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Novomix Side Effects

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Common Novomix Side Effects


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

Hypoglycaemia (63)
Blood Glucose Increased (37)
Death (21)
Vomiting (18)
Dizziness (18)
Dyspnoea (16)
Fall (15)
Nausea (15)
Hyperglycaemia (15)
Malaise (14)
Hypoglycaemic Coma (14)
Loss Of Consciousness (13)
Product Quality Issue (13)
Oedema Peripheral (12)
Diabetes Mellitus Inadequate Control (11)
Hyperhidrosis (11)
Cerebrovascular Accident (11)
Suicide Attempt (11)
Syncope (11)
Intentional Overdose (11)

➢ 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.

Novomix Side Effects Reported to FDA



Novomix Side Effect Report#9919366
Hypertension, Blood Glucose Increased
This is a report of a male patient (weight: NA) from TR, suffering from the following health symptoms/conditions: diabetes mellitus, who was treated with Novomix 30 Flexpen (dosage: Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Hypertension, Blood Glucose Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Novomix 30 Flexpen treatment in male patients, resulting in Hypertension side effect. The patient was hospitalized.
Novomix Side Effect Report#9897782
Retinopathy
This report suggests a potential Novomix 30 Penfill Retinopathy side effect(s) that can have serious consequences. A 35-year-old male patient (weight: NA) from CN was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Novomix 30 Penfill (dosage: 26 U, Qd (14 U/morning + 12 U/evening)) starting 201204. After starting Novomix 30 Penfill the patient began experiencing various side effects, including: RetinopathyAdditional drugs used concurrently: NA. Although Novomix 30 Penfill demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Retinopathy, may still occur.
Novomix Side Effect Report#9897777
Cough, Rash
This Cough problem was reported by a health professional from GB. A 47-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On
Dec 31, 2013 this consumer started treatment with Novomix 30 Flexpen (dosage: Unk). The following drugs were being taken at the same time: NA. When using Novomix 30 Flexpen, the patient experienced the following unwanted symptoms/side effects: Cough, RashAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cough, may become evident only after a product is in use by the general population.
Novomix Side Effect Report#9862351
Loss Of Consciousness, Dysarthria, Feeling Abnormal, Lethargy, Memory Impairment, Blood Glucose Fluctuation
This Loss Of Consciousness side effect was reported by a consumer or non-health professional from GB. A 42-year-old female patient (weight:NA) experienced the following symptoms/conditions: type 1 diabetes mellitus.The patient was prescribed Novomix 30 (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Novomix 30 the consumer reported adverse symptoms, such as: Loss Of Consciousness, Dysarthria, Feeling Abnormal, Lethargy, Memory Impairment, Blood Glucose FluctuationThese side effects may potentially be related to Novomix 30.
Novomix Side Effect Report#9846108
Premature Baby, Dyspnoea, Foetal Exposure During Pregnancy
This is a report of a male patient (weight: NA) from ZA, suffering from the following health symptoms/conditions: gestational diabetes, who was treated with Novomix 30 Flexpen (dosage: 44 Iu, Qd, start time:
Jun 09, 2013), combined with:
  • Folic Acid
  • Multivitamin /00097801/
and developed a serious reaction and side effect(s): Premature Baby, Dyspnoea, Foetal Exposure During Pregnancy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Novomix 30 Flexpen treatment in male patients, resulting in Premature Baby side effect. The patient was hospitalized.
Novomix Side Effect Report#9830537
Cerebrovascular Accident, Epilepsy, Renal Impairment, Delirium, Pyrexia, Blood Glucose Fluctuation
This report suggests a potential Novomix 30 Flexpen Cerebrovascular Accident side effect(s) that can have serious consequences. A 85-year-old male patient (weight: NA) from NL was diagnosed with the following symptoms/conditions: NA and used Novomix 30 Flexpen (dosage: Unk) starting NS. After starting Novomix 30 Flexpen the patient began experiencing various side effects, including: Cerebrovascular Accident, Epilepsy, Renal Impairment, Delirium, Pyrexia, Blood Glucose FluctuationAdditional drugs used concurrently: NA.The patient was hospitalized. Although Novomix 30 Flexpen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cerebrovascular Accident, may still occur.
Novomix Side Effect Report#9808098
Serratia Infection, Blood Glucose Increased, Wound Secretion
This Serratia Infection problem was reported by a consumer or non-health professional from NL. A 62-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Oct 15, 2013 this consumer started treatment with Novomix 30 Flexpen (dosage: 100 Ml). The following drugs were being taken at the same time: NA. When using Novomix 30 Flexpen, the patient experienced the following unwanted symptoms/side effects: Serratia Infection, Blood Glucose Increased, Wound SecretionThe 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 Serratia Infection, may become evident only after a product is in use by the general population.
Novomix Side Effect Report#9789035
Sepsis, Urinary Tract Infection Bacterial, Cerebrovascular Accident, Hypoglycaemic Unconsciousness, Hypoglycaemia, Blood Glucose Fluctuation, Blood Glucose Increased
This Sepsis side effect was reported by a consumer or non-health professional from GB. A 88-year-old female patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Novomix 30 Flexpen (drug dosage: 24/18 Iu), which was initiated on 2003. Concurrently used drugs:
  • Novorapid Flexpen (3u If Bg Above 15)
.After starting to take Novomix 30 Flexpen the consumer reported adverse symptoms, such as: Sepsis, Urinary Tract Infection Bacterial, Cerebrovascular Accident, Hypoglycaemic Unconsciousness, Hypoglycaemia, Blood Glucose Fluctuation, Blood Glucose IncreasedThese side effects may potentially be related to Novomix 30 Flexpen.
Novomix Side Effect Report#9786544
Biliary Colic, Blood Glucose Increased
This is a report of a 66-year-old male patient (weight: NA) from DE, suffering from the following health symptoms/conditions: type 2 diabetes mellitus,coronary artery disease,hypertension,hypercholesterolaemia, who was treated with Novomix 30 Flexpen (dosage: NA, start time: 2003), combined with:
  • Delix /00885601/ (5 Mg, Bid)
  • Bisoprolol (5 Mg, Qd)
  • Simvastatin (40 Mg, Qd)
  • Metformin
  • Ass
and developed a serious reaction and side effect(s): Biliary Colic, Blood Glucose Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Novomix 30 Flexpen treatment in male patients, resulting in Biliary Colic side effect. The patient was hospitalized.
Novomix Side Effect Report#9759511
Soft Tissue Injury, Hypoglycaemia
This report suggests a potential Novomix 30 Soft Tissue Injury side effect(s) that can have serious consequences. A 26-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Novomix 30 (dosage: Unk) starting
Sep 02, 2013. After starting Novomix 30 the patient began experiencing various side effects, including: Soft Tissue Injury, HypoglycaemiaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Novomix 30 demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Soft Tissue Injury, may still occur.
Novomix Side Effect Report#9752526
Vomiting, Hiccups, Blood Glucose Increased
This Vomiting problem was reported by a consumer or non-health professional from ZA. A 42-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On NS this consumer started treatment with Novomix 30 Flexpen (dosage: 65 Iu, Qd 930iu Breakfast, 35iu Night)). The following drugs were being taken at the same time: NA. When using Novomix 30 Flexpen, the patient experienced the following unwanted symptoms/side effects: Vomiting, Hiccups, 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 Vomiting, may become evident only after a product is in use by the general population.
Novomix Side Effect Report#9745617
Lung Infection
This Lung Infection side effect was reported by a consumer or non-health professional from GB. A 72-year-old male patient (weight:NA) experienced the following symptoms/conditions: diabetes mellitus.The patient was prescribed Novomix 30 Flexpen (drug dosage: Bid), which was initiated on 201301. Concurrently used drugs: NA..After starting to take Novomix 30 Flexpen the consumer reported adverse symptoms, such as: Lung InfectionThese side effects may potentially be related to Novomix 30 Flexpen. The patient was hospitalized.
Novomix Side Effect Report#9728439
Gastritis, Blood Glucose Increased
This is a report of a 52-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Novomix 30 Flexpen (dosage: Between 8 - 12 Units, Twice A Day, Depending On Glucose Levels, start time: 201201), combined with:
  • Metformin (Unk)
and developed a serious reaction and side effect(s): Gastritis, Blood Glucose Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Novomix 30 Flexpen treatment in male patients, resulting in Gastritis side effect. The patient was hospitalized.
Novomix Side Effect Report#9723211
Dizziness, Hyperhidrosis, Syncope, Speech Disorder, Balance Disorder, Pallor, Pain, Disorientation
This report suggests a potential Novomix 30 Flexpen Dizziness side effect(s) that can have serious consequences. A female patient (weight: NA) from HR was diagnosed with the following symptoms/conditions: diabetes mellitus and used Novomix 30 Flexpen (dosage: 50 U, Qd, 36 U Morning And 14 U Evening) starting
Dec 29, 2012. After starting Novomix 30 Flexpen the patient began experiencing various side effects, including: Dizziness, Hyperhidrosis, Syncope, Speech Disorder, Balance Disorder, Pallor, Pain, DisorientationAdditional drugs used concurrently:
  • Siofor (1 Tab, Bid, 1 Tab Morning , 1 Tab Evening)
  • Prexanil A (10 Mg, Qd, 5 Mg Morning, 5 Mg Evening)
  • Lescol (80 Mg, Qd)
  • Martefarin (3 Mg, Qd)
  • Cefixime (29122012 Unk, Unk)
Although Novomix 30 Flexpen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dizziness, may still occur.
Novomix Side Effect Report#9722893
Dyspnoea, Hypoglycaemia, Hypoglycaemia
This Dyspnoea problem was reported by a physician from NL. A 78-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On NS this consumer started treatment with Novomix 30 Flexpen (dosage: NA). The following drugs were being taken at the same time: NA. When using Novomix 30 Flexpen, the patient experienced the following unwanted symptoms/side effects: Dyspnoea, Hypoglycaemia, HypoglycaemiaThe 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 Dyspnoea, may become evident only after a product is in use by the general population.
Novomix Side Effect Report#9711361
Product Quality Issue
This Product Quality Issue side effect was reported by a consumer or non-health professional from GB. A 81-year-old female patient (weight:NA) experienced the following symptoms/conditions: diabetes mellitus.The patient was prescribed Novomix 30 Penfill (drug dosage: Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Novomix 30 Penfill the consumer reported adverse symptoms, such as: Product Quality IssueThese side effects may potentially be related to Novomix 30 Penfill. The patient was hospitalized.
Novomix Side Effect Report#9711350
Tachycardia, Diabetic Ketoacidosis
This is a report of a 15-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: type 1 diabetes mellitus, who was treated with Novomix 30 Flexpen (dosage: 30 Iu, Qd, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Tachycardia, Diabetic Ketoacidosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Novomix 30 Flexpen treatment in male patients, resulting in Tachycardia side effect. The patient was hospitalized.
Novomix Side Effect Report#9697890
Paraesthesia, Skin Exfoliation, Insomnia, Irritability, Pain, Fatigue, Rash, Pruritus
This report suggests a potential Novomix 30 Penfill Paraesthesia side effect(s) that can have serious consequences. A 53-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: diabetes mellitus and used Novomix 30 Penfill (dosage: 50 Iu, Bid) starting NS. After starting Novomix 30 Penfill the patient began experiencing various side effects, including: Paraesthesia, Skin Exfoliation, Insomnia, Irritability, Pain, Fatigue, Rash, PruritusAdditional drugs used concurrently: NA. Although Novomix 30 Penfill demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Paraesthesia, may still occur.
Novomix Side Effect Report#9695196
Cognitive Disorder, Activities Of Daily Living Impaired, Hypoglycaemia, Hyperglycaemia, Aggression, Malaise, Hyperinsulinaemia, Product Quality Issue
This Cognitive Disorder problem was reported by a health professional from GB. A 60-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: type 1 diabetes mellitus. On 201305 this consumer started treatment with Novomix 30 Penfill (dosage: 32 U, Qd). The following drugs were being taken at the same time: NA. When using Novomix 30 Penfill, the patient experienced the following unwanted symptoms/side effects: Cognitive Disorder, Activities Of Daily Living Impaired, Hypoglycaemia, Hyperglycaemia, Aggression, Malaise, Hyperinsulinaemia, Product Quality IssueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cognitive Disorder, may become evident only after a product is in use by the general population.
Novomix Side Effect Report#9695193
Loss Of Consciousness, Chest Pain, Vomiting, Blood Glucose Decreased, Blood Glucose Increased
This Loss Of Consciousness side effect was reported by a consumer or non-health professional from GB. A 51-year-old male patient (weight:NA) experienced the following symptoms/conditions: diabetes mellitus.The patient was prescribed Novomix 30 Penfill (drug dosage: NA), which was initiated on 2004. Concurrently used drugs: NA..After starting to take Novomix 30 Penfill the consumer reported adverse symptoms, such as: Loss Of Consciousness, Chest Pain, Vomiting, Blood Glucose Decreased, Blood Glucose IncreasedThese side effects may potentially be related to Novomix 30 Penfill.
Novomix Side Effect Report#9693164
Chest Pain, Head Injury, Hypoglycaemic Unconsciousness, Hypoglycaemic Unconsciousness
This is a report of a 47-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: type 1 diabetes mellitus, who was treated with Novomix 30 Flexpen (dosage: 84 U, Qd (48 U Am, 36u Pm), start time:
Aug 16, 2010), combined with: NA. and developed a serious reaction and side effect(s): Chest Pain, Head Injury, Hypoglycaemic Unconsciousness, Hypoglycaemic Unconsciousness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Novomix 30 Flexpen treatment in male patients, resulting in Chest Pain side effect. The patient was hospitalized.
Novomix Side Effect Report#9690516
Epilepsy, Hypoglycaemia
This report suggests a potential Novomix 30 Flexpen Epilepsy side effect(s) that can have serious consequences. A 75-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: type 1 diabetes mellitus and used Novomix 30 Flexpen (dosage: 118 Iu, Qd) starting NS. After starting Novomix 30 Flexpen the patient began experiencing various side effects, including: Epilepsy, HypoglycaemiaAdditional drugs used concurrently:
  • Avlocardyl /00030001/
  • Previscan /00261401/
  • Allopurinol
  • Diffu-k
  • Furosemide
  • Irbesartan
  • Metformine
  • Fluvastatine
The patient was hospitalized. Although Novomix 30 Flexpen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Epilepsy, may still occur.
Novomix Side Effect Report#9690513
Premature Baby, Foetal Exposure During Pregnancy
This Premature Baby problem was reported by a health professional from GR. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: gestational diabetes. On NS this consumer started treatment with Novomix 30 Flexpen (dosage: NA). The following drugs were being taken at the same time: NA. When using Novomix 30 Flexpen, the patient experienced the following unwanted symptoms/side effects: Premature Baby, Foetal Exposure During PregnancyThe 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.
Novomix Side Effect Report#9690512
Pneumothorax, Hypoglycaemia, Hypoglycaemic Coma, Anxiety, Urine Output Increased, Pollakiuria, Thirst, Hypoglycaemia, Incorrect Dose Administered By Device
This Pneumothorax side effect was reported by a consumer or non-health professional from GB. A 84-year-old female patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Novomix 30 Penfill (drug dosage: 60 U, Qd (25 Am + 35 Pm)), which was initiated on
Nov 28, 2013. Concurrently used drugs: NA..After starting to take Novomix 30 Penfill the consumer reported adverse symptoms, such as: Pneumothorax, Hypoglycaemia, Hypoglycaemic Coma, Anxiety, Urine Output Increased, Pollakiuria, Thirst, Hypoglycaemia, Incorrect Dose Administered By DeviceThese side effects may potentially be related to Novomix 30 Penfill. The patient was hospitalized.
Novomix Side Effect Report#9690511
Premature Baby, Foetal Exposure During Pregnancy
This is a report of a male patient (weight: NA) from GR, suffering from the following health symptoms/conditions: gestational diabetes, who was treated with Novomix 30 Flexpen (dosage: 4 Iu, Qd, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Premature Baby, Foetal Exposure During Pregnancy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Novomix 30 Flexpen treatment in male patients, resulting in Premature Baby side effect. The patient was hospitalized.


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The appearance of Novomix 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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What are common Novomix Side Effects for Women?

Women Side EffectsReports
Hypoglycaemia 33
Blood Glucose Increased 19
Nausea 14
Vomiting 12
Malaise 11
Oedema Peripheral 11
Abdominal Pain 10
Dizziness 10
Hypoglycaemic Coma 10
Pain 10

What are common Novomix Side Effects for Men?

Men Side EffectsReports
Hypoglycaemia 30
Blood Glucose Increased 17
Death 12
Dyspnoea 10
Hyperglycaemia 10
Dizziness 8
Renal Failure 8
Syncope 8
Loss Of Consciousness 7
Myocardial Infarction 7

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.

    Novomix 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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