures of complications. The label's numbers are group averages and say nothing about how any one person would respond.

Special groups

For pregnancy, the label says the small amount of human data is not enough to determine a drug-related risk. Animal studies at high exposures found birth abnormalities in rats but not rabbits. Poorly controlled diabetes in pregnancy carries its own risks. [1] There is no data on pramlintide in human milk. [1]

Monitoring and professional care

The label places pramlintide inside a supervised plan: patient selection by a clinician skilled in insulin use, frequent glucose monitoring, and stopping criteria that include recurrent unexplained hypoglycemia and persistent nausea. [1] Any change to insulin when this medicine is involved is a decision for the care team. See Metabolic and Diabetes Peptide Medicines for how pramlintide fits beside insulin and GLP-1 drugs.

Off-label and investigational questions

Uses outside the label, such as for weight loss in people without diabetes, are not part of the approval. Proper evidence not found in the sources checked for this page (the FDA label only; trial literature on other uses was not reviewed). Do not read the label's weight results as evidence for a weight-loss use.

Frequently asked questions

Is pramlintide insulin?

No. Pramlintide copies amylin, a different hormone that is released alongside insulin. The label says it is used with mealtime insulin and must be injected separately from it. [1]

Is pramlintide a weight-loss drug?

Its approved use is as an add-on for diabetes. Average weight loss was seen in the trials, but the label does not list weight loss as an indication. [1]

Why is there a boxed warning?

Because adding it to insulin raised the risk of severe low blood sugar, mostly in type 1 diabetes. [1]

Is it approved outside the United States?

Not verified for this page. Only the US label was read.

Where can I read more about related medicines?

More details: evidence, limits and cautions

The details behind this page: cautions, limits of the evidence and where sources disagree. Open any note to read it.

Approved use (United States)
The FDA label for Symlin says it is an adjunctive (add-on) treatment for people with type 1 or type 2 diabetes who use mealtime insulin and have not reached the glucose control they wanted despite optimal insulin therapy. [1] It is not a stand-alone diabetes drug and it is not a weight-loss medicine. The label read for this page was the DailyMed version dated 2019-12-18. Approval status in other countries was not verified for this page.
Major safety information
  • Boxed warning: severe hypoglycemia (very low blood sugar). The label says use with insulin raises the risk of severe hypoglycemia, particularly in type 1 diabetes, with episodes seen within 3 hours after an injection. It also warns that injuries may occur while driving or doing other high-risk activities. [1]
  • Who the label excludes: it is contraindicated in people with a serious allergic reaction to it, hypoglycemia unawareness, or confirmed gastroparesis (delayed stomach emptying). [1]
  • Common side effects: nausea was reported in 48% of people with type 1 diabetes on pramlintide versus 17% on placebo, and in 28% versus 12% in type 2 diabetes. Vomiting, loss of appetite and headache were also common. [1]
  • Other medicines: because it slows stomach emptying, the label advises against use with other drugs that change gut movement and notes it can affect how quickly oral medicines are absorbed. [1]
  • Pens are never shared: the label says a SymlinPen must never be shared between people, even with a new needle. [1]
References
Education, not medical advice. This page is for general information. It does not diagnose or treat any condition and is not a substitute for care from a qualified health professional. Natural does not automatically mean safe. Ask a clinician or pharmacist before changing your care, especially if you take medication, are pregnant or breastfeeding, or have a health condition.