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Novorapid Side Effects

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Common Novorapid Side Effects


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

Hypoglycaemia (228)
Blood Glucose Increased (99)
Diabetes Mellitus Inadequate Control (94)
Hyperglycaemia (89)
Anti-insulin Antibody Positive (63)
Blood Glucose Fluctuation (55)
Suicide Attempt (50)
Anti-insulin Antibody Increased (45)
Intentional Overdose (44)
Hypoglycaemic Coma (44)
Anti-insulin Antibody (39)
Loss Of Consciousness (36)
Hepatic Function Abnormal (35)
Diabetic Ketoacidosis (34)
Premature Baby (31)
Malaise (29)
Alanine Aminotransferase Increased (27)
Aspartate Aminotransferase Increased (26)
Vomiting (26)
Dyspnoea (26)

➢ 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.

Novorapid Side Effects Reported to FDA



Novorapid Side Effect Report#9938707
Hypertension, Blood Glucose Abnormal, Exposure During Pregnancy
This is a report of a 31-year-old female patient (weight: NA) from TR, suffering from the following health symptoms/conditions: gestational diabetes, who was treated with Novorapid Flexpen (dosage: 38 U, Qd, start time:
Jan 23, 2014), combined with:
  • Levemir Flexpen (32 U, Qd)
  • Estrofem (1 Tab, Tid)
  • Folidoce (1 Df, Qd (1x1))
and developed a serious reaction and side effect(s): Hypertension, Blood Glucose Abnormal, Exposure During Pregnancy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Novorapid Flexpen treatment in female patients, resulting in Hypertension side effect. The patient was hospitalized.
Novorapid Side Effect Report#9922146
Hospitalisation, Off Label Use
This report suggests a potential Novorapid Flexpen Hospitalisation side effect(s) that can have serious consequences. A 22-year-old male patient (weight: NA) from ZA was diagnosed with the following symptoms/conditions: NA and used Novorapid Flexpen (dosage: Unk) starting NS. After starting Novorapid Flexpen the patient began experiencing various side effects, including: Hospitalisation, Off Label UseAdditional drugs used concurrently: NA.The patient was hospitalized. Although Novorapid Flexpen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hospitalisation, may still occur.
Novorapid Side Effect Report#9919300
Abortion Spontaneous, Exposure During Pregnancy
This Abortion Spontaneous problem was reported by a consumer or non-health professional from TR. A 33-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On
May 03, 2013 this consumer started treatment with Novorapid Flexpen (dosage: 24 U, Qd). The following drugs were being taken at the same time:
  • Insulatard Hm Penfill (10 U, Qd)
  • Folbiol (5 Mg, Qd)
When using Novorapid Flexpen, the patient experienced the following unwanted symptoms/side effects: Abortion Spontaneous, Exposure During PregnancyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abortion Spontaneous, may become evident only after a product is in use by the general population.
Novorapid Side Effect Report#9916514
Preterm Premature Rupture Of Membranes, Premature Delivery, Exposure During Pregnancy
This Preterm Premature Rupture Of Membranes side effect was reported by a physician from JP. A 32-year-old female patient (weight:NA) experienced the following symptoms/conditions: gestational diabetes.The patient was prescribed Novorapid Chu (drug dosage: 3 U, Tid (3 Units Before Each Meal)), which was initiated on 201307. Concurrently used drugs: NA..After starting to take Novorapid Chu the consumer reported adverse symptoms, such as: Preterm Premature Rupture Of Membranes, Premature Delivery, Exposure During PregnancyThese side effects may potentially be related to Novorapid Chu.
Novorapid Side Effect Report#9913867
Convulsion, Convulsion
This is a report of a 17-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: type 1 diabetes mellitus, who was treated with Novorapid Flexpen (dosage: Unk, start time: NS), combined with:
  • Lamotrigine (Unk)
  • Gabapentin (Unk)
  • Midazolam (Unk)
and developed a serious reaction and side effect(s): Convulsion, Convulsion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Novorapid Flexpen treatment in male patients, resulting in Convulsion side effect.
Novorapid Side Effect Report#9901436
Hypokalaemia
This report suggests a potential Novorapid Flexpen Hypokalaemia side effect(s) that can have serious consequences. A 57-year-old male patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: diabetes mellitus,hypertension and used Novorapid Flexpen (dosage: 29 U, Qd) starting
Jan 01, 2013. After starting Novorapid Flexpen the patient began experiencing various side effects, including: HypokalaemiaAdditional drugs used concurrently:
  • Lasix /00032601/ (25 Mg, Qd)
  • Lantus (14 U, Qd)
  • Peptazol /01159001/
  • Tapazole
  • Ticlopidina
  • Adalat
  • Unipril /00574902/
  • Kanrenol
The patient was hospitalized. Although Novorapid Flexpen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypokalaemia, may still occur.
Novorapid Side Effect Report#9901434
Sepsis, Diabetic Ketoacidosis, Malaise, Hypoglycaemia, Hypoglycaemia, Diabetes Mellitus Inadequate Control, Blood Glucose Increased
This Sepsis problem was reported by a consumer or non-health professional from GB. A 74-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On
Jan 02, 2014 this consumer started treatment with Novorapid Flexpen (dosage: 6 U, Tid ( 8am / 12pm / 8pm )). The following drugs were being taken at the same time: NA. When using Novorapid Flexpen, the patient experienced the following unwanted symptoms/side effects: Sepsis, Diabetic Ketoacidosis, Malaise, Hypoglycaemia, Hypoglycaemia, Diabetes Mellitus Inadequate Control, Blood Glucose IncreasedThe 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 Sepsis, may become evident only after a product is in use by the general population.
Novorapid Side Effect Report#9880977
Subdural Haematoma, Hypoglycaemia
This Subdural Haematoma side effect was reported by a health professional from FR. A 75-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Novorapid (drug dosage: Unk (6-8 Iu In The Morning And 8-12 Iu At Noon)), which was initiated on NS. Concurrently used drugs:
  • Lantus (20 Iu, Qd (evening))
.After starting to take Novorapid the consumer reported adverse symptoms, such as: Subdural Haematoma, HypoglycaemiaThese side effects may potentially be related to Novorapid. The patient was hospitalized.
Novorapid Side Effect Report#9880974
Haemolytic Anaemia
This is a report of a 50-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Novorapid (dosage: Unk, start time: 201306), combined with:
  • Prograf (Unk)
  • Rovalcyte (Unk)
  • Inexium /01479302/ (80 Mg, Qd)
  • Prednisone (Unk)
  • Cellcept /01275102/ (Unk)
  • Neoral (Unk)
and developed a serious reaction and side effect(s): Haemolytic Anaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Novorapid treatment in male patients, resulting in Haemolytic Anaemia side effect. The patient was hospitalized.
Novorapid Side Effect Report#9867574
Alanine Aminotransferase Increased, Intentional Overdose
This report suggests a potential Novorapid Alanine Aminotransferase Increased side effect(s) that can have serious consequences. A 56-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: diabetes mellitus and used Novorapid (dosage: 500 U, Single) starting
Jan 12, 2014. After starting Novorapid the patient began experiencing various side effects, including: Alanine Aminotransferase Increased, Intentional OverdoseAdditional drugs used concurrently:
  • Lantus (30 U, Qd)
  • Lantus (140 U, Single)
The patient was hospitalized. Although Novorapid demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Alanine Aminotransferase Increased, may still occur.
Novorapid Side Effect Report#9846094
Hypersensitivity, Blood Glucose Increased
This Hypersensitivity problem was reported by a health professional from BG. A 40-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: type 1 diabetes mellitus. On 201312 this consumer started treatment with Novorapid Penfill (dosage: 18 U, Qd (3x6 Units)). The following drugs were being taken at the same time: NA. When using Novorapid Penfill, the patient experienced the following unwanted symptoms/side effects: Hypersensitivity, Blood Glucose IncreasedThe 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 Hypersensitivity, may become evident only after a product is in use by the general population.
Novorapid Side Effect Report#9832103
Viral Infection, Application Site Haematoma
This Viral Infection side effect was reported by a consumer or non-health professional from BR. A male patient (weight:NA) experienced the following symptoms/conditions: type 1 diabetes mellitus.The patient was prescribed Novorapid Flexpen (drug dosage: 14 To 15 Iu, 6 Times Daily), which was initiated on 201305. Concurrently used drugs: NA..After starting to take Novorapid Flexpen the consumer reported adverse symptoms, such as: Viral Infection, Application Site HaematomaThese side effects may potentially be related to Novorapid Flexpen. The patient was hospitalized.
Novorapid Side Effect Report#9825963
Suicide Attempt, Intentional Overdose, Hypoglycaemic Unconsciousness
This is a report of a 53-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: type 1 diabetes mellitus, who was treated with Novorapid Penfill (dosage: 6 U, Tid (approx 6 Units Per Meal=18 Units Total Daily), start time: NS), combined with:
  • Insulatard (Unk)
  • Fluoxetine (Unk)
  • Fluoxetine
and developed a serious reaction and side effect(s): Suicide Attempt, Intentional Overdose, Hypoglycaemic Unconsciousness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Novorapid Penfill treatment in female patients, resulting in Suicide Attempt side effect. The patient was hospitalized.
Novorapid Side Effect Report#9803421
Renal Failure Acute
This report suggests a potential Novorapid Renal Failure Acute side effect(s) that can have serious consequences. A 80-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: diabetes mellitus,endocarditis and used Novorapid (dosage: One Dose) starting
Aug 19, 2013. After starting Novorapid the patient began experiencing various side effects, including: Renal Failure AcuteAdditional drugs used concurrently:
  • Clamoxyl (amoxicillin) (3 G, Qid)
  • Clamoxyl (amoxicillin) (12 G, Qd)
The patient was hospitalized. Although Novorapid demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Failure Acute, may still occur.
Novorapid Side Effect Report#9801092
Abortion Spontaneous, Exposure During Pregnancy
This Abortion Spontaneous problem was reported by a consumer or non-health professional from TR. A 34-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On
Mar 28, 2013 this consumer started treatment with Novorapid Flexpen (dosage: 12 U, Qd). The following drugs were being taken at the same time:
  • Levemir Flexpen (8 U, Qd)
  • Alfamet (250 Mg, Tid)
When using Novorapid Flexpen, the patient experienced the following unwanted symptoms/side effects: Abortion Spontaneous, Exposure During PregnancyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abortion Spontaneous, may become evident only after a product is in use by the general population.
Novorapid Side Effect Report#9795907
Cardiac Failure, Diabetes Mellitus Inadequate Control, Hypoglycaemia
This Cardiac Failure side effect was reported by a physician from JP. A 65-year-old patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Novorapid Chu Flexpen (drug dosage: 160 Iu, Qd), which was initiated on NS. Concurrently used drugs: NA..After starting to take Novorapid Chu Flexpen the consumer reported adverse symptoms, such as: Cardiac Failure, Diabetes Mellitus Inadequate Control, HypoglycaemiaThese side effects may potentially be related to Novorapid Chu Flexpen. The patient was hospitalized.
Novorapid Side Effect Report#9788817
Suicide Attempt, Intentional Overdose, Hypoglycaemia
This is a report of a 86-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: suicide attempt, who was treated with Novorapid 30 Mix Chu Flexpen (dosage: Unk, start time: 2008), combined with: NA. and developed a serious reaction and side effect(s): Suicide Attempt, Intentional Overdose, Hypoglycaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Novorapid 30 Mix Chu Flexpen treatment in female patients, resulting in Suicide Attempt side effect. The patient was hospitalized.
Novorapid Side Effect Report#9788803
Infection, Blood Glucose Increased
This report suggests a potential Novorapid Infection side effect(s) that can have serious consequences. A 34-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: type 1 diabetes mellitus and used Novorapid (dosage: Carbohydrate Counting) starting NS. After starting Novorapid the patient began experiencing various side effects, including: Infection, Blood Glucose IncreasedAdditional drugs used concurrently:
  • Lantus (22 U At Morning)
The patient was hospitalized. Although Novorapid demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Infection, may still occur.
Novorapid Side Effect Report#9778619
Incorrect Dose Administered
This Incorrect Dose Administered problem was reported by a health professional from BR. A 19-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 2010 this consumer started treatment with Novorapid Penfill (dosage: Unk). The following drugs were being taken at the same time:
  • Lantus
When using Novorapid Penfill, the patient experienced the following unwanted symptoms/side effects: Incorrect Dose AdministeredAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Incorrect Dose Administered, may become evident only after a product is in use by the general population.
Novorapid Side Effect Report#9774412
Suicide Attempt, Intentional Overdose
This Suicide Attempt side effect was reported by a physician from AU. A 23-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Novorapid Flexpen (drug dosage: 6 U, Tid (usually On 6 Units)), which was initiated on NS. Concurrently used drugs:
  • Insulin Glargine
.After starting to take Novorapid Flexpen the consumer reported adverse symptoms, such as: Suicide Attempt, Intentional OverdoseThese side effects may potentially be related to Novorapid Flexpen. The patient was hospitalized.
Novorapid Side Effect Report#9752644
Respiratory Arrest, Overdose, Hypoglycaemia, Convulsion, Hyperglycaemia
This is a report of a 69-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: diabetes mellitus, who was treated with Novorapid Flexpen (dosage: 20 U, Tid (60 U Qd), start time:
Nov 04, 2013), combined with: NA. and developed a serious reaction and side effect(s): Respiratory Arrest, Overdose, Hypoglycaemia, Convulsion, Hyperglycaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Novorapid Flexpen treatment in female patients, resulting in Respiratory Arrest side effect. The patient was hospitalized.
Novorapid Side Effect Report#9748455
Hypoglycaemia
This report suggests a potential Novorapid Hypoglycaemia side effect(s) that can have serious consequences. A 19-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: type 1 diabetes mellitus and used Novorapid (dosage: 32 Iu, Qd) starting NS. After starting Novorapid the patient began experiencing various side effects, including: HypoglycaemiaAdditional drugs used concurrently:
  • Insulatard (8 Iu, Qid (8 Iu Four Times Daily))
  • Levocarnil (6 Df, Qd (6 Pharmaceutical Doses Daily))
  • Zelitrex (500 Mg)
  • Beflavine (10 Mg)
  • Levothyrox (75 ?g, Qd)
The patient was hospitalized. Although Novorapid demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypoglycaemia, may still occur.
Novorapid Side Effect Report#9739246
Premature Baby, Poor Sucking Reflex, Vomiting Neonatal
This Premature Baby problem was reported by a consumer or non-health professional from TR. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: gestational diabetes. On 201304 this consumer started treatment with Novorapid Flexpen (dosage: 9 U, Qd). The following drugs were being taken at the same time: NA. When using Novorapid Flexpen, the patient experienced the following unwanted symptoms/side effects: Premature Baby, Poor Sucking Reflex, Vomiting NeonatalThe 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 Premature Baby, may become evident only after a product is in use by the general population.
Novorapid Side Effect Report#9739241
Suicide Attempt, Intentional Overdose, Hypoglycaemia
This Suicide Attempt side effect was reported by a physician from JP. A 47-year-old female patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Novorapid Chu (drug dosage: 600 Iu, Qd), which was initiated on NS. Concurrently used drugs:
  • Lendormin (15 Mg, Single (60 Tablets Of 0.25mg Orally))
.After starting to take Novorapid Chu the consumer reported adverse symptoms, such as: Suicide Attempt, Intentional Overdose, HypoglycaemiaThese side effects may potentially be related to Novorapid Chu. The patient was hospitalized.
Novorapid Side Effect Report#9735361
Vaginal Haemorrhage, Pregnancy
This is a report of a female patient (weight: NA) from TR, suffering from the following health symptoms/conditions: gestational diabetes,vitamin supplementation,mineral supplementation, who was treated with Novorapid Flexpen (dosage: 24 U, Qd, start time: 201303), combined with:
  • Elevit /01730301/ (1 Per Day)
  • Ferrosanol (1 Caps, Qd)
and developed a serious reaction and side effect(s): Vaginal Haemorrhage, Pregnancy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Novorapid Flexpen treatment in female patients, resulting in Vaginal Haemorrhage side effect.


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The appearance of Novorapid 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.

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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.

    Novorapid 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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    More About Novorapid

    Side Effects reported to FDA: 1139

    Novorapid safety alerts: No

    Reported deaths: 21

    Reported hospitalizations: 244

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