Short answer: Low blood sugar (hypoglycemia) is the most common Tresiba side effect, as with all insulin. Leaving that aside, the label's adult trials list nasopharyngitis or common cold (23.9% in type 1, 12.9% in type 2), upper respiratory infections, headache, sinusitis, gastroenteritis and diarrhea. Injection site reactions occurred in 3.8% and average weight gain was 1.8 to 3.0 kg over 52 weeks. Tresiba has no boxed warning.
What Tresiba is approved for: Tresiba is a long-acting human insulin analog approved to improve blood sugar control in people 1 year of age and older with diabetes (section 1). It is not recommended for treating diabetic ketoacidosis.
Source
TRESIBA (insulin degludec) injection, for subcutaneous use, prescribing information, Patient Information and Instructions for Use. Novo Nordisk. DailyMed, version published July 20, 2022. DailyMed setid 456c5e87-3dfd-46fa-8ac0-c6128d4c97c6
No. The current Tresiba label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Tresiba.
| Adverse reaction | TRESIBA (N=1,102) |
|---|---|
| Nasopharyngitis | 23.9 % |
| Upper respiratory tract infection | 11.9 % |
| Headache | 11.8 % |
| Sinusitis | 5.1 % |
| Gastroenteritis | 5.1 % |
Three open-label trials, 1,102 adults with type 1 diabetes, mean 34 weeks on Tresiba with mealtime insulin. Hypoglycemia is not in this table; it is covered in Table 3. There was no placebo group.
| Adverse reaction | TRESIBA (N=2,713) |
|---|---|
| Nasopharyngitis | 12.9 % |
| Headache | 8.8 % |
| Upper respiratory tract infection | 8.4 % |
| Diarrhea | 6.3 % |
Six open-label trials, 2,713 adults with type 2 diabetes, mean 36 weeks on Tresiba. Hypoglycemia is not in this table; it is covered in Table 4.
| Study and arm | Severe hypoglycemia, percent of patients | Hypoglycemia, percent of patients |
|---|---|---|
| Study A, adults, 52 weeks, TRESIBA (N=472) | 12.3% | 95.6% |
| Study B, adults, 26 weeks, TRESIBA (N=301) | 10.6% | 93.0% |
| Study C, adults, 26 weeks, TRESIBA at the same time each day (N=165) | 12.7% | 99.4% |
| Study C, adults, 26 weeks, TRESIBA at alternating times (N=164) | 10.4% | 93.9% |
| Study J, pediatrics, 52 weeks, TRESIBA (N=174) | 17.8% | 98.3% |
All arms used insulin aspart at meals. Severe hypoglycemia in adults means needing another person's help; hypoglycemia means a severe episode or glucose below 56 mg/dL (plasma-calibrated) or below 50 mg/dL (whole blood), with or without symptoms.
| Study and arm | Severe hypoglycemia, percent of patients | Hypoglycemia, percent of patients |
|---|---|---|
| Study D, + 1-2 OADs, insulin naive, 52 weeks (N=766) | 0.3% | 46.5% |
| Study E, + 1-2 OADs, insulin naive, 26 weeks (N=228) | 0 | 28.5% |
| Study F, ± 1-3 OADs, insulin naive, 26 weeks (N=284) | 0 | 50% |
| Study G, ± 0-3 OADs, 26 weeks (N=226) | 0.9% | 43.8% |
| Study G, ± 0-3 OADs, 26 weeks, alternating time (N=230) | 0.4% | 50.9% |
| Study H, ± 0-2 OADs + insulin aspart, 52 weeks (N=753) | 4.5% | 80.9% |
| Study I, ± 1-2 OADs, insulin naive, 26 weeks (N=226) | 0.4% | 42.5% |
OAD means oral antidiabetic agent. Definitions are the same as in Table 3.
Allergic reactions (such as swelling of the tongue and lips, diarrhea, nausea, tiredness and itching) and hives were reported in 0.9% of patients on Tresiba.
Injection site reactions (bruising, pain, bleeding, redness, nodules, swelling, discoloration, itching, warmth, lumps) occurred in 3.8%. Lipodystrophy (thickened or thinned fat at injection sites) was reported in 0.3%.
After 52 weeks, average weight gain was 1.8 kg in type 1 and 3.0 kg in type 2 diabetes. Swelling of the legs or feet occurred in 0.9% (type 1) and 3.0% (type 2).
In 174 children aged 1 and older with type 1 diabetes, common side effects were similar to those in adults with type 1 diabetes.
Reported after approval: localized cutaneous amyloidosis (lumps under the skin) at the injection site.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Who should not use it. Tresiba is not used during an episode of low blood sugar, or by people allergic to insulin degludec or its ingredients.
Never share pens, needles or syringes. A Tresiba FlexTouch pen is never shared, even if the needle is changed, and vial needles and syringes are never shared, because of the risk of passing on blood-borne infections.
Changes in insulin regimen. Changing insulin strength, maker, type, injection site or method can cause high or low blood sugar, so changes are made under close supervision with more glucose checks. Injecting into lumpy or thickened skin can raise blood sugar, and switching to normal skin can lower it suddenly.
Low blood sugar. Hypoglycemia is the most common reaction to insulin, and severe episodes can cause seizures or death. Tresiba's long action may delay recovery from a low compared with shorter-acting insulins. Awareness of lows may be reduced with long diabetes, nerve damage, beta-blockers or repeated lows.
Medication mix-ups. Mix-ups between insulin products have happened, so the label is checked before each injection. A syringe is never used to draw Tresiba out of the pen, to avoid overdose.
Serious allergic reactions. Severe, life-threatening whole-body allergy, including anaphylaxis, can occur; Tresiba is stopped if it does.
Low potassium. All insulins shift potassium into cells and can cause low potassium, which untreated can cause breathing paralysis, heart rhythm problems and death.
Heart failure with TZDs. Thiazolidinediones (such as pioglitazone) with insulin can cause fluid retention that may lead to or worsen heart failure.
From the Patient Information that comes with Tresiba:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.