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Symlin

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Symlin

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: Nausea, vomiting, tiredness, and upset stomach may occur as your body adjusts to the medication. Nausea can be reduced by starting at a low dose and increasing the dose slowly. Redness, swelling, and itching at the injection site may occur and usually go away in a few days. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Though pramlintide does not cause low blood sugar (hypoglycemia) by itself, this effect can occur because it is used with insulin. This may also occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor immediately about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your dosage may need to be increased.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or 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

Adverse events (excluding hypoglycemia, discussed below) commonly associated with SYMLIN (pramlintide acetate injection) when co-administered with a fixed dose of insulin in the long-term, placebo-controlled trials in insulin-using type 2 patients and type 1 patients are presented in Table 4 and Table 5, respectively. The same adverse events were also shown in the open-label clinical practice study, which employed flexible insulin dosing.

Table 4: Treatment-Emergent Adverse Events Occurring With ≥ 5% Incidence and Greater Incidence With SYMLIN (pramlintide acetate injection) Compared With Placebo in Long-Term, Placebo-Controlled Trials. Incidence of the Same Events in the Open-Label Clinical Practice Study (Patients With Insulin-Using Type 2 Diabetes, 120 mcg)

  Long-Term, Placebo-Controlled Studies Open-Label, Clinical Practice Study
  Placebo + Insulin
(n(%))
(N=284)
SYMLIN (pramlintide acetate injection) + Insulin
(n(%))
(N=292)
SYMLIN (pramlintide acetate injection) + Insulin
(n(%))
(N=166)
Nausea 34 (12) 81 (28) 53 (30)
Headache 19 (7) 39 (13) 8 (5)
Anorexia 5 (2) 27 (9) 1 (<1)
Vomiting 12 (4) 24 (8) 13 (7)
Abdominal Pain 19 (7) 23 (8) 3 (2)
Fatigue 11 (4) 20 (7) 5 (3)
Dizziness 11 (4) 17 (6) 3 (2)
Coughing 12 (4) 18 (6) 4 (2)
Pharyngitis 7 (2) 15 (5) 6 (3)

Table 5: Treatment-Emergent Adverse Events Occurring With ≥ 5% Incidence and Greater Incidence with SYMLIN (pramlintide acetate injection) Compared to Placebo in Long-Term, Placebo-Controlled Studies. Incidence of the Same Events in the Open-Label Clinical Practice Study (Patients With Type 1 Diabetes, 30 or 60 mcg)

  Long-Term, Placebo-Controlled Studies Open-Label, Clinical Practice Study
  Placebo + Insulin
(n(%))
(N=538)
SYMLIN (pramlintide acetate injection) + Insulin
(n(%))
(N=716)
SYMLIN (pramlintide acetate injection) + Insulin
(n(%))
(N=265)
Nausea 92 (17) 342 (48) 98 (37)
Anorexia 12 (2) 122 (17) 0 (0)
Inflicted Injury 55 (10) 97 (14) 20 (8)
Vomiting 36 (7) 82 (11) 18 (7)
Arthralgia 27 (5) 51 (7) 6 (2)
Fatigue 22 (4) 51 (7) 12 (4.5)
Allergic Reaction 28 (5) 41 (6) 1 (<1)
Dizziness 21 (4) 34 (5) 5 (2)

Most adverse events were gastrointestinal in nature. In patients with type 2 or type 1 diabetes, the incidence of nausea was higher at the beginning of SYMLIN (pramlintide acetate injection) treatment and decreased with time in most patients. The incidence and severity of nausea are reduced when SYMLIN (pramlintide acetate injection) is gradually titrated to the recommended doses (see DOSAGE AND ADMINISTRATION).

Severe Hypoglycemia

SYMLIN (pramlintide acetate injection) alone (without the concomitant administration of insulin) does not cause hypoglycemia. However, SYMLIN (pramlintide acetate injection) is indicated as an adjunct treatment in patients who use mealtime insulin therapy and co-administration of SYMLIN (pramlintide acetate injection) with insulin can increase the risk of insulin-induced hypoglycemia, particularly in patients with type 1 diabetes (see BOXED WARNING). The incidence of severe hypoglycemia during the SYMLIN (pramlintide acetate injection) clinical development program is summarized in Table 6 and Table 7.

Table 6: Incidence and Event Rate of Severe Hypoglycemia in Long-Term, Placebo-Controlled and Open-Label, Clinical Practice Studies in Patients With Insulin-Using Type 2 Diabetes

  Long-Term, Placebo-Controlled Studies (No Insulin Dose-Reduction During Initiation) Open-Label, Clinical Practice Study (Insulin Dose-Reduction During Initiation)
  Placebo + Insulin SYMLIN + Insulin SYMLIN + Insulin
Severe Hypoglycemia 0-3 Months
(n=284)
>3-6 Months
(n=251)
0-3 Months
(n=292)
>3-6 Months
(n=255)
0-3 Months
(n=166)
>3-6 Months
(n=150)
Patient-Ascertained*
  Event Rate (event rate/patient year) 0.24 0.13 0.45 0.39 0.05 0.03
  Incidence (%) 2.1 2.4 8.2 4.7 0.6 0.7
Medically Assisted**
  Event Rate (event rate/patient year) 0.06 0.07 0.09 0.02 0.05 0.03
  Incidence (%) 0.7 1.2 1.7 0.4 0.6 0.7
* Patient-ascertained severe hypoglycemia: Requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention.
** Medically assisted severe hypoglycemia: Requiring glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or assessed as an SAE by the investigator.

Table 7: Incidence and Event Rate of Severe Hypoglycemia in Long-Term, Placebo-Controlled and Open-Label, Clinical Practice Studies in Patients With Type 1 Diabetes

  Long-Term, Placebo-Controlled Studies (No Insulin Dose-Reduction During Initiation) Open-Label,Clinical PracticeStudy (Insulin Dose-Reduction During Initiation)
  Placebo + Insulin SYMLIN + Insulin SYMLI N + Insulin
Severe Hypoglycemia 0-3 Months
(n=538)
>3-6 Months
(n=470)
0-3 Months
(n=716)
>3-6 Months
(n=576)
0-3 Months
(n=265)
>3-6 Months
(n=213)
Patient-Ascertained*
  Event Rate (event rate/patient year) 1.33 1.06 1.55 0.82 0.29 0.16
  Incidence (%) 10.8 8.7 16.8 11.1 5.7 3.8
Medically Assisted**
  Event Rate (event rate/patient year) 0.19 0.24 0.50 0.27 0.10 0.04
  Incidence (%) 3.3 4.3 7.3 5.2 2.3 0.9
* Patient-ascertained severe hypoglycemia: Requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention.
** Medically assisted severe hypoglycemia: Requiring glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or assessed as an SAE by the investigator.

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

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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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