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).
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For the consumer For the professional
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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:
Seek medical attention right away if any of these SEVERE side effects occur 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.
TopSevere 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.
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.
| 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) |
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| 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) |
| 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) |
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| 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.
| Long-Term, Placebo-Controlled Studies (No Insulin Dose-Reduction During Initiation) |
Open-Label, Clinical Practice Study (Insulin Dose-Reduction During Initiation) |
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|---|---|---|---|---|---|---|
| Placebo + Insulin | Symlin + Insulin | Symlin + Insulin | ||||
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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 |
| Long-Term, Placebo-Controlled Studies (No Insulin Dose-Reduction During Initiation) |
Open-Label, Clinical Practice Study (Insulin Dose-Reduction During Initiation) |
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|---|---|---|---|---|---|---|
| Placebo + Insulin | Symlin + Insulin | Symlin + Insulin | ||||
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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 |
More resources:
Symlin - Includes detailed dosage instructions.
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