Symlin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Symlin?

Symlin (pramlintide acetate) injection 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.

What Are Side Effects of Symlin?

Common side effects of Symlin include:

nausea,
vomiting,
loss of appetite,
headache,
joint pain,
fatigue,
allergic reaction, and
dizziness

Seek medical care or call 911 at once if you have the following serious side effects:

Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Symlin

Upon initiation of Symlin, reduce mealtime insulin dose by 50%. The initial dose of Symlin for type 1 diabetes is 15 mcg subcutaneously before major meals. Increase in 15 mcg increments to a maximum premeal dose of 30 or 60 mcg; if not tolerated, reduce to 30 mcg, as tolerated The initial dose of Symlin for type 2 diabetes is 60 mcg subcutaneously before major meals then increase to 120 mcg before meals, as tolerated.

What Drugs, Substances, or Supplements Interact with Symlin?

Symlin may interact with insulin, anticholinergics, alpha-glucosidase inhibitors, oral anti-diabetic drugs, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, propoxyphene, salicylates, somatostatin analogs, and sulfonamide antibiotics ("sulfa" drugs). Symlin may delay the absorption of oral medications taken at the same time. Take oral medications at least 1 hour prior to Symlin injection or 2 hours after Symlin injection. Tell your doctor all medications and supplements you use.

Symlin During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Symlin; it is unknown how it would affect a fetus. It is unknown if Symlin passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Symlin (pramlintide acetate) Injection 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.

QUESTION

About how much does an adult human brain weigh? See Answer

Symlin Consumer Information

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

Call your doctor at once if you have:

severe ongoing nausea; or
severe hypoglycemia--headache, dizziness, drowsiness, vision problems, hunger, weakness, sweating, confusion, irritability, fast heart rate, feeling jittery.

Common side effects may include:

nausea, vomiting, loss of appetite; or
headache.

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.

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow

Symlin Professional Information

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 mealtimeinsulin 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
¹ Examples 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
¹ Patient-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. ² Medically-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
¹ Patient-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. ² Medically-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.

Injection site reactions
Pancreatitis

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