Prescription medication · Ultra-Long-Acting Insulin
insulin degludec
Also sold as Tresiba.
Data updated 2026-05-15
- 22,011
- FDA reportsModerately reported
- 12
- InteractionsSeveral interactions
- 65% less
- Generic vs brandBig savings
- $32.52
- Brand price (NADAC)
What the data shows
insulin degludec (Tresiba) is a prescription Ultra-Long-Acting Insulin, reported at a middle-of-the-pack volume (22,011 FDA reports), whose generic runs roughly half the brand price or less (65% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$32.52/unit
Generic Price
$11.39/unit
Generic Savings
65%
Generic Available
Yes (0 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Information not available.
Common side effects
Common cold, Headache, Feeling sick to your stomach
Key warnings
No specific warnings noted. Always follow your prescriber's instructions.
Side Effects (from patient reports)
Based on 22,011 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for insulin degludec, by number of reports
- High blood sugar
High blood sugar
3,617 reports
- Feeling sick to your stomach 1,381
Feeling sick to your stomach
1,381 reports
- Low blood sugar 1,252
Low blood sugar
1,252 reports
- Throwing up 894
Throwing up
894 reports
- Low blood sugar 886
Low blood sugar
886 reports
- Diarrhea 876
Diarrhea
876 reports
- Tiredness 861
Tiredness
861 reports
- Difficulty breathing 760
Difficulty breathing
760 reports
- Falling 673
Falling
673 reports
- Feeling dizzy 652
Feeling dizzy
652 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for insulin degludec each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where insulin degludec sits
insulin degludec has more FDA adverse-event reports than 57% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is insulin degludec; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 22,011 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2011–2025.
Total Reports
22,011
Reports Mentioning Death
1,194
5.4% of reports — not proof of cause
Hospitalization Reports
6,329
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | BLOOD GLUCOSE INCREASED | 3,617 |
| 2 | NAUSEA | 1,381 |
| 3 | BLOOD GLUCOSE DECREASED | 1,252 |
| 6 | VOMITING | 894 |
| 7 | HYPOGLYCAEMIA | 886 |
| 8 | DIARRHOEA | 876 |
| 9 | FATIGUE | 861 |
| 10 | DYSPNOEA | 760 |
| 11 | FALL | 673 |
| 12 | DIZZINESS | 652 |
| 13 | HEADACHE | 634 |
| 14 | CONSTIPATION | 623 |
| 15 | MALAISE | 549 |
| 16 | GLYCOSYLATED HAEMOGLOBIN INCREASED | 545 |
| 17 | WEIGHT INCREASED | 542 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Known Drug Interactions
Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics Intervention: Dosage reductions and increased frequency of glucose monitoring may be required when XULTOPHY 100/3.6 is coadministered with these drugs.
Mechanism: Fluoxetine can increase the effect of insulin, which makes your blood sugar more likely to drop to unsafe levels.
What to do: Check your blood sugar more often and talk to your doctor about adjusting your insulin dose.
7.2 Effects of Delayed Gastric Emptying on Oral Medications Liraglutide-containing products, including XULTOPHY 100/3.6, cause a delay of gastric emptying, and thereby have the potential to impact the absorption of concomitantly administered oral medications. In clinical pharmacology trials, liraglutide did not affect the absorption of the tested orally administered medications to any clinically relevant degree [see Clinical Pharmacology ( 12.3 )] . Nonetheless, caution should be exercised when oral medications are concomitantly administered with liraglutide containing products.
Mechanism: Liraglutide slows down the movement of food and medicine through your stomach, which can change how your body absorbs pills.
What to do: Be careful when taking oral medicines with this drug and watch for changes in how well your other medicines work.
Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics Intervention: Dosage reductions and increased frequency of glucose monitoring may be required when XULTOPHY 100/3.6 is coadministered with these drugs.
Mechanism: Both drugs work to lower blood sugar, so taking them at the same time can cause your blood sugar to drop too low.
What to do: You should monitor your blood sugar levels closely and your doctor may need to lower your insulin dose.
Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics Intervention: Dosage reductions and increased frequency of glucose monitoring may be required when XULTOPHY 100/3.6 is coadministered with these drugs.
Mechanism: This medication can make your body more sensitive to insulin, which increases the risk of having low blood sugar.
What to do: Your doctor may need to lower your insulin dose, and you should check your blood sugar more frequently.
Drugs That May Decrease the Blood Glucose Lowering Effect of XULTOPHY 100/3.6 Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones.
Mechanism: Albuterol can decrease the blood-sugar-lowering effect of insulin. This can lead to higher blood sugar levels while you are using the medication.
What to do: Monitor your blood sugar levels closely if you are using albuterol. Your healthcare provider may need to adjust your insulin dose.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
What are the common side effects of insulin degludec?
Does insulin degludec interact with other medications?
What drug class is insulin degludec?
Is there a generic version of insulin degludec?
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for insulin degludec
The FDA label for insulin degludec (sold under brand names such as Tresiba) classifies it as a prescription-only medication in the Ultra-Long-Acting Insulin class. Regulatory labeling describes its approved uses and the patient populations studied in pre-market trials. Official labeling lists 6 commonly reported side effects, including Common cold, Headache, Feeling sick to your stomach.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 22,011 voluntary reports. The database also lists 12 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $11.39 versus $32.52 for the brand - a 65% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: October 14, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages