July 28, 2015
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Symlin

" Type 2 diabetes usually begins with insulin resistance, a condition in which the body produces insulin but isn't able to use it effectively. As a result, glucose builds up in blood and may ultimately damage nerves, blood vessels, and other b"...

Symlin




Symlin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Symlin (pramlintide acetate) Injection is used together with insulin to treat type 1 or type 2 diabetes. It is an antihyperglycemic drug. Common side effects include nausea, vomiting, tiredness, and upset stomach as your body adjusts to the medication. Redness, swelling, and itching at the injection site may occur and usually go away in a few days.

The dose of Symlin depends on the type of diabetes being treated. Symlin may interact with acarbose, miglitol, atropine, belladonna, benztropine, dimenhydrinate, methscopolamine, scopolamine, bronchodilators, glycopyrrolate, mepenzolate, bladder or urinary medications, or irritable bowel medications. Medicines that can make it harder for you to tell when you have low blood sugar include albuterol, clonidine, cholesterol-lowering medications, or ACE inhibitors. Hyperglycemia (high blood sugar) may result if Symlin is taken with isoniazid, diuretics (water pills), steroids, phenothiazines, thyroid medicine, birth control pills and other hormones, seizure medicines, diet pills or medicines to treat asthma, colds or allergies. Hypoglycemia (low blood sugar) may result if Symlin is taken with probenecid, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates, sulfa drugs, monoamine oxidase inhibitors (MAOIs), or beta-blockers. Tell your doctor all medications and supplements you use. During pregnancy, Symlin should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Symlin (pramlintide acetate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Symlin in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe nausea that lasts for 3 to 7 days; or
  • more frequent high blood sugar levels.

Less serious side effects may include:

  • runny or stuffy nose, sore throat, cough;
  • nausea, loss of appetite;
  • headache, tired feeling; or
  • joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Symlin (Pramlintide Acetate Injection)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Symlin Overview - Patient Information: Side Effects

SIDE EFFECTS: Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Symlin (Pramlintide Acetate Injection)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Symlin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trial Experience

Adverse Reactions (Excluding Hypoglycemia)

Adverse reactions (excluding hypoglycemia, which is discussed separately below) commonly associated with SYMLIN when coadministered with a fixed dose of insulin in the 26-to 52-week, placebo-controlled trials in patients with type 1 diabetes and patients with type 2 diabetes on mealtime insulin are presented in Table 1 and Table 2, respectively.

Table 1: Patients with Type 1 Diabetes: Common Adverse Reactions (Incidence ≥ 5% and Greater Incidence with SYMLIN Compared to Placebo) in 3 Pooled Placebo-Controlled Trials

  Long-Term, Placebo-Controlled Studies
SYMLIN 30 or 60 mcg 3 Times Daily + Insulin
(N=716) %
Placebo + Insulin
(N=538) %
Nausea 48 17
Anorexia 17 2
Inflicted Injury1 14 10
Vomiting 11 7
Arthralgia 7 5
Fatigue 7 4
Allergic Reaction 6 5
Dizziness 5 4
1Examples of inflicted injury included among others, abrasions, bruises, burns, fractures, lacerations, and muscle strains.

 

Table 2: Patients with Type 2 Diabetes on Insulin: Common Adverse Reactions (Incidence ≥ 5% and Greater Incidence with SYMLIN Compared to Placebo) in 2 Pooled Placebo-Controlled Trials

  Long-Term, Placebo-Controlled Studies
SYMLIN 120 mcg 2 Times Daily + Insulin
(N=292) %
Placebo + Insulin
(N=284) %
Nausea 28 12
Headache 13 7
Anorexia 9 2
Vomiting 8 4
Abdominal pain 8 7
Fatigue 7 4
Dizziness 6 4
Cough 6 4
Pharyngitis 5 2

Most adverse reactions were gastrointestinal in nature. The incidence of nausea is higher at the beginning of SYMLIN treatment and decreases with time in most patients. Gradual titration of the SYMLIN dose minimizes the incidence and severity of nausea [see DOSAGE AND ADMINISTRATION].

Severe Hypoglycemia

Coadministration of SYMLIN with mealtime insulin increases the risk of severe hypoglycemia, particularly in patients with type 1 diabetes [see BOXED WARNING and WARNINGS AND PRECAUTIONS].

Two definitions of severe hypoglycemia were used in the SYMLIN clinical trials. Patient-ascertained severe hypoglycemia was defined as an episode of hypoglycemia requiring the assistance of another individual (including help administering oral carbohydrate) or requiring the administration of glucagon, intravenous glucose, or other medical intervention. Medically-assisted severe hypoglycemia was defined as an episode of hypoglycemia that was classified as a serious event by the investigator or that required glucagon, intravenous glucose, hospitalization, paramedic assistance or an emergency room visit. The incidence of severe hypoglycemia during the SYMLIN clinical development program is summarized in Table 3 and Table 4.

Table 3: Incidence and Event Rate of Severe Hypoglycemia in Six-Month, Placebo-Controlled Trials and Dose Titration Trial in Patients with Type 1 Diabetes

Severe Hypoglycemia Long-Term, Placebo-Controlled Studies (No Insulin Dose-Reduction During Initiation) Placebo-Controlled Dose Titration Study
SYMLIN + Insulin Placebo + Insulin SYMLIN + Insulin Placebo + Insulin
0 to 3 Months
(n=716)
> 3 to 6 Months
(n=576)
0 to 3 Months
(n=538)
> 3 to 6 Months
(n=470)
0 to 3 Months
(n=148)
> 3 to 6 Months
(n=133)
0 to 3 Months
(n=147)
> 3 to 6 Months
(n=138)
Patient- Ascertained1
  Event Rate (events/patient- year) 1.55 0.82 1.33 1.06 0.69 0.49 0.28 0.3
  Subject Incidence (%) 16.8 11.1 10.8 8.7 13.5 10.5 6.1 5.8
Medically- Assisted2
  Event Rate (events/patient-year) 0.50 0.27 0.19 0.24 0.14 0.20 0.08 0.15
  Subject Incidence (%) 7.3 5.2 3.3 4.3 3.4 4.5 2.0 2.9
1Patient-ascertained severe hypoglycemia: Requiring the assistance of another individual (including help ingesting oral carbohydrate) and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention.
2Medically-assisted severe hypoglycemia: Requiring glucagon, intravenous glucose, hospitalization, paramedic assistance, emergency room visit, and/or assessed as a serious adverse event by the investigator.

Table 4: Incidence and Event Rate of Severe Hypoglycemia in Six-Month, Placebo-Controlled Trials in Patients with Type 2 Diabetes Using Insulin

Severe Hypoglycemia Long-Term, Placebo-Controlled Studies (No Insulin Dose-Reduction During Initiation)
SYMLIN + Insulin Placebo + Insulin
0 to 3 Months
(n=292)
> 3 to 6 Months
(n=255)
0 to 3 Months
(n=284)
> 3 to 6 Months
(n=251)
Patient-Ascertained1
  Event Rate (events/patient-year) 0.45 0.39 0.24 0.13
  Subject Incidence (%) 8.2 4.7 2.1 2.4
Medically-Assisted2
  Event Rate (events/patient-year) 0.09 0.02 0.06 0.07
  Subject Incidence (%) 1.7 0.4 0.7 1.2
1Patient-ascertained severe hypoglycemia: Requiring the assistance of another individual (including help ingesting oral carbohydrate) and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention.
2Medically-assisted severe hypoglycemia: Requiring glucagon, intravenous glucose, hospitalization, paramedic assistance, emergency room visit, and/or assessed as a serious adverse event by the investigator.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of SYMLIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Read the entire FDA prescribing information for Symlin (Pramlintide Acetate Injection)

Symlin - User Reviews

Symlin User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Symlin sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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