Prescription medicine
Pramlintide Brand names: Symlinpen; first approved as Symlin
Pramlintide (Symlin) is a prescription medicine with an FDA approval on record since 2005. No generic is listed in FDA's NDC Directory.
- No generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the pramlintide FDA label on DailyMed (effective December 18, 2019, AstraZeneca Pharmaceuticals LP); the NDA 21332 record on Drugs@FDA; every pramlintide label on DailyMed.
Highlights of the record
FDA label of December 18, 2019; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SEVERE HYPOGLYCEMIA.
SYMLIN use with insulin increases the risk of severe hypoglycemia, particularly in patients with type 1 diabetes. When severe hypoglycemia occurs, it is seen within 3 hours following a SYMLIN injection. Serious injuries may occur if severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high-risk activities. Appropriate patient selection, careful patient instruction, and insulin dose reduction are critical elements for reducing this risk. WARNING: SEVERE HYPOGLYCEMIA See full prescribing information for complete boxed warning.
SYMLIN use with insulin has been associated with an increased risk of severe hypoglycemia, particularly in patients with type 1 diabetes.
Hypoglycemia risk may be reduced by appropriate patient selection, careful patient instruction, and insulin dose reduction (5.1 , 5.2).
Used for
From the label: indications and usageSYMLIN is indicated as an adjunctive treatment in patients with type 1 or type 2 diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy.
Forms and strengths
Injection.
On the market
- Earliest approval on file
- March 16, 2005 Symlin, Astrazeneca Ab; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 2 past records
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 102 through July 30, 2026
What is pramlintide used for?
From the label: indications and usageSYMLIN is indicated as an adjunctive treatment in patients with type 1 or type 2 diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy. SYMLIN is an amylin analog indicated for patients with type 1 or type 2 diabetes who use mealtime insulin and have failed to achieve desired glycemic control despite optimal insulin therapy (1).
Conditions named in the indications of pramlintide's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Amylin Analog.
Source: FDA drug label (SymlinPen), AstraZeneca Pharmaceuticals LP, effective December 18, 2019 (SPL set 4aea30ff-eb0d-45c1-b114-3127966328ff), via openFDA; the full label on DailyMed
What does the patient leaflet for pramlintide say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about SYMLIN?SYMLIN can cause serious side effects, including: • severe low blood sugar (hypoglycemia). Even when SYMLIN is carefully added to your mealtime insulin therapy, your blood sugar may drop too low, especially if you have type 1 diabetes. If this severe low blood sugar (hypoglycemia) happens, it is seen within 3 hours after a SYMLIN injection. Symptoms of severe low blood sugar and low blood sugar include: o lightheadedness o dizziness o shakiness o sweating o hunger o fast heartbeat o trouble concentrating or confusion o change in vision o headache o irritability o drowsiness People who have severely low blood sugar have had injuries while driving their car, operating heavy machinery or doing other dangerous activities. You and your healthcare provider should talk about a plan to treat low blood sugar. You should have fast-acting sugar (such as hard candy, glucose tablets, juice) or glucagon for injection with you at all times. Call your healthcare provider if you have severe low blood sugar or if you have low blood sugar more often than normal. You have a higher chance of getting severe low blood sugar if you: o do not follow your healthcare provider’s instructions to reduce your insulin use before meals o use more SYMLIN or insulin than prescribed by your healthcare provider o change your insulin dose without checking your blood sugar o eat less food than your usual meal o are sick and cannot eat o are more active than usual o have a low blood sugar level before eating o drink alcohol SYMLIN is used with insulin to lower blood sugar, especially high blood sugar that happens after meals. SYMLIN is taken at mealtimes. The use of SYMLIN does not replace your daily insulin but may lower the amount of insulin you need, especially before meals. […]
From the patient leaflet: What should I avoid while taking SYMLIN?See “What is the most important information I should know about SYMLIN?” • Do not drive, operate machinery, or do other dangerous activities until you know how SYMLIN affects you. Talk to your healthcare provider about the activities you should avoid. • Alcohol. Drinking alcohol may increase your chances of getting severe low blood sugar.
From the patient leaflet: How should I store SYMLIN?Unopened SYMLIN: • Keep SYMLIN in the refrigerator between 36°F to 46°F (2°C to 8°C), until you are ready to use it. • Do not freeze. Do not use SYMLIN if it has been frozen. • Keep unopened SYMLIN out of the light. Opened SYMLIN: • Keep SYMLIN either in the refrigerator or at room temperature between 36°F to 86°F (2°C to 30°C) for up to 30 days. • Throw away used SYMLIN after 30 days of use, even if the pen still has medicine in it. • Do not use SYMLIN (opened or unopened) after the expiration (EXP) date printed on the carton and the label. Keep SYMLIN and all medicines out of the reach of children.
Source: FDA drug label (SymlinPen), AstraZeneca Pharmaceuticals LP, effective December 18, 2019 (SPL set 4aea30ff-eb0d-45c1-b114-3127966328ff), via openFDA; the full label on DailyMed
Is there a generic for pramlintide (Symlin)?
No generic pramlintide is approved (Drugs@FDA, October 8, 2026).
- 2005 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is pramlintide in shortage?
No pramlintide presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated October 27, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| SymlinPen® 120 , Injection, 1000 ug/1 mL (NDC 0310-6627-02) | AstraZeneca AB | To Be Discontinued | October 27, 2025 |
| SymlinPen® 60 , Injection, 1000 ug/1 mL (NDC 0310-6615-02) | AstraZeneca AB | To Be Discontinued | October 27, 2025 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
What does the pramlintide label say about other medicines?
The pramlintide label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 13 other medicines name pramlintide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atropine | drug interactions | Due to its effects on gastric emptying, SYMLIN should not be considered for patients taking medications that alter gastrointestinal motility (e.g., anticholinergic agents such as atropine) or medications that slow the intestinal absorption of nutrients (e.g., alpha-glucosidase inhibitors). |
| Clonidine | warnings and precautions | Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as longstanding diabetes; diabetic neuropathy; use of medications such as beta-blockers, clonidine, guanethidine, or reserpine; or intensified glycemic control. |
| Disopyramide | drug interactions | The following are examples of medications that may increase the susceptibility to hypoglycemia when administered with SYMLIN: anti-diabetic products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, salicylates, somatostatin analogs, and … |
| Fluoxetine | drug interactions | The following are examples of medications that may increase the susceptibility to hypoglycemia when administered with SYMLIN: anti-diabetic products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, salicylates, somatostatin analogs, and … |
| Pentoxifylline | drug interactions | The following are examples of medications that may increase the susceptibility to hypoglycemia when administered with SYMLIN: anti-diabetic products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, salicylates, somatostatin analogs, and … |
Other labels that name pramlintide
Source: FDA drug label (SymlinPen), AstraZeneca Pharmaceuticals LP, effective December 18, 2019 (SPL set 4aea30ff-eb0d-45c1-b114-3127966328ff), via openFDA; the full label on DailyMed
What do FAERS reports show for pramlintide?
The FDA Adverse Event Reporting System holds 102 reports that list pramlintide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10 are coded as a death and 25 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as pramlintide?
14 other medicines are given the same way (subcutaneous) and in the same FDA class as pramlintide or labeled mainly for the same use (type 2 diabetes), the same class first. Type 2 diabetes lists all 52 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Tirzepatide | Type 2 diabetes | none listed | $538.68 per mL 10 mg/0.5 mL pen | No current entry |
| Insulin glargine | Type 2 diabetes, Type 1 diabetes | none listed | $2.90 per mL 100 pen | A presentation being discontinued |
| Liraglutide | Type 2 diabetes | 9 labelers | $31.41 per mL 2-pak 18 mg/3 mL | In shortage |
| Insulin aspart | Type 2 diabetes, Type 1 diabetes | none listed | $6.95 per mL 100 unit/mL vial | No current entry |
| Insulin lispro | Type 2 diabetes, Type 1 diabetes | none listed | $10.19 per mL 100 unit/mL kwikpen | A presentation being discontinued |
| Semaglutide | Type 2 diabetes | none listed | $331.99 per mL 0.25-0.5 mg/dose (2 mg/3 mL) pen | A presentation being discontinued |
| Insulin human | Type 2 diabetes, Type 1 diabetes | none listed | $4.26 per mL 70-30 vial | No current entry |
| Dulaglutide | Type 2 diabetes | none listed | $487.57 per mL 0.75 mg/0.5 mL pen | No current entry |
Every medicine labeled for the same conditions as pramlintide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to pramlintide
- 14 medicines for the same use
- Pramlintide side effects
- the label's list beside FAERS reports
- Pramlintide shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other