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Levemir Side Effects

Common Levemir Side Effects


The most commonly reported Levemir side effects (click to view or check a box to report):

Blood Glucose Increased (1010)
Hypoglycaemia (176)
Injection Site Erythema (131)
Blood Glucose Decreased (125)
Blood Glucose Fluctuation (117)
Injection Site Pruritus (99)
Injection Site Pain (98)
Nausea (73)
Injection Site Haemorrhage (73)
Injection Site Mass (69)
Dizziness (63)
Injection Site Bruising (61)
Hyperglycaemia (60)
Injection Site Haematoma (58)
Diabetes Mellitus Inadequate Control (58)
Pruritus (56)
Injection Site Swelling (52)
Headache (48)
Rash (47)
Weight Increased (47)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Levemir Side Effects Reported to FDA

The following Levemir reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Levemir on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Abdominal Mass, Local Swelling, Thrombosis, Injection Site Bruising
This is a report of a 82-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: type 2 diabetes mellitus, who was treated with Levemir Flexpen (dosage: 37 Units, Qd, start time: NS), combined with:
  • Novolog Flexpen (Sliding Scale Tid)
  • Atorvastatin (10 Mg, Qd)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Abdominal Mass
  • Local Swelling
  • Thrombosis
  • Injection Site Bruising
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Levemir Flexpen treatment in female patients, resulting in abdominal mass side effect. The patient was hospitalized.

Respiratory Disorder Neonatal, Jaundice Neonatal, Foetal Exposure During Pregnancy, Exposure During Breast Feeding
This report suggests a potential Levemir Flexpen Respiratory Disorder Neonatal, Jaundice Neonatal, Foetal Exposure During Pregnancy, Exposure During Breast Feeding side effect(s) that can have serious consequences. A female patient (weight: NA) from TR was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Levemir Flexpen (dosage: 16 U, Qd) starting 201305. Soon after starting Levemir Flexpen the patient began experiencing various side effects, including:
  • Respiratory Disorder Neonatal
  • Jaundice Neonatal
  • Foetal Exposure During Pregnancy
  • Exposure During Breast Feeding
Drugs used concurrently: NA.The patient was hospitalized. Although Levemir Flexpen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as respiratory disorder neonatal, may still occur.

Thrombosis, Weight Increased
This Thrombosis, Weight Increased problem was reported by a consumer or non-health professional from US. A 81-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: diabetes mellitus,thrombosis. On 1995 this consumer started treatment with Levemir (dosage: 8 Units). The following drugs were being taken at the same time:
  • Xarelto (20mg Once Daily)
  • Metformin (2000 Mg, Qd)
  • Levothyroxine (137 Ug, Qd)
  • Glyburide (10 Mg, Qd)
When commencing Levemir, the patient experienced the following unwanted symptoms/side effects:
  • Thrombosis
  • Weight Increased
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as thrombosis, may become evident only after a product is in use by the general population.

Liver Disorder, Enterocolitis
This is a report of a 69-year-old female patient (weight: NA) from JP. The patient developed the following symptoms/conditions: type 2 diabetes mellitus and was treated with Levemir Chu (dosage: Unk) starting 201201. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Liver Disorder
  • Enterocolitis
The patient was hospitalized. This opens a possibility that Levemir Chu treatment could cause the above reactions, including liver disorder, and some female subjects may be more susceptible.


Hypoglycaemic Unconsciousness
A 71-year-old male patient (weight: NA) from US with the following symptoms/conditions: type 1 diabetes mellitus started Levemir treatment (dosage: 31 U, Qd In Am, Subcutaneous) on 2004. Soon after starting Levemir treatment, the subject experienced various side effects, including:
  • Hypoglycaemic Unconsciousness
Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Levemir.

Blood Glucose Increased
A 90-year-old female patient from US (weight: NA) experienced symptoms, such as: type 2 diabetes mellitus and was treated with Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l(dosage: NA). The treatment was initiated on 201201. After that a consumer reported the following side effect(s):
  • Blood Glucose Increased
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l efficacy: NA.The patient was hospitalized.

Blood Glucose Decreased
In this report, Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l was administered for the following condition: type 2 diabetes mellitus.A 69-year-old female consumer from US (weight: NA) started Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l treatment (dosage: 50, Subcutaneous) on Dec 12, 2011.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Blood Glucose Decreased
A possible interaction with other drugs could have contributed to this reaction:
  • Gabapentin (gabapentin)
  • Metformin (metformin)
The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l treatment could be related to the listed above side effect(s).

Hyperglycaemic Unconsciousness
This is a report of the following Levemir side effect(s):
  • Hyperglycaemic Unconsciousness
A 62-year-old female patient from US (weight: NA) presented with the following condition: type 2 diabetes mellitus and received a treatment with Levemir (dosage: NA) starting: 2010.The following concurrently used drugs could have generated interactions:
  • Humalog (insulin Lispro)
  • Amlodipine (amlodipine)
  • Lyrica (pregabalin)
This report suggests that a Levemir treatment could be associated with the listed above side effect(s).

Hypoglycaemic Unconsciousness
This Levemir (insulin Detemir) Solution For Injection, .0024mol/l report was submitted by a 78-year-old female consumer from US (weight: NA). The patient was diagnosed with: type 2 diabetes mellitus and Levemir (insulin Detemir) Solution For Injection, .0024mol/l was administered (dosage: 30 U, Qd, Subcutaneous?) starting: 2005. The consumer developed a set of symptoms:
  • Hypoglycaemic Unconsciousness
Other drugs used simultaneously:
  • Glyburide (glibenclamide)
Those unexpected symptoms could be linked to a Levemir (insulin Detemir) Solution For Injection, .0024mol/l treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Hypoglycaemic Unconsciousness, Shock Hypoglycaemic, Tinnitus, Hyperhidrosis, Urinary Incontinence, Blood Glucose Increased
This is a report of a possible correlation between Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l use and the following symptoms/side effect(s):
  • Hypoglycaemic Unconsciousness
  • Shock Hypoglycaemic
  • Tinnitus
  • Hyperhidrosis
  • Urinary Incontinence
  • Blood Glucose Increased
which could contribute to an assessment of Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l risk profile.A 77-year-old female consumer from US (weight: NA) was suffering from type 2 diabetes mellitus and was treated with Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l (dosage: NA) starting 2009.Other concurrent medications:
  • Glibenase (glipizide)


Blood Glucose Decreased
A 56-year-old female patient from US (weight: NA) presented with the following symptoms: type 1 diabetes mellitus and after a treatment with Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l (dosage: NA) experienced the following side effect(s):
  • Blood Glucose Decreased
The treatment was started on NS. Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l was used in combination with the following drugs: NA.This report could alert potential Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l consumers.

Accidental Overdose, Blood Glucose Abnormal
In this report, a 65-year-old male patient from US (weight: NA) was affected by a possible Levemir (insulin Detemir) Solution For Injection, .0024mol/l side effect.The patient was diagnosed with type 2 diabetes mellitus. After a treatment with Levemir (insulin Detemir) Solution For Injection, .0024mol/l (dosage: 1000 U, Single, start date: Sep 16, 2013), the patient experienced the following side effect(s):
  • Accidental Overdose
  • Blood Glucose Abnormal
The following simultaneously used drugs could have led to this reaction:
  • Novolog (insulin Aspart)
The findings here stress that side effects should be taken into consideration when evaluating a Levemir (insulin Detemir) Solution For Injection, .0024mol/l treatment.

Blood Glucose Abnormal
This is a report of a 49-year-old female patient from US (weight: NA), who used Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l (dosage: NA) for a treatment of NA. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Blood Glucose Abnormal
The following drugs could possibly have interacted with the Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l treatment NA.Taken together, these observations suggest that a Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l treatment could be related to side effect(s), such as Blood Glucose Abnormal.

Blood Glucose Decreased
This blood glucose decreased side effect was reported by a pharmacist from US. A 66-year-old female patient (weight:NA) experienced the following symptoms/conditions: insulin-requiring type 2 diabetes mellitus. The patient was prescribed Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l (dosage: NA), which was started on NS. Concurrently used drugs: NA. When starting to take Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l the consumer reported the following symptoms:
  • Blood Glucose Decreased
These side effects may potentially be related to Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l.

Anaphylactic Reaction
This is a Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l side effect report of a 40-year-old female patient (weight:NA) from US, suffering from the following symptoms/conditions: type 2 diabetes mellitus, who was treated with Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l (dosage:40 U, Bid, Subcutaneous, start time: 201304), combined with:
  • Lisinopril And Hydrochlorothiazide (hydrochlorothiazide, Lisinopril)
, and developed a serious reaction and a anaphylactic reaction side effect. The patient presented with:
  • Anaphylactic Reaction
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l treatment in female patients suffering from type 2 diabetes mellitus, resulting in anaphylactic reaction.

Urticaria
This report suggests a potential Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l urticaria side effect(s) that can have serious consequences. A 71-year-old female patient from US (weight:NA) was diagnosed with the following health condition(s): type 2 diabetes mellitus and used Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l (dosage: NA) starting 2007. Soon after starting Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l the patient began experiencing various side effects, including:
  • Urticaria
Drugs used concurrently:NA. Although Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as urticaria, may still occur.

Blood Glucose Decreased
This blood glucose decreased problem was reported by a consumer or non-health professional from US. A 47-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): type 2 diabetes mellitus.On 201302 a consumer started treatment with Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l (dosage: 60 Units Every Night At Bedtime, Subcutaneous). The following drugs/medications were being taken at the same time:
  • Novolog Flexpen (insulin Aspart) Solution For Injection, 100u/ml (Sliding Scale, About 10 5 Units Three Times Daily, Subcutaneous)
When commencing Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l, the patient experienced the following unwanted symptoms /side effects:
  • Blood Glucose Decreased
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as blood glucose decreased, may become evident only after a product is in use by the general population.

Blood Glucose Decreased, Blood Glucose Fluctuation, Diabetes Mellitus Inadequate Control
This is a Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l side effect report of a 62-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: latent autoimmune diabetes in adults and was treated with Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l (dosage: NA) starting 201210. Concurrently used drugs:
  • Novolog Flexpen (insulin Aspart) Solution For Injection, 100u/ml (Sliding Scale, Subcutaneous)
Soon after that, the consumer experienced the following of symptoms:
  • Blood Glucose Decreased
  • Blood Glucose Fluctuation
  • Diabetes Mellitus Inadequate Control
The patient was hospitalized. This opens a possibility that Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l could cause blood glucose decreased and that some female patients may be more susceptible.

Hypoglycaemic Seizure, Blood Glucose Decreased
A 87-year-old female patient (weight: NA) from US with the following symptoms: NA started Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l treatment (dosage: NA) on NS. Soon after starting Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l treatment, the consumer experienced several side effects, including:
  • Hypoglycaemic Seizure
  • Blood Glucose Decreased
. Concurrently used drugs: NA. This finding indicates that some patients can be more vulnerable to developing Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l side effects, such as hypoglycaemic seizure.

Device Breakage, Hyperglycaemic Seizure
This device breakage side effect was reported by a consumer or non-health professional from US. A 65-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 1 diabetes mellitus.The patient was prescribed Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l (dosage: NA), which was started on 201303. Concurrently used drugs: NA..When starting to take Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l the consumer reported symptoms, such as:
  • Device Breakage
  • Hyperglycaemic Seizure
These side effects may potentially be related to Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l. The patient was hospitalized.

Diabetic Ketoacidosis
This is a report of a 75-year-old male patient (weight: NA) from US, suffering from the following symptoms/conditions: type 2 diabetes mellitus, who was treated with Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l (dosage: NA, start time: 2012), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Diabetic Ketoacidosis
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l treatment in male patients, resulting in diabetic ketoacidosis side effect. The patient was hospitalized.

Anaphylactic Reaction
This report suggests a potential Levemir (insulin Detemir) Solution For Injection, .0024mol/l Anaphylactic Reaction side effect(s) that can have serious consequences. A 44-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: type 1 diabetes mellitus and used Levemir (insulin Detemir) Solution For Injection, .0024mol/l (dosage: NA) starting 2010. Soon after starting Levemir (insulin Detemir) Solution For Injection, .0024mol/l the patient began experiencing various side effects, including:
  • Anaphylactic Reaction
Drugs used concurrently:
  • Synthroid (levothyroxine Sodium)
Although Levemir (insulin Detemir) Solution For Injection, .0024mol/l demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as anaphylactic reaction, may still occur.

Blood Glucose Increased
This Blood Glucose Increased problem was reported by a consumer or non-health professional from US. A 76-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On NS this consumer started treatment with Levemir (insulin Detemir) Solution For Injection, .0024mol/l (dosage: NA). The following drugs were being taken at the same time: NA. When commencing Levemir (insulin Detemir) Solution For Injection, .0024mol/l, the patient experienced the following unwanted symptoms/side effects:
  • Blood Glucose Increased
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as blood glucose increased, may become evident only after a product is in use by the general population.

Blood Glucose Increased
This is a report of a 21-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: blood glucose increased and was treated with Levemir (dosage: 20 U, Qd, Subcutaneous?) starting 201301. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Blood Glucose Increased
This opens a possibility that Levemir treatment could cause the above reactions, including blood glucose increased, and some male subjects may be more susceptible.

Blood Glucose Increased, Hypertension, Pneumonia
A 57-year-old female patient (weight: NA) from US with the following symptoms/conditions: type 2 diabetes mellitus started Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l treatment (dosage: NA) on 2012. Soon after starting Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l treatment, the subject experienced various side effects, including:
  • Blood Glucose Increased
  • Hypertension
  • Pneumonia
Concurrently used drugs:
  • Glumetza (metformin Hydrochloride)
  • Lisinopril/hctz (hydrochlorothiazide, Lisinopril)
  • Januvia (sitagliptin Phosphate)
This finding indicates that some female patients could be more vulnerable to Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


    Discuss Levemir Side Effects

    Did You Have a Levemir Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Levemir for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Levemir Safety Alerts, Active Ingredients, Usage Information

    NDC0169-3687
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameLevemir
    Nameinsulin detemir
    Dosage FormINJECTION, SOLUTION
    RouteSUBCUTANEOUS
    On market since20060327
    LabelerNovo Nordisk
    Active Ingredient(s)INSULIN DETEMIR
    Strength(s)100
    Unit(s)[iU]/mL
    Pharma ClassInsulin [Chemical/Ingredient],Insulin Analog [EPC]

    Levemir Dosage, Warnings, Usage.

    Side Effects reported to FDA: 3166

    Levemir safety alerts: 2009

    Reported deaths: 171

    Reported hospitalizations: 790

    Levemir Insulin (Novo Nordisk)

    Audience: Patients, pharmacists, diabetes healthcare professionals

    [UPDATED 08/26/2009]  FDA is reminding the public that stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. still may be on the market. Evidence gathered to date suggests that the stolen insulin was not stored and handled properly and may be dangerous for people to use. FDA has received multiple reports of patients who suffered an adverse event due to poor control of glucose levels after using a vial from one of the stolen lots.

    [Posted 06/13/2009] FDA notified patients and healthcare professionals that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. are being sold in the U.S. market, may not have been stored and handled properly, and may be dangerous for patients to use. The agency is advising patients who use Levemir insulin to:

    • Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036, XZF0037, and XZF0038. 
    • Do not use your Levemir insulin if it is from one of these lots.
    • Always visually inspect your insulin before using it. Levemir is a clear and colorless solution.
    • Contact the Novo Nordisk Customer Care Center at 1-800-727-6500 for what to do with vials from these lots or if you have any other questions.

    [08/26/2009 - News Release- FDA]
    [08/04/2009 - Patient Safety News video - FDA YouTube Channel]
    [06/13/2009 - News Release - FDA]

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