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Side Effects > Symlin

Symlin Side Effects

Please note - some side effects for Symlin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).


For the consumer

For the professional

Side Effects of Symlin - for the consumer


Symlin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Symlin:

Coughing; decreased appetite; dizziness; indigestion; nausea; redness, swelling, itching, or pain at the injection site reaction; sore throat; stomach pain; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Symlin:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); low blood sugar (eg, increased heartbeat, headache, chills, sweating, tremor, increased hunger, changes in vision, nervousness, weakness, dizziness, drowsiness, fainting, irritability, difficulty concentrating); severe or continuing nausea.

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For the professional


Symlin

Adverse events (excluding hypoglycemia, discussed below) commonly associated with Symlin 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 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 + Insulin
(n(%))
(N=292)
Symlin + 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 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 + Insulin (n(%))
(N=716)
Symlin + 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 treatment and decreased with time in most patients. The incidence and severity of nausea are reduced when Symlin is gradually titrated to the recommended doses.

Severe Hypoglycemia

Symlin alone (without the concomitant administration of insulin) does not cause hypoglycemia. However, Symlin is indicated as an adjunct treatment in patients who use mealtime insulin therapy and co-administration of Symlin with insulin can increase the risk of insulin-induced hypoglycemia, particularly in patients with type 1 diabetes. The incidence of severe hypoglycemia during the Symlin 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
*
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.

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
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 Practice Study
(Insulin Dose-Reduction During Initiation)
Placebo + Insulin Symlin + Insulin Symlin + Insulin
*
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.

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

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More resources:

Drugs.com Symlin

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Micromedex Symlin - Includes detailed dosage instructions.

FDA Symlin

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