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Levemir Side Effects

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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.

Levemir Side Effects Reported to FDA



Levemir Side Effect Report#9995738
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 health 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): Abdominal Mass, Local Swelling, Thrombosis, Injection Site Bruising 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.
Levemir Side Effect Report#9989364
Respiratory Disorder Neonatal, Jaundice Neonatal, Foetal Exposure During Pregnancy, Exposure During Breast Feeding
This report suggests a potential Levemir Flexpen Respiratory Disorder Neonatal 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. After starting Levemir Flexpen the patient began experiencing various side effects, including: Respiratory Disorder Neonatal, Jaundice Neonatal, Foetal Exposure During Pregnancy, Exposure During Breast FeedingAdditional 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.
Levemir Side Effect Report#9972228
Thrombosis, Weight Increased
This Thrombosis 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 using Levemir, the patient experienced the following unwanted symptoms/side effects: Thrombosis, Weight IncreasedAlthough 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.
Levemir Side Effect Report#9949011
Liver Disorder, Enterocolitis
This Liver Disorder side effect was reported by a physician from JP. A 69-year-old female patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Levemir Chu (drug dosage: Unk), which was initiated on 201201. Concurrently used drugs: NA..After starting to take Levemir Chu the consumer reported adverse symptoms, such as: Liver Disorder, EnterocolitisThese side effects may potentially be related to Levemir Chu. The patient was hospitalized.
Levemir Side Effect Report#9936808
Hypoglycaemic Unconsciousness
This is a report of a 71-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: type 1 diabetes mellitus, who was treated with Levemir (dosage: 31 U, Qd In Am, Subcutaneous, start time: 2004), combined with: NA. and developed a serious reaction and side effect(s): Hypoglycaemic Unconsciousness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Levemir treatment in male patients, resulting in Hypoglycaemic Unconsciousness side effect. The patient was hospitalized.
Levemir Side Effect Report#9936807
Blood Glucose Increased
This report suggests a potential Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l Blood Glucose Increased side effect(s) that can have serious consequences. A 90-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l (dosage: NA) starting 201201. After starting Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l the patient began experiencing various side effects, including: Blood Glucose IncreasedAdditional drugs used concurrently: NA.The patient was hospitalized. Although Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Glucose Increased, may still occur.
Levemir Side Effect Report#9936806
Blood Glucose Decreased
This Blood Glucose Decreased problem was reported by a consumer or non-health professional from US. A 69-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On
Dec 12, 2011 this consumer started treatment with Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l (dosage: 50, Subcutaneous). The following drugs were being taken at the same time:
  • Gabapentin (gabapentin)
  • Metformin (metformin)
When using Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l, the patient experienced the following unwanted symptoms/side effects: Blood Glucose DecreasedThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry 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.
Levemir Side Effect Report#9936805
Hyperglycaemic Unconsciousness
This Hyperglycaemic Unconsciousness side effect was reported by a consumer or non-health professional from US. A 62-year-old female patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Levemir (drug dosage: NA), which was initiated on 2010. Concurrently used drugs:
  • Humalog (insulin Lispro)
  • Amlodipine (amlodipine)
  • Lyrica (pregabalin)
.After starting to take Levemir the consumer reported adverse symptoms, such as: Hyperglycaemic UnconsciousnessThese side effects may potentially be related to Levemir.
Levemir Side Effect Report#9936804
Hypoglycaemic Unconsciousness
This is a report of a 78-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Levemir (insulin Detemir) Solution For Injection, .0024mol/l (dosage: 30 U, Qd, Subcutaneous?, start time: 2005), combined with:
  • Glyburide (glibenclamide)
and developed a serious reaction and side effect(s): Hypoglycaemic Unconsciousness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Levemir (insulin Detemir) Solution For Injection, .0024mol/l treatment in female patients, resulting in Hypoglycaemic Unconsciousness side effect.
Levemir Side Effect Report#9936803
Hypoglycaemic Unconsciousness, Shock Hypoglycaemic, Tinnitus, Hyperhidrosis, Urinary Incontinence, Blood Glucose Increased
This report suggests a potential Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l Hypoglycaemic Unconsciousness side effect(s) that can have serious consequences. A 77-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l (dosage: NA) starting 2009. After starting Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l the patient began experiencing various side effects, including: Hypoglycaemic Unconsciousness, Shock Hypoglycaemic, Tinnitus, Hyperhidrosis, Urinary Incontinence, Blood Glucose IncreasedAdditional drugs used concurrently:
  • Glibenase (glipizide)
Although Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypoglycaemic Unconsciousness, may still occur.
Levemir Side Effect Report#9936802
Blood Glucose Decreased
This Blood Glucose Decreased problem was reported by a pharmacist from US. A 56-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: type 1 diabetes mellitus. On NS this consumer started treatment with Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l (dosage: NA). The following drugs were being taken at the same time: NA. When using Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l, the patient experienced the following unwanted symptoms/side effects: Blood Glucose DecreasedAlthough all drugs are carefully tested before they are licensed for use, they carry 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.
Levemir Side Effect Report#9936801
Accidental Overdose, Blood Glucose Abnormal
This Accidental Overdose side effect was reported by a pharmacist from US. A 65-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Levemir (insulin Detemir) Solution For Injection, .0024mol/l (drug dosage: 1000 U, Single), which was initiated on
Sep 16, 2013. Concurrently used drugs:
  • Novolog (insulin Aspart)
.After starting to take Levemir (insulin Detemir) Solution For Injection, .0024mol/l the consumer reported adverse symptoms, such as: Accidental Overdose, Blood Glucose AbnormalThese side effects may potentially be related to Levemir (insulin Detemir) Solution For Injection, .0024mol/l.
Levemir Side Effect Report#9936799
Blood Glucose Abnormal
This is a report of a 49-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Blood Glucose Abnormal 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 female patients, resulting in Blood Glucose Abnormal side effect.
Levemir Side Effect Report#9936797
Blood Glucose Decreased
This report suggests a potential Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l Blood Glucose Decreased side effect(s) that can have serious consequences. A 66-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: insulin-requiring type 2 diabetes mellitus and used Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l (dosage: NA) starting NS. After starting Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l the patient began experiencing various side effects, including: Blood Glucose DecreasedAdditional 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 Blood Glucose Decreased, may still occur.
Levemir Side Effect Report#9936796
Anaphylactic Reaction
This Anaphylactic Reaction problem was reported by a physician from US. A 40-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On 201304 this consumer started treatment with Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l (dosage: 40 U, Bid, Subcutaneous). The following drugs were being taken at the same time:
  • Lisinopril And Hydrochlorothiazide (hydrochlorothiazide, Lisinopril)
When using Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l, the patient experienced the following unwanted symptoms/side effects: Anaphylactic ReactionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Anaphylactic Reaction, may become evident only after a product is in use by the general population.
Levemir Side Effect Report#9936795
Urticaria
This Urticaria side effect was reported by a pharmacist from US. A 71-year-old female patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l (drug dosage: NA), which was initiated on 2007. Concurrently used drugs: NA..After starting to take Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l the consumer reported adverse symptoms, such as: UrticariaThese side effects may potentially be related to Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l.
Levemir Side Effect Report#9936794
Blood Glucose Decreased
This is a report of a 47-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l (dosage: 60 Units Every Night At Bedtime, Subcutaneous, start time: 201302), combined with:
  • Novolog Flexpen (insulin Aspart) Solution For Injection, 100u/ml (Sliding Scale, About 10 5 Units Three Times Daily, Subcutaneous)
and developed a serious reaction and side effect(s): Blood Glucose Decreased 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 Blood Glucose Decreased side effect.
Levemir Side Effect Report#9936793
Blood Glucose Decreased, Blood Glucose Fluctuation, Diabetes Mellitus Inadequate Control
This report suggests a potential Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l Blood Glucose Decreased side effect(s) that can have serious consequences. A 62-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: latent autoimmune diabetes in adults and used Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l (dosage: NA) starting 201210. After starting Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l the patient began experiencing various side effects, including: Blood Glucose Decreased, Blood Glucose Fluctuation, Diabetes Mellitus Inadequate ControlAdditional drugs used concurrently:
  • Novolog Flexpen (insulin Aspart) Solution For Injection, 100u/ml (Sliding Scale, Subcutaneous)
The patient was hospitalized. Although Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Glucose Decreased, may still occur.
Levemir Side Effect Report#9936792
Hypoglycaemic Seizure, Blood Glucose Decreased
This Hypoglycaemic Seizure problem was reported by a consumer or non-health professional from US. A 87-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l (dosage: NA). The following drugs were being taken at the same time: NA. When using Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l, the patient experienced the following unwanted symptoms/side effects: Hypoglycaemic Seizure, Blood Glucose DecreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypoglycaemic Seizure, may become evident only after a product is in use by the general population.
Levemir Side Effect Report#9936791
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 (drug dosage: NA), which was initiated on 201303. Concurrently used drugs: NA..After starting to take Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l the consumer reported adverse symptoms, such as: Device Breakage, Hyperglycaemic SeizureThese side effects may potentially be related to Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l. The patient was hospitalized.
Levemir Side Effect Report#9936789
Diabetic Ketoacidosis
This is a report of a 75-year-old male patient (weight: NA) from US, suffering from the following health 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): Diabetic Ketoacidosis 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.
Levemir Side Effect Report#9936788
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. After starting Levemir (insulin Detemir) Solution For Injection, .0024mol/l the patient began experiencing various side effects, including: Anaphylactic ReactionAdditional 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.
Levemir Side Effect Report#9936787
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 using Levemir (insulin Detemir) Solution For Injection, .0024mol/l, the patient experienced the following unwanted symptoms/side effects: Blood Glucose IncreasedAlthough 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.
Levemir Side Effect Report#9936786
Blood Glucose Increased
This Blood Glucose Increased side effect was reported by a health professional from US. A 21-year-old male patient (weight:NA) experienced the following symptoms/conditions: blood glucose increased.The patient was prescribed Levemir (drug dosage: 20 U, Qd, Subcutaneous?), which was initiated on 201301. Concurrently used drugs: NA..After starting to take Levemir the consumer reported adverse symptoms, such as: Blood Glucose IncreasedThese side effects may potentially be related to Levemir.
Levemir Side Effect Report#9936783
Blood Glucose Increased, Hypertension, Pneumonia
This is a report of a 57-year-old female patient (weight: NA) from US, suffering from the following health 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:
  • Glumetza (metformin Hydrochloride)
  • Lisinopril/hctz (hydrochlorothiazide, Lisinopril)
  • Januvia (sitagliptin Phosphate)
and developed a serious reaction and side effect(s): Blood Glucose Increased, Hypertension, Pneumonia 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 female patients, resulting in Blood Glucose Increased side effect.

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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.


Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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.

    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.

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    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]

    Latest Levemir clinical trials