Vial Guide

A synthetic copy of amylin, a hormone the pancreas releases with insulin after meals, with three amino acids changed. Injected just before meals, it slows stomach emptying, curbs the after-meal rise in glucagon and increases fullness.

Evidence. FDA-approved in 2005 as Symlin, a mealtime injection added to insulin for type 1 or type 2 diabetes; in 6-month trials it lowered HbA1c about 0.3 points more than insulin alone, with modest weight loss. AstraZeneca has stopped making it, and FDA listed both SymlinPen strengths as discontinued in October 2025. No pramlintide product is listed in the EU, UK, Canada or Australia.

What it’s used for

Approved uses first, then uses tested in people, then claims that rest on animal studies or user reports.

Type 1 diabetes, with mealtime insulin
LabelApproved for this, though no longer sold in the US. Over 6 months, HbA1c, a 3-month blood sugar average, fell 0.25–0.34 points more than with insulin alone.
Type 2 diabetes, with mealtime insulin
LabelApproved for this, though no longer sold in the US. Over 6 months, 120 mcg before meals lowered HbA1c 0.30–0.34 points more than placebo, with 1.4–1.6 kg weight loss.
Weight loss in obesity
TrialModest and never approved: with a lifestyle program, adults without diabetes lost 6–7 kg more than on placebo at 12 months, counting only those still in the trial.
Type 2 diabetes on basal insulin only
TrialPositive but unapproved: added to insulin glargine for 16 weeks in 212 adults, HbA1c fell 0.70 vs 0.36 points on placebo, and weight fell 1.6 kg vs a 0.7 kg gain.
Automated insulin pumps (artificial pancreas)
TrialEarly signal: in a small 24-hour crossover study in type 1 diabetes, adding pramlintide to rapid insulin in a closed-loop system raised time in target range from 74% to 84%.

Label: an approved use. Trial: tested in people, with the result.

Every compound’s uses, by body system: evidence map, and by condition: conditions A to Z.

Status

Approval
Approved in the US in March 2005 as Symlin (later SymlinPen 60 and 120) for type 1 or type 2 diabetes in people using mealtime insulin who haven’t reached their glucose goals. AstraZeneca stopped making it, and FDA lists both pens as discontinued (posted October 27, 2025).
Approval history
  • 2005US FDA: Symlin: added to mealtime insulin in type 1 or type 2 diabetes
  • 2025US FDA: SymlinPen: discontinued in the US by AstraZeneca
US compounding
Not on FDA’s 503A or 503B bulk lists or in their nomination categories, and not on the list of drugs withdrawn for safety. FDA’s drug shortage database lists both SymlinPen strengths under discontinuations (October 27, 2025), not as a shortage.
European Union
No marketing authorization; EMA’s medicines data list no pramlintide product.
United Kingdom
No marketing authorization; no UK product information for pramlintide is listed.
Canada
No marketing authorization; Health Canada’s Drug Product Database lists no pramlintide product.
Australia
No product registered; the TGA lists no product information for pramlintide.
Sport (WADA 2026)
Not banned in sportNot named on the 2026 list; S4.4.2 bans insulins and insulin-mimetics, not amylin analogs. S0 covers drugs with no current approval, including discontinued ones; Symlin’s US approval hasn’t been withdrawn, though it’s no longer sold.

Category 2 is FDA’s list of bulk substances that may present significant safety risks in compounding. The 503A bulks list adds substances that pharmacies may compound with. Advisory committee votes are advice; FDA makes the final decision. Sport status follows the WADA Prohibited List in force since January 1, 2026; athletes should confirm with their anti-doping organization. Checked October 5, 2026. Status outside the US checked October 7, 2026 against EMA, MHRA, Health Canada and TGA records. By country: EU, UK, Canada, Australia. Status of every compound.

How it works

Pramlintide is a copy of amylin, a hormone the pancreas releases along with insulin after meals, with three amino acids changed. People with type 1 diabetes, and many with type 2, make too little of it. In studies, pramlintide slowed stomach emptying, blunted the after-meal rise in glucagon (a hormone that pushes blood sugar up) and increased fullness: a single dose cut calories eaten at a buffet by about a fifth. Together these flatten the rise in blood sugar after meals.

LabelBased on the product label.

Not known

The label draws parts of the mechanism from animal studies and doesn’t say how much each effect matters. Effects beyond about 2 years of use, and in kidney failure or liver disease, haven’t been studied.

Protocol

Label

Symlin

Type 2 diabetes on mealtime insulin: 60 mcg just before each major meal, rising to 120 mcg once there has been no significant nausea for 3 days. Mealtime insulin is cut by 50% at the start.

Label

Symlin

Type 1 diabetes: 15 mcg before each major meal, rising in 15 mcg steps, each after 3 days without significant nausea, to 30 or 60 mcg. Mealtime insulin is cut by 50% at the start.

Trial

Smith 2008

Weight loss without diabetes (never approved): 120 mcg 3× daily or 360 mcg 2× daily before meals, with a lifestyle program, for 12 months.

Frequency
Before each major meal
Route
Subcutaneous injection (belly or thigh)
Timing
Immediately before each major meal (at least 250 kcal or 30 g of carbohydrate), as a separate injection from insulin.
Cycle
Continuous. The label treats it as ongoing therapy alongside insulin, not a cycle.

Continuous, shown over 26 weeks

Common protocols

The ways Pramlintide is most often run, each tagged with where it comes from.

Type 2 diabetes (Symlin)

Label
Dose
60 mcg rising to 120 mcg
How often
Before each major meal
How long
Long-term

Mealtime insulin is cut 50% at the start. The step up waits for 3 days without significant nausea; the dose goes back to 60 mcg if nausea persists at 120 mcg.

Type 1 diabetes (Symlin)

Label
Dose
15 mcg rising to 30–60 mcg
How often
Before each major meal
How long
Long-term

15 mcg steps, each after 3 nausea-free days. If 45 or 60 mcg isn’t tolerated, the dose drops to 30 mcg; if 30 mcg isn’t tolerated, the label suggests stopping.

Obesity without diabetes

Trial
Dose
120 mcg 3× daily or 360 mcg 2× daily
How often
Before meals
How long
12 months

With a lifestyle program; never approved for weight loss. Weight fell 6–7 kg more than on placebo at 12 months, counting only those still in the study (Smith 2008).

Type 2 diabetes on basal insulin only

Trial
Dose
60 or 120 mcg
How often
2–3× daily before meals
How long
16 weeks

Added to insulin glargine without mealtime insulin, which isn’t the labeled use. HbA1c fell 0.70 vs 0.36 points on placebo, with 1.6 kg weight loss vs a 0.7 kg gain (Riddle 2007).

Symlin step-up, type 1 diabetes

PeriodDose
Start (mealtime insulin cut 50%)15 mcg
Step 2 (after 3+ days without nausea)30 mcg
Step 3 (after 3+ more days)45 mcg
Step 4 (maximum)60 mcg

Each step waits for at least 3 days without significant nausea; 30 or 60 mcg is the usual maintenance dose. Type 2 diabetes: 60 mcg, then 120 mcg after 3 nausea-free days.

Taking it

Where it goes

Under the skin of the belly or thigh, not the arm, where absorption varies; at least 2 inches from any insulin injection, rotating sites (label). Letting the pen reach room temperature first reduces site reactions.

If you miss a dose

Symlin label: skip the missed dose and take the usual dose before the next major meal; don’t take extra. If it’s stopped for surgery or illness, it’s restarted with the starting steps, including the 50% insulin cut.

Missed doses for every compound

What to expect

  1. First days to weeks

    Nausea is most common at the start and fades for most people; each dose step waits for 3 days without significant nausea.

    Label
  2. Within 3 hours of each dose

    If severe low blood sugar happens, it usually comes in this window, especially in type 1 diabetes.

    Label
  3. 6 months

    HbA1c fell 0.25–0.34 points more than placebo in type 1 and 0.30–0.34 more in type 2 diabetes; weight fell 0.8–1.6 kg vs small gains on placebo.

    Label
  4. 52 weeks

    In type 2 diabetes, 120 mcg 2× daily kept HbA1c 0.62 points below baseline, with 1.4 kg weight loss vs a 0.7 kg gain on placebo.

    Trial

Side effects and what to do

Nausea (label: 48% vs 17% on placebo in type 1 diabetes; 28% vs 12% in type 2)

Most common early. The label waits for 3 nausea-free days before each step and lowers the dose if nausea persists.

Severe low blood sugar with insulin (label: lows needing help in 16.8% vs 10.8% on placebo in the first 3 months, type 1 diabetes)

Boxed warning. Check glucose before and after meals and carry fast sugar or glucagon. More frequent milder lows are a warning sign.

Loss of appetite (label: 17% vs 2% in type 1 diabetes) and vomiting (11% vs 7%)

Eating less on the same insulin dose raises the risk of lows; the label notes nausea can change insulin needs.

Headache (label: 13% vs 7% on placebo in type 2 diabetes)

Usually mild. Headache can also be a sign of low blood sugar.

Injection-site redness, swelling or itching

Usually clears within days to weeks. Rotate sites and let the pen warm to room temperature first.

Stop and get medical help

Severe low blood sugar needing help, repeated unexplained lows, or nausea that won’t settle (the label’s stop rules); also severe belly pain that won’t go away (pancreatitis has been reported) or face or throat swelling.

Can it cause …?

The side effects people ask about most, answered one by one. Each answer says where it comes from.

Tiredness
LabelFatigue: 7% vs 4% on placebo in both the type 1 and type 2 diabetes trials.
Headache
LabelHeadache: 13% vs 7% on placebo in type 2 diabetes. In a study of 36 people with migraine, a pramlintide infusion set off migraine-like attacks in 41%.
Nausea or vomiting
LabelNausea 48% vs 17% on placebo in type 1 diabetes and 28% vs 12% in type 2; vomiting 11% vs 7% and 8% vs 4%. It fades over time.
Diarrhea or constipation
LabelBelly pain: 8% vs 7% on placebo in type 2 diabetes. Diarrhea and constipation aren’t among the label’s common side effects, though diarrhea followed a large overdose.
Dizziness
LabelDizziness: 5% vs 4% on placebo in type 1 and 6% vs 4% in type 2 diabetes. Dizziness and shakiness can also signal low blood sugar.
Trouble sleeping
Not reportedTrouble sleeping isn’t listed in the label, whose 26- to 52-week trials gave pramlintide to 2,333 people with type 1 and 1,852 with type 2 diabetes.
Hair loss
Not reportedHair loss isn’t listed in the label (26- to 52-week trials in over 4,000 people on pramlintide).
Acne, rash or skin changes
LabelInjection-site redness, swelling or itching can occur and usually clears within days to weeks. Allergic reactions: 6% vs 5% on placebo in type 1 diabetes.
Water retention or swelling
LabelFluid retention isn’t a listed side effect. Swelling at the injection site can occur and usually resolves within days to weeks.
Joint or muscle pain
LabelJoint pain: 7% vs 5% on placebo in type 1 diabetes.
Anxiety, low mood or irritability
Not reportedAnxiety or low mood isn’t listed in the label (over 4,000 people on pramlintide). Irritability can be a sign of low blood sugar, which it makes likelier with insulin.
Low or high blood sugar
LabelBoxed warning: severe lows with insulin, mostly in type 1 diabetes, within 3 hours of a dose. Lows needing help: 16.8% vs 10.8% on placebo in the first 3 months.
Fast heartbeat or blood pressure changes
Not reportedHeart rate or blood pressure changes aren’t listed in the label. A fast heartbeat can be a sign of low blood sugar.
More hunger
LabelIt reduces appetite: loss of appetite 17% vs 2% on placebo in type 1 diabetes, and a single dose cut calories eaten at a buffet by about a fifth.
Liver strain
LabelLiver problems aren’t a listed side effect. It hasn’t been studied in people with liver impairment.
Kidney problems
LabelKidney problems aren’t a listed side effect. No dose change down to severe impairment (creatinine clearance 15–29 mL/min); not studied in kidney failure.
Cancer risk
LabelNo drug-related tumors appeared in 2-year studies in mice and rats at 3–159 times the human exposure. The label describes no cancer signal in people.

Label: from the prescribing information. Not reported: studied in people and not reported. A side effect that hasn’t been reported can still happen, especially with long or high-dose use. Any of these across every compound: the side-effect finder.

Who should avoid it

What its label rules out or warns about, most important first.

Hypoglycemia unawareness (not feeling lows)
LabelRuled out. Pramlintide raises the risk of severe low blood sugar with insulin, and people who don’t notice early warning signs can’t act on them.
Gastroparesis (very slow stomach emptying)
LabelRuled out when confirmed, because pramlintide slows stomach emptying further.
Serious allergy to pramlintide
LabelRuled out after a serious reaction to pramlintide or any ingredient, such as the metacresol preservative.
Recent severe lows or HbA1c over 9%
LabelThe label says not to consider it after severe lows needing help in the past 6 months, with HbA1c above 9%, or when insulin doses and glucose checks aren’t kept up.
People taking drugs that change gut movement
LabelNot recommended with drugs that alter gut movement, such as atropine, or that slow nutrient absorption, such as acarbose; these users weren’t studied.
Pregnancy
LabelHuman data are too few to judge the risk. In rats, exposures 10–47 times the human level caused birth defects such as neural tube defects, though not at the highest dose tested.
Children and teens
LabelSafety and effectiveness aren’t established under 18, and the label says it isn’t recommended in children because of the risk of severe low blood sugar.

Interactions

Only interactions stated on a product label or measured in a human study are listed.

Insulin (all types)
LabelNever mixed in one syringe: premixing changed pramlintide’s peak level by up to 40% and insulin exposure by up to 20%. Mealtime insulin is cut 50% at the start to limit lows.
Oral medicines that must act fast (such as pain relievers, antibiotics and birth-control pills)
LabelSlower stomach emptying delays absorption: taken 0–2 hours after a dose, acetaminophen’s peak fell 20–29%. The label advises taking them 1 hour before or 2 hours after pramlintide.
Birth-control pills
LabelTaken 15 minutes after a dose, norgestrel’s peak fell about 30% and came 45 minutes later; ethinyl estradiol didn’t change. The clinical relevance is unknown.
Drugs that change gut movement (such as atropine) or slow nutrient absorption (such as acarbose)
LabelThe label says pramlintide shouldn’t be considered with these; people taking them weren’t studied.
Drugs that can lower blood sugar (other diabetes drugs, ACE inhibitors, fluoxetine, MAO inhibitors, salicylates, sulfa antibiotics, somatostatin analogs)
LabelThey may add to the risk of low blood sugar, so the label advises caution and closer glucose checks.
Beta-blockers, clonidine, guanethidine or reserpine
LabelThese can blunt or hide the warning signs of low blood sugar, the label notes.

Label: a product label rules it out, warns about it or lists the interaction. This isn’t a complete list: a pharmacist or doctor can check a specific medicine or condition. Every documented interaction, by medicine: drug interactions.

Special situations

What the label and studies say about pregnancy, breastfeeding, kidney and liver problems, age and surgery.

Pregnancy
LabelToo few human reports to judge the risk. Little crossed placentas in lab tests; in rats, 10–47 times the human exposure caused birth defects. Poorly controlled diabetes itself harms pregnancy.
Breastfeeding
LabelNo data on pramlintide in breast milk or on breastfed babies. The label weighs breastfeeding’s benefits against the mother’s need for the drug and possible risks.
Kidney problems
LabelNo dose change for mild to severe impairment (creatinine clearance 15–89 mL/min), though drug levels varied widely. Not studied in end-stage kidney disease or dialysis.
Liver problems
LabelNot studied in liver impairment, and the label gives no dose advice for it.
Older adults
LabelStudied in 769 people aged 65–75 and 87 over 75, with no consistent differences; greater sensitivity in some can’t be ruled out, and insulin needs careful handling.
Children and teens
LabelNot approved under 18; safety and effectiveness aren’t established, and the label says it isn’t recommended in children because of the risk of severe low blood sugar.
Surgery and anesthesia
LabelIf it’s stopped for surgery or illness, the label restarts it with the starting steps, including the 50% cut in mealtime insulin. It slows stomach emptying, so the care team needs to know.

Label: what the prescribing information says. Ages are given as approved or studied; this site never gives doses for children. Across every compound: pregnancy, breastfeeding, kidney disease, liver disease, older adults and surgery.

Tracking and pairing

Worth tracking

  • Blood sugar before and after meals and at bedtime
  • How often mild or moderate lows occur
  • Mealtime insulin doses
  • HbA1c
  • Nausea before each dose step

Often paired with

Usually run on its own.

Human studies

5 key published human studies, with how many people took part. Animal studies aren’t listed here.

  1. 2003656 people

    With 120 mcg 2× daily, HbA1c fell 0.62 points from baseline, significantly more than placebo, and weight fell 1.4 kg vs a 0.7 kg gain; 46% vs 28% reached HbA1c under 8%.

    Design
    Randomized double-blind placebo-controlled trial in type 2 diabetes treated with insulin
    Dose
    60 mcg 3× daily, 90 mcg 2× daily or 120 mcg 2× daily before meals
    Length
    52 weeks

    Hollander et al., Diabetes Care 2003, PMID 12610038

  2. 2004651 people

    HbA1c fell 0.29 and 0.34 points vs 0.04 on placebo; weight fell 0.4 kg vs a 0.8 kg gain. Mild to moderate nausea was the most common side effect.

    Design
    Randomized double-blind placebo-controlled trial in type 1 diabetes
    Dose
    60 mcg 3× or 4× daily before meals (other doses also tested), with insulin
    Length
    52 weeks

    Ratner et al., Diabet Med 2004, PMID 15498087

  3. 2002480 people

    HbA1c fell 0.67 vs 0.16 points at 13 weeks, and a placebo-corrected difference held through 52 weeks, with weight loss instead of gain and no rise in the overall rate of severe lows.

    Design
    Randomized double-blind placebo-controlled trial in type 1 diabetes, with a 1-year open-label extension
    Dose
    30 or 60 mcg 4× daily before meals, with insulin
    Length
    52 weeks, plus 1-year extension (236 people)

    Whitehouse et al., Diabetes Care 2002, PMID 11919132

  4. 2008411 people

    Among those still evaluable at 12 months (146), weight fell 6.1 kg (120 mcg 3× daily) and 7.2 kg (360 mcg 2× daily) more than placebo; 40–43% vs 12% lost at least 10%.

    Design
    Randomized double-blind placebo-controlled dose-ranging trial in obesity without diabetes, with an 8-month single-blind extension
    Dose
    120–360 mcg 2× or 3× daily before meals, with a lifestyle program
    Length
    4 months, plus 8-month extension

    Smith et al., Diabetes Care 2008, PMID 18753666

  5. 2006296 people

    HbA1c fell 0.5 points in both groups, but post-meal glucose swings and weight (−1.3 vs +1.2 kg) fell more; nausea 63% vs 36%; severe lows 0.57 vs 0.30 per patient-year.

    Design
    Randomized double-blind placebo-controlled trial in type 1 diabetes, with dose escalation and mealtime insulin cuts
    Dose
    15 mcg rising to 60 mcg per meal, with 30–50% less mealtime insulin
    Length
    29 weeks

    Edelman et al., Diabetes Care 2006, PMID 17003291

All human studies on Vial Guide

Trials under way

Registered trials that are still running, or that finished without published results, most important first. Checked on ClinicalTrials.gov, October 7, 2026.

  1. Early phase 1NCT03560960

    A single pramlintide dose as a blood test for Alzheimer’s disease: whether it briefly raises amyloid-beta levels in the blood, in 57 people

    Active, not recruiting; completion expected November 2026

  2. Not applicable (physiology study)NCT07506369

    Pramlintide infusion with or without pancreatic polypeptide, another pancreatic hormone, in 18 healthy adults: effect on how much they eat

    Recruiting since April 2026; completion expected October 2028

  3. Not applicable (physiology study)NCT07340788

    Whether a pramlintide infusion triggers migraine attacks in 21 people with migraine without aura, compared with placebo

    Not yet recruiting; completion expected October 2028

  4. Not applicable (physiology study)NCT07340775

    Whether pramlintide triggers migraine-like headache in 21 people with lasting headache after a mild brain injury, compared with placebo

    Not yet recruiting; completion expected December 2028

  5. Phase 2/3NCT06046417

    A fully automated insulin (Lyumjev) and pramlintide delivery system vs a hybrid closed loop with carbohydrate counting in 30 adults with type 1 diabetes

    Status unknown (last updated April 2024); completion was expected June 2025, no results posted

Every compound’s registered trials: trials under way.

Limits of the evidence

Approval rests on 26- to 52-week placebo-controlled trials in about 2,300 adults with type 1 and 1,850 with type 2 diabetes on insulin, where HbA1c fell about 0.3 points more than with insulin alone. No trial measured heart, kidney or survival outcomes. Weight-loss trials without diabetes lasted up to a year and never led to approval. There are no data in kidney failure, liver disease, children or pregnancy, and the product is no longer sold in the US.

How it’s supplied

Ready-made pens of 1,000 mcg/mL: SymlinPen 60 (15, 30, 45 or 60 mcg doses) and SymlinPen 120 (60 or 120 mcg doses). The pen measures each dose, so there’s nothing to mix or draw up.

SymlinPen is a ready-made solution dialed in micrograms; nothing is mixed. An earlier, discontinued 600 mcg/mL vial was measured in insulin-syringe units (60 mcg was 10 units), so unit doses from the vial don’t apply to the pen.

Datasheet

Half-life
about 48 minutes LabelAfter an injection under the skin in healthy adults; 48–55 minutes across 30–120 mcg doses. Levels peak about 20 minutes after a dose, and 30–40% of the dose reaches the blood.
Type
Peptide, 37 amino acids
Molecular weight
3,949.4 g/mol
Formula
C171H267N51O53S2
Sequence
KCNTATCATQRLANFLVHSSNNFGPILPPTNVGSNTY-NH2A disulfide bond joins C2 and C7; prolines at positions 25, 28 and 29 replace human amylin’s A, S and S
Storage before use
Not a powder: pens hold a ready-made solution. Before first use, refrigerate at 2–8 °C and protect from light; never freeze, and don’t use a pen that has frozen.
After mixing or opening
After first use, keep in the fridge or at up to 30 °C, and use within 30 days whether or not refrigerated.
  • Half-life: SymlinPen prescribing information (label effective 12/2019), sections 10 and 12.3
  • Molecule: SymlinPen label, section 11 (formula and MW as free base; supplied as the acetate); PubChem CID 70691388; UNII D3FM8FA78T
  • Storage: Label SymlinPen prescribing information (label effective 12/2019), section 16, and Medication Guide

Every compound side by side: the half-life chart and the storage chart.

Identifiers

UNII (FDA)
D3FM8FA78T; 726I6TE06G (acetate)
PubChem CID
70691388; 118984456 (acetate)
DrugBank
DB01278
ATC code
A10BX05
CAS number
151126-32-8 (pramlintide); 196078-30-5 (acetate)
Development codes
AC137 (AC-0137), 25,28,29-tripro-amylin
Brand names
Symlin, SymlinPen 60 and SymlinPen 120 (US only; discontinued)
First described
Developed at Amylin Pharmaceuticals as AC137; first human results published in 1995. First approved: US, March 2005.

Every compound’s numbers: the identifiers table.

Product form and quality

SymlinPen holds pramlintide acetate at 1,000 mcg/mL, dialed in micrograms. A discontinued 600 mcg/mL vial was measured in insulin-syringe units, and an older label warned that drawing pen solution into a syringe could cause overdosing. It’s never mixed with insulin.

Cautions

  • Boxed warning: severe low blood sugar when used with insulin, especially in type 1 diabetes, usually within 3 hours of a dose. The label cuts mealtime insulin by 50% at the start and calls for frequent glucose checks.
  • Ruled out with hypoglycemia unawareness (not feeling lows), confirmed gastroparesis (very slow stomach emptying) or a past serious allergy to it.
  • Nausea is common (48% vs 17% on placebo in type 1 diabetes) and fades; doses step up only after 3 days without it.
  • Never mixed with insulin in one syringe. It slows stomach emptying, so pills that must act fast are taken 1 hour before or 2 hours after.
  • No longer sold in the US: FDA listed both SymlinPen strengths as discontinued in October 2025.

Questions

What is pramlintide?

A synthetic copy of amylin, a hormone the pancreas releases with insulin after meals, with three amino acids changed. Injected just before meals, it slows stomach emptying, curbs the after-meal rise in glucagon and increases fullness.

How does pramlintide work?

Pramlintide is a copy of amylin, a hormone the pancreas releases along with insulin after meals, with three amino acids changed. People with type 1 diabetes, and many with type 2, make too little of it. In studies, pramlintide slowed stomach emptying, blunted the after-meal rise in glucagon (a hormone that pushes blood sugar up) and increased fullness: a single dose cut calories eaten at a buffet by about a fifth. Together these flatten the rise in blood sugar after meals. The label draws parts of the mechanism from animal studies and doesn’t say how much each effect matters. Effects beyond about 2 years of use, and in kidney failure or liver disease, haven’t been studied.

Is pramlintide FDA-approved?

Approved in the US in March 2005 as Symlin (later SymlinPen 60 and 120) for type 1 or type 2 diabetes in people using mealtime insulin who haven’t reached their glucose goals. AstraZeneca stopped making it, and FDA lists both pens as discontinued (posted October 27, 2025). Not on FDA’s 503A or 503B bulk lists or in their nomination categories, and not on the list of drugs withdrawn for safety. FDA’s drug shortage database lists both SymlinPen strengths under discontinuations (October 27, 2025), not as a shortage.

What is the usual pramlintide dose?

From the label (Symlin): Type 2 diabetes on mealtime insulin: 60 mcg just before each major meal, rising to 120 mcg once there has been no significant nausea for 3 days. Mealtime insulin is cut by 50% at the start. Type 1 diabetes: 15 mcg before each major meal, rising in 15 mcg steps, each after 3 days without significant nausea, to 30 or 60 mcg. Mealtime insulin is cut by 50% at the start. These are the amounts sources reference, not recommendations.

How is pramlintide given?

Ready-made pens of 1,000 mcg/mL: SymlinPen 60 (15, 30, 45 or 60 mcg doses) and SymlinPen 120 (60 or 120 mcg doses), injected under the skin. Immediately before each major meal (at least 250 kcal or 30 g of carbohydrate), as a separate injection from insulin. The pen measures each dose, so there’s nothing to mix.

Who should avoid pramlintide?

Hypoglycemia unawareness (not feeling lows): Ruled out. Pramlintide raises the risk of severe low blood sugar with insulin, and people who don’t notice early warning signs can’t act on them. Gastroparesis (very slow stomach emptying): Ruled out when confirmed, because pramlintide slows stomach emptying further. Serious allergy to pramlintide: Ruled out after a serious reaction to pramlintide or any ingredient, such as the metacresol preservative. The “Who should avoid it” section lists 4 more groups and 6 interactions.

What is the half-life of pramlintide?

About 48 minutes, according to the prescribing information. After an injection under the skin in healthy adults; 48–55 minutes across 30–120 mcg doses. Levels peak about 20 minutes after a dose, and 30–40% of the dose reaches the blood.

How should pramlintide be stored?

Not a powder: pens hold a ready-made solution. Before first use, refrigerate at 2–8 °C and protect from light; never freeze, and don’t use a pen that has frozen. After first use, keep in the fridge or at up to 30 °C, and use within 30 days whether or not refrigerated.

Is pramlintide banned in sport?

No. Not named on the 2026 list; S4.4.2 bans insulins and insulin-mimetics, not amylin analogs. S0 covers drugs with no current approval, including discontinued ones; Symlin’s US approval hasn’t been withdrawn, though it’s no longer sold.

Has pramlintide been studied in people?

Yes. The human studies section lists 5 published studies. The largest, from 2003, included 656 people. With 120 mcg 2× daily, HbA1c fell 0.62 points from baseline, significantly more than placebo, and weight fell 1.4 kg vs a 0.7 kg gain; 46% vs 28% reached HbA1c under 8%.

How long has pramlintide been studied in people?

Trial About 2 years: after a 52-week type 1 diabetes trial, 236 people continued pramlintide in a 1-year open-label extension. Most trials lasted 26–52 weeks.

Does pramlintide come in other forms, like a pill or nasal spray?

Label Only injections under the skin of the belly or thigh are approved; the arm gave 20–36% higher, more variable exposure. Combined insulin-pramlintide shots and dual-hormone pumps remain experimental.

Can you drink alcohol while taking pramlintide?

Label The Medication Guide says drinking alcohol may raise the chance of severe low blood sugar while using pramlintide with insulin.

Can pramlintide be taken with semaglutide or tirzepatide?

Precaution Published trials haven’t tested pramlintide together with a GLP-1 drug. Both slow stomach emptying, and its label advises against other drugs that alter gut movement. Cagrilintide, an amylin analog, is being tested with semaglutide.

What happens if you take too much pramlintide?

Label Per the label, single 10 mg doses (83 times the top dose) gave 3 volunteers severe nausea, vomiting, diarrhea, flushing and dizziness, without low sugar. Call Poison Help (1-800-222-1222), or emergency services for severe symptoms.

Sources

  • SymlinPen (pramlintide acetate) prescribing information, label effective 12/2019 (AstraZeneca, DailyMed)
  • Drugs@FDA: Symlin (NDA 021332), approved March 16, 2005; all products listed as discontinued (checked October 2026)
  • FDA Drug Shortages database: pramlintide acetate injection, discontinuation posted October 27, 2025
  • Hollander et al., pramlintide in type 2 diabetes, 1-year trial (Diabetes Care 2003) PMID 12610038
  • Smith et al., 12-month pramlintide treatment in obesity (Diabetes Care 2008) PMID 18753666

For the protocol details

  • SymlinPen (pramlintide acetate) prescribing information, label effective 12/2019, sections 2, 5, 6 and 14 (DailyMed)
  • Riddle et al., pramlintide added to basal insulin in type 2 diabetes (Diabetes Care 2007) PMID 17698615

For how it works, who should avoid it and the limits of the evidence

  • SymlinPen (pramlintide acetate) prescribing information, boxed warning and sections 4, 5, 7, 8, 12 and 14 (AstraZeneca, DailyMed, label effective 12/2019)
  • Ratner et al., pramlintide in type 1 diabetes, 1-year trial (Diabet Med 2004) PMID 15498087

For uses, the side-effect questions, special situations, trials, identifiers and status outside the US

  • SymlinPen (pramlintide acetate) prescribing information and Medication Guide, sections 2, 4, 5, 6, 8, 10, 12, 13 and 14 (AstraZeneca, DailyMed, label effective 12/2019)
  • Symlin prescribing information, vial dosing in insulin-syringe units (Amylin Pharmaceuticals, Drugs@FDA, 2007)
  • Kolterman et al., AC137, a human amylin analogue, in type 1 diabetes (Diabetes Care 1995) PMID 7587855
  • Whitehouse et al., pramlintide in type 1 diabetes with open-label extension (Diabetes Care 2002) PMID 11919132
  • Haidar et al., dual-hormone insulin-and-pramlintide artificial pancreas (Diabetes Care 2020) PMID 31974099
  • Ghanizada et al., pramlintide induces migraine-like attacks (Ann Neurol 2021) PMID 33772845
  • FDA Global Substance Registration System records and WHO ATC index entry for pramlintide
  • EMA medicines data (October 2026), UK electronic medicines compendium, Health Canada Drug Product Database and TGA product information search (checked October 8, 2026)
  • ClinicalTrials.gov registry entries for the trials listed (checked October 8, 2026)