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Insulin

AEMPS

Insulins and analogues (general card; individual products require separate cards)

ATC code: A10A

Brand names: Humulin, Lantus, Toujeo

Updated · Methodology

Indications

A

Insulin-dependent type 2 diabetes mellitus

First line

Some patients with type 2 diabetes already require insulin: inadequate control on oral and non-insulin injectable agents, decompensation symptoms, marked catabolism, or severe hyperglycemia. For them, insulin is essential therapy. At earlier stages, first-line is metformin and non-insulin classes (GLP-1 agonists, SGLT2 inhibitors); clinicians add insulin when these are insufficient. Regimens: basal insulin, escalating to basal-bolus as needed.

Sources

  1. Diabetes Care: 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2024. (2024)
  2. Cochrane Database Syst Rev: Long-acting insulin analogues versus NPH insulin (human isophane insulin) for type 2 diabetes mellitus. (2007)
  3. ADA/EASD: Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association and the European Association for the Study of Diabetes (2022)
  4. Diabetologia: Management of hyperglycaemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) (2022)
  5. NICE: Type 2 diabetes in adults: management (NG28) (2022)

ICD-10: E11.9 · ICD-11: 5A11

A

Type 1 diabetes mellitus

First line

Insulin therapy is the only life-sustaining treatment for type 1 diabetes. Recommended by 2024, ISPAD 2022, ESPE, and the Russian Ministry of Health. Modern standard is basal-bolus (long-acting analogue as basal plus ultra-short before meals) or pump therapy; in children and adolescents, sensor-augmented and closed-loop systems. Target < 7% in most adults; individual targets in children, adolescents, older adults, and pregnancy.

Initial daily requirement in a newly diagnosed adult is 0.4–0.5 U/kg, higher in ketoacidosis. In children and adolescents – 0.7–1.0 U/kg during puberty. Distribute 40–50% as basal and 50–60% as boluses.

Sources

  1. Diabetes Care: 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2024. (2024)
  2. Pediatr Diabetes: ISPAD Clinical Practice Consensus Guidelines 2022: Insulin treatment in children and adolescents with diabetes. (2022)
  3. N Engl J Med: The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. (1993)

ICD-10: E10 · ICD-11: 5A10

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Muscle mass gain (bodybuilding self-use)

Not recommended

Insulin is used illicitly by bodybuilders for mass gain based on its anabolic effect via IGF-1-like action and stimulation of muscle amino-acid uptake. The effect on mass is small and the risk of fatal hypoglycaemia is high. Cases of hypoglycaemic coma and sudden death in healthy bodybuilders are reported. Hypoglycaemia is recognised late – during training or sleep. WADA lists insulin as prohibited. Using insulin in a healthy person with normal beta-cell function is Russian roulette with several rounds in the cylinder.

Sources

  1. J Emerg Med: Severe Hypoglycemia Due to Cryptic Insulin Use in a Bodybuilder. (2019)
  2. Anasthesiol Intensivmed Notfallmed Schmerzther: [Insulin as an anabolic: hypoglycemia in the bodybuilding world]. (1998)
  3. Diabetologia: Role of insulin in the regulation of human skeletal muscle protein synthesis and breakdown: a systematic review and meta-analysis. (2016)
  4. WADA Prohibited List 2026 (S4: WADA Prohibited List 2026 (S4.4 Insulins and insulin-mimetics) (2026)
How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Insulin is a hormone of pancreatic beta cells. It binds the insulin receptor and initiates a phosphorylation cascade that increases glucose uptake in muscle and adipose tissue, stimulates hepatic glycogen synthesis, and suppresses gluconeogenesis and lipolysis. Modern preparations are recombinant human insulins and analogues with modified pharmacokinetics: ultra-short (lispro, aspart, glulisine), short (regular), intermediate (NPH), long (glargine, detemir), and ultra-long (degludec). Important: this is a general card; each specific insulin will have its own card in Evigrade.

Safety

Contraindications

  • Hypersensitivity to insulin or excipients
  • Hypoglycaemia

Serious adverse effects

  • Severe hypoglycaemia with impaired consciousness, seizures, death
  • Diabetic ketoacidosis when insulin is missed in type 1 diabetes
  • Hypokalaemia during intensive therapy (insulin shifts potassium intracellularly)
  • Rare allergic reactions, both immediate and delayed

Common adverse effects

  • Hypoglycaemia (most common adverse effect)
  • Weight gain (in some patients on intensification)
  • Local injection-site reactions: lipohypertrophy, lipoatrophy, bruising

Pregnancy: can you take Insulin?

Insulin is the treatment of choice for glycaemic control in gestational diabetes and in pregnant women with type 1/2 diabetes. Human insulin and modern analogues (aspart, lispro, detemir) with confirmed pregnancy safety are used. Glargine is discussed; degludec has limited data.

Breastfeeding: can you take Insulin?

Fully compatible with breastfeeding. Insulin is digested in the infant gastrointestinal tract and does not affect the child.

Calculate RIDFull profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Patient education

Insulin therapy requires structured patient education: injection technique, carbohydrate counting, dose adjustment for glycaemia and meals, hypoglycaemia recognition and treatment, sick-day and exercise management. Without education, insulin does not work even when correctly prescribed. International standards ( Standards of Care) list structured education as a mandatory component.

Monitoring

Continuous glucose monitoring (CGM) is the current standard in patients on insulin therapy. Time-in-Range (TIR) 3.9–10.0 mmol/L ≥ 70% correlates with target and reduced complications. In children with type 1 diabetes, CGM is recommended from diagnosis. Self-monitoring of blood glucose by meter remains an important backup, especially when CGM is unavailable.

Hypoglycemia

Hypoglycaemia is the main clinically significant complication of insulin therapy. With symptoms (tremor, sweating, hunger, confusion) and glucose < 3.9 mmol/L, give 15 g of fast-acting carbohydrate (glucose tablets, juice, sugar), recheck in 15 minutes, repeat if needed. For severe hypoglycaemia with impaired consciousness – nasal glucagon (Baqsimi) or subcutaneous. Current recommendations: in insulin-treated patients at high risk of hypoglycaemia, keep glucagon at home and train family members.

Drug–drug interactions

1 pair found. Sorted from critical to minor.

ModerateCarvedilolAlpha and beta blocker (non-selective β + α1)

Mechanism

Beta-blockers mask adrenergic hypoglycaemia symptoms (tachycardia, tremor, sweating). In diabetics on insulin, the risk of severe unrecognised hypoglycaemia rises.

Symptoms

Confusion, vision changes, loss of contact, seizures. Tachycardia, tremor, and sweating are suppressed — the patient misses the hypoglycaemia.

Management

Prescribe carvedilol cautiously in diabetes. In heart failure with reduced ejection fraction, carvedilol remains first-line (improves survival) — teach the patient to recognise hypoglycaemia by any unusual sensation. On insulin, intensify glucose self-monitoring (4 times daily) for the first month. For hypertension without heart failure, alternatives: ACE inhibitor or ARB with a diuretic.

Sources

Pair details →Carvedilol →

Label mentions68 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • ModeratePioglitazone
    «Combinación de Actrapid y pioglitazona: Cuando se utilizó pioglitazona en combinación con insulina, se notificaron casos de insuficiencia cardiaca, especialmente en pacientes con factores de riesgo…»

    AEMPS, section 4.4 · Open on CIMA

  • ACE inhibitorsclass named in the label
    «DRUG INTERACTIONS: Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide…»

    FDA, section 7 · Open on DailyMed

  • anticonceptivos hormonalesclass named in the label
    «Anticonceptivos orales, tiazidas, glucocorticoides, hormonas tiroideas, simpaticomiméticos, hormona de crecimiento y danazol.»

    AEMPS, section 4.5 · Open on CIMA

  • antidiabéticos oralesclass named in the label
    «Antidiabéticos orales, inhibidores de la monoamino oxidasa (IMAO), betabloqueantes, inhibidores de la enzima conversora de la angiotensina (IECA), salicilatos, esteroides anabolizantes y sulfonamidas.»

    AEMPS, section 4.5 · Open on CIMA

  • antipsychoticsclass named in the label
    «DRUG INTERACTIONS: Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines…»

    FDA, section 7 · Open on DailyMed

  • beta blockersclass named in the label
    «DRUG INTERACTIONS: Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.»

    FDA, section 7 · Open on DailyMed

  • betabloqueantesclass named in the label
    «Antidiabéticos orales, inhibidores de la monoamino oxidasa (IMAO), betabloqueantes, inhibidores de la enzima conversora de la angiotensina (IECA), salicilatos, esteroides anabolizantes y sulfonamidas.»

    AEMPS, section 4.5 · Open on CIMA

  • Clonidine
    «DRUG INTERACTIONS: Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.»

    FDA, section 7 · Open on DailyMed

From other drugs’ labels

  • ModerateBetamethasone
    «Insulina, metformina, sulfamidas hipoglucemiantes: Elevación de la glucemia y a veces con cetosa (los corticoides disminuyen la tolerancia a los glúcidos).»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateBisoprolol
    «Combinaciones a usar con precaución: Insulina y antidiabéticos orales: Aumento del efecto hipoglucemiante. El bloqueo de los receptores beta-adrenérgicos puede enmascarar síntomas de hipoglucemia. El…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateCaptopril
    «Bloqueo dual del sistema renina-angiotensina-aldosterona (SRAA): Antidiabéticos: estudios farmacológicos han demostrado que los inhibidores de la ECA, captopril incluido, pueden potenciar los efectos…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateCarvedilol
    «Insulina y antidiabéticos orales: Se pueden ver potenciados los efectos de la insulina o de los hipoglucemiantes orales. Los signos y los síntomas de una hipoglucemia pueden estar enmascarados o…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateChlortalidone
    «También son posibles interacciones con las siguientes combinaciones: El efecto de estos medicamentos puede verse debilitado por el uso concomitante de clortalidona. Puede ser necesario ajustar la…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateCiprofloxacin
    «Disglucemia: Al igual que con otras quinolonas, se han notificado alteraciones de la glucosa en sangre, incluyendo hipoglucemia e hiperglucemia (ver sección 4.8), generalmente en pacientes diabéticos…»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateCitalopram
    «Diabetes: En pacientes diabéticos, el tratamiento con un ISRS puede alterar el control de la glucemia. Puede ser necesario ajustar la dosis de insulina y/o de los hipoglucemiantes orales.»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateCyproterone acetate
    «Diabetes: Se precisa una estricta vigilancia médica si el paciente sufre diabetes, ya que la necesidad de tomar antidiabéticos orales o insulina puede cambiar durante el tratamiento con Androcur (ver…»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateDapagliflozin
    «Cetoacidosis diabética: Los pacientes que pueden tener mayor riesgo de CAD incluyen pacientes con una baja reserva funcional de las células beta (por ej., pacientes con diabetes tipo 2 con péptido-C…»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateDexamethasone
    «Diabetes: Cuando se administra dexametasona a pacientes diabéticos, se debe tener en cuenta una mayor necesidad de insulina o antidiabéticos orales.»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateEscitalopram
    «Diabetes: En pacientes con diabetes, el tratamiento con un ISRS puede alterar el control glucémico (hipoglucemia o hiperglucemia). Puede ser necesario un ajuste de la dosis de insulina y/o de los…»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateFluoxetine
    «Diabetes: En pacientes con diabetes, el tratamiento con un ISRS puede alterar el control glucémico. Ha aparecido hipoglucemia durante el tratamiento con fluoxetina y se ha desarrollado hiperglucemia…»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateGlucosamine
    «En pacientes con tolerancia a la glucosa alterada se monitorizarán los niveles de glucosa y, cuando proceda, las necesidades de insulina antes del tratamiento y periódicamente durante el mismo.»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateHydrochlorothiazide
    «Efectos metabólicos y endocrinos: Las tiazidas pueden afectar a la tolerancia a la glucosa. En pacientes diabéticos, se requiere ajuste de dosis de insulina o medicamentos hipoglucemiantes orales…»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateLabetalol
    «Los betabloqueantes, especialmente los betabloqueantes no selectivos, pueden aumentar el riesgo de hipoglucemia en pacientes diabéticos y enmascarar los síntomas de hipoglucemia, como taquicardia y…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateLevothyroxine sodium
    «Antidiabéticos: Levotiroxina puede reducir la eficacia hipoglicemiante de los antidiabéticos (tales como metformina, glimepirida, glibenclamida así como insulina) . Por tanto, en los pacientes…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateLiraglutide
    «Liraglutida no es un sustituto de la insulina. Se ha notificado cetoacidosis diabética en pacientes insulinodependientes después de una interrupción rápida o reducción de la dosis de insulina (ver…»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateLisinopril
    «Antidiabéticos: En pacientes diabéticos tratados con agentes antidiabéticos orales o insulina, deberá vigilarse estrechamente el control glucémico por casos de hipoglucemia, especialmente durante el…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateMirtazapine
    «Situaciones que necesitan supervisión: diabetes mellitus: los antidepresivos pueden alterar el control de la glucemia en pacientes diabéticos. Puede ser necesario ajustar las dosis de insulina y/o…»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateMoxifloxacin
    «Disglucemia: Al igual que con todas las fluoroquinolonas, se han reportado alteraciones en la glucosa sanguínea, incluyendo tanto hipoglucemia e hiperglucemia con moxifloxacino (ver sección 4.8). En…»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateParoxetine
    «Pravastatina: Se ha observado una interacción entre paroxetina y pravastatina en estudios que sugiere que la co- administración de paroxetina y pravastatina puede ocasionar un aumento de los niveles…»

    AEMPS, section 4.5 · Open on CIMA

  • ModeratePioglitazone
    «Retención hídrica e insuficiencia cardiaca: La pioglitazona puede producir retención hídrica de fluidos; esto puede exacerbar o precipitar la insuficiencia cardiaca. Cuando se traten pacientes que…»

    AEMPS, section 4.4 · Open on CIMA

  • ModeratePropranolol
    «Puede bloquear o modificar los signos y síntomas de hipoglucemia (especialmente taquicardia). En ocasiones, propranolol provoca hipoglucemia, incluso en pacientes no diabéticos, p. ej.,neonatos…»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateRamipril
    «Agentes antidiabéticos, incluida la insulina: Pueden producirse reacciones de hipoglucemia. Se recomienda la determinación periódica de la glucemia.»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateSemaglutide
    «General: No se debe utilizar semaglutida para el tratamiento de la cetoacidosis diabética. Semaglutida no es un sustituto de la insulina. Se ha notificado cetoacidosis diabética en pacientes…»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateSertraline
    «Diabetes: En pacientes con diabetes, el tratamiento con un ISRS puede alterar el control glucémico. Puede ser necesario el ajuste de dosis de insulina y/ o del hipoglucemiante oral.»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateSotalol
    «Insulina e hipoglucemiantes orales: Puede desarrollarse hiperglucemia, y puede ser necesario ajustar la dosis de los antidiabéticos orales. Los betabloqueantes pueden enmascarar síntomas de…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateTelmisartan
    «Pacientes diabéticos tratados con insulina o antidiabéticos: En estos pacientes puede aparecer hipoglucemia bajo tratamiento con telmisartán. Por lo tanto, en estos pacientes se debe considerar una…»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateTirzepatide
    «Hipoglucemia: Los pacientes que reciben tirzepatida en combinación con un secretagogo de insulina (por ejemplo, una sulfonilurea) o insulina pueden tener un mayor riesgo de hipoglucemia. El riesgo de…»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateTranylcypromine
    «Influencia en el efecto de otros medicamentos: Puede potenciarse el efecto de insulina y de antidiabéticos orales. Puede ser necesario un ajuste de dosis (ver también sección 4.4).»

    AEMPS, section 4.5 · Open on CIMA

  • MinorDorzolamide
    «- fármacos sistémicos, incluidos los inhibidores de la ECA, bloqueadores de los canales de calcio, diuréticos, fármacos antiinflamatorios no esteroideos (incluido el ácido acetilsalicílico), y…»

    AEMPS, section 4.5 · Open on CIMA

  • Acetylsalicylic acid
    «Antidiabéticos como insulina y sulfonilureas en combinación con ácido acetilsalicílico a dosis más altas : la administración concomitante del ácido acetilsalicílico a dosis más altas con insulina y…»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Insulin used for?

Insulin is evaluated for the following indications with varying evidence strength: Insulin-dependent type 2 diabetes mellitus (evidence tier A), Type 1 diabetes mellitus (evidence tier A), Muscle mass gain (bodybuilding self-use) (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Insulin?

Common side effects of Insulin (≥ 1 in 100): Hypoglycaemia (most common adverse effect), Weight gain (in some patients on intensification), Local injection-site reactions: lipohypertrophy, lipoatrophy, bruising. See the Safety section for uncommon and serious reactions.

Is Insulin safe during pregnancy?

Insulin is the treatment of choice for glycaemic control in gestational diabetes and in pregnant women with type 1/2 diabetes. Human insulin and modern analogues (aspart, lispro, detemir) with confirmed pregnancy safety are used. Glargine is discussed; degludec has limited data.

Is Insulin compatible with breastfeeding?

Fully compatible with breastfeeding. Insulin is digested in the infant gastrointestinal tract and does not affect the child.

Who should not take Insulin?

Insulin is contraindicated in: Hypersensitivity to insulin or excipients; Hypoglycaemia. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Insulin aspart, Insulin degludec, Insulin detemir, Insulin glargine, Liraglutide, Sitagliptin, Dapagliflozin, Insulin glulisine