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Actraphane Side Effects

Common Actraphane Side Effects


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

Diarrhoea (5)
Mental Disorder (4)
Renal Failure (4)
Hypoglycaemia (4)
Cardiac Arrest (4)
Fall (4)
Blood Glucose Decreased (4)
Anaemia Haemolytic Autoimmune (4)
Rhabdomyolysis (4)
Blood Glucose Increased (4)
Hypertension (3)
Haemolytic Anaemia (3)
Hyperglycaemia (3)
Syncope (3)
Loss Of Consciousness (3)
Delirium Tremens (3)
Shock Hypoglycaemic (3)
Arrhythmia (2)
Vomiting (2)
Pneumocystis Jiroveci Pneumonia (2)

➢ 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.

Actraphane Side Effects Reported to FDA

The following Actraphane 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 Actraphane 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.
Accidental Overdose, Altered State Of Consciousness, Diarrhoea, Chest Pain, Tremor, Hyperhidrosis
This is a report of a 65-year-old female patient (weight: NA) from ZA, suffering from the following symptoms/conditions: type 2 diabetes mellitus, who was treated with Actraphane 30 Flexpen (dosage: 66 Iu, Qd, start time: 200701), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Accidental Overdose
  • Altered State Of Consciousness
  • Diarrhoea
  • Chest Pain
  • Tremor
  • Hyperhidrosis
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actraphane 30 Flexpen treatment in female patients, resulting in accidental overdose side effect.

B-cell Lymphoma, Bone Sarcoma
This report suggests a potential Actraphane 30 Penfill B-cell Lymphoma, Bone Sarcoma side effect(s) that can have serious consequences. A 90-year-old female patient (weight: NA) from GERMANY was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Actraphane 30 Penfill (dosage: NA) starting Jan 01, 1999. Soon after starting Actraphane 30 Penfill the patient began experiencing various side effects, including:
  • B-cell Lymphoma
  • Bone Sarcoma
Drugs used concurrently:
  • Novodigal Mite (Unk, Qd)
  • Pentaerythritol Tetranitrate (Unk, Bid)
  • Herz Ass 100 (Unk, Qd)
  • Losartan Comp. 100/25 (Unk)
The patient was hospitalized. Although Actraphane 30 Penfill demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as b-cell lymphoma, may still occur.

Gastrointestinal Carcinoma, Diabetic Foot
This Gastrointestinal Carcinoma, Diabetic Foot problem was reported by a consumer or non-health professional from GERMANY. A 67-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Apr 01, 2009 this consumer started treatment with Actraphane Mc (dosage: NA). The following drugs were being taken at the same time:
  • Metformin Hydrochloride
When commencing Actraphane Mc, the patient experienced the following unwanted symptoms/side effects:
  • Gastrointestinal Carcinoma
  • Diabetic Foot
The 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 gastrointestinal carcinoma, may become evident only after a product is in use by the general population.

Pneumocystis Jiroveci Pneumonia, Hiv Infection
This is a report of a 62-year-old male patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: type 2 diabetes mellitus and was treated with Actraphane (dosage: Unk-07dec10,92iu 08dec10-14jun11,82iu 15jun-17dec11,92iu/u 18-25dec11,80iu/u 28dec11-07jan12) starting Dec 18, 2011. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Pneumocystis Jiroveci Pneumonia
  • Hiv Infection
The patient was hospitalized. This opens a possibility that Actraphane treatment could cause the above reactions, including pneumocystis jiroveci pneumonia, and some male subjects may be more susceptible.


Gastric Ulcer, Gastric Haemorrhage, Vomiting, Hypoacusis, Haemoglobin, Haematemesis, Helicobacter Test Positive, Urinary Tract Infection, Wound
A female patient (weight: NA) from GERMANY with the following symptoms/conditions: NA started Actraphane treatment (dosage: 30 Anz) on Sep 16, 2011. Soon after starting Actraphane treatment, the subject experienced various side effects, including:
  • Gastric Ulcer
  • Gastric Haemorrhage
  • Vomiting
  • Hypoacusis
  • Haemoglobin
  • Haematemesis
  • Helicobacter Test Positive
  • Urinary Tract Infection
  • Wound
Concurrently used drugs:
  • Calcium D3 (2 Anz)
  • Hydrochlorothiazide (12.5 Nr)
  • Novalgin (4 Anz)
  • Pradaxa
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Actraphane.

Pneumocystis Jiroveci Pneumonia, Hiv Infection
A 62-year-old male patient from UNITED STATES (weight: NA) experienced symptoms, such as: type 2 diabetes mellitus and was treated with Actraphane(dosage: Unk-07dec10,92iu 08dec10-14jun11,82iu 15jun11-unk,92iu/u). The treatment was initiated on Dec 07, 2010. After that a consumer reported the following side effect(s):
  • Pneumocystis Jiroveci Pneumonia
  • Hiv Infection
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Actraphane efficacy: NA.The patient was hospitalized.

Pericardial Haemorrhage
In this report, Actraphane Hm 30/70 was administered for the following condition: NA.A 76-year-old female consumer from GERMANY (weight: NA) started Actraphane Hm 30/70 treatment (dosage: NA) on Dec 22, 2011.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Pericardial Haemorrhage
A possible interaction with other drugs could have contributed to this reaction:
  • Vemurafenib (Last Dose Prior To Sae:30 Nov 2011)
  • Perindopril Erbumine
  • Aspirin
  • Xipamid
  • Falithrom
  • Concor 5
  • Pentaerythritol Tetranitrate
  • Torsemide
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 Actraphane Hm 30/70 treatment could be related to the listed above side effect(s).

Dialysis
This is a report of the following Actraphane (insulin Human, Insulin Human Injection, Isophane) side effect(s):
  • Dialysis
A 33-year-old male patient from SOUTH AFRICA (weight: NA) presented with the following condition: NA and received a treatment with Actraphane (insulin Human, Insulin Human Injection, Isophane) (dosage: NA) starting: NS.The following concurrently used drugs could have generated interactions:
  • Actos
This report suggests that a Actraphane (insulin Human, Insulin Human Injection, Isophane) treatment could be associated with the listed above side effect(s).

Hyperglycaemia, Haemolytic Anaemia, Anaemia Haemolytic Autoimmune
This Actraphane 30 Penfill report was submitted by a 77-year-old male consumer from GERMANY (weight: NA). The patient was diagnosed with: NA and Actraphane 30 Penfill was administered (dosage: Unk) starting: Jul 01, 2007. The consumer developed a set of symptoms:
  • Hyperglycaemia
  • Haemolytic Anaemia
  • Anaemia Haemolytic Autoimmune
Other drugs used simultaneously: NA.The patient was hospitalized.Those unexpected symptoms could be linked to a Actraphane 30 Penfill treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Anaemia Haemolytic Autoimmune, Haemolytic Anaemia, Hyperglycaemia
This is a report of a possible correlation between Actraphane 30 Penfill use and the following symptoms/side effect(s):
  • Anaemia Haemolytic Autoimmune
  • Haemolytic Anaemia
  • Hyperglycaemia
which could contribute to an assessment of Actraphane 30 Penfill risk profile.A 77-year-old male consumer from GERMANY (weight: NA) was suffering from type 2 diabetes mellitus and was treated with Actraphane 30 Penfill (dosage: Unk) starting Jul 25, 2007.Other concurrent medications: NA.The patient was hospitalized.

Hypertension, Shock Hypoglycaemic
A 82-year-old male patient from GERMANY (weight: NA) presented with the following symptoms: type 2 diabetes mellitus and after a treatment with Actraphane 30 Penfill (dosage: 56 Iu, Qd) experienced the following side effect(s):
  • Hypertension
  • Shock Hypoglycaemic
The treatment was started on Apr 29, 2008. Actraphane 30 Penfill was used in combination with the following drugs:
  • Actrapid Novolet (16 Iu, Qd)
  • Atacand (32 Mg, Qd)
  • Carmen (20 Mg, Qd)
  • Doxazosin Mesylate (2 Mg, Qd)
  • Hydrochlorothiazide (25 Mg, Qd)
  • Moxonidine (.6 Mg, Qd)
  • Simvastatin (10 Mg, Qd)
  • Metoprolol Succinate (95 Mg, Bid)
The patient was hospitalized.This report could alert potential Actraphane 30 Penfill consumers.

Blood Glucose Decreased, Blood Glucose Increased, Cardiac Arrest, Delirium Tremens, Diarrhoea, Fall, Hypoglycaemia, Renal Failure, Rhabdomyolysis
In this report, a 74-year-old male patient from GERMANY (weight: NA) was affected by a possible Actraphane 30 Penfill side effect.The patient was diagnosed with type 2 diabetes mellitus. After a treatment with Actraphane 30 Penfill (dosage: 45 Iu, Bid, start date: Jan 01, 2008), the patient experienced the following side effect(s):
  • Blood Glucose Decreased
  • Blood Glucose Increased
  • Cardiac Arrest
  • Delirium Tremens
  • Diarrhoea
  • Fall
  • Hypoglycaemia
  • Renal Failure
  • Rhabdomyolysis
The following simultaneously used drugs could have led to this reaction: NA.The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Actraphane 30 Penfill treatment.

Arrhythmia
This is a report of a 54-year-old female patient from GERMANY (weight: NA), who used Actraphane 30 Innolet (dosage: Unk) for a treatment of diabetes mellitus. After starting a treatment on Feb 20, 2010, the patient experienced the following side effect(s):
  • Arrhythmia
The following drugs could possibly have interacted with the Actraphane 30 Innolet treatment
  • Simvastatin
  • Metoprolol Succinate
  • Amlodipin /00972401/
The patient was hospitalized.Taken together, these observations suggest that a Actraphane 30 Innolet treatment could be related to side effect(s), such as Arrhythmia.

Arrhythmia
This arrhythmia side effect was reported by a pharmacist from GERMANY. A 54-year-old female patient (weight:NA) experienced the following symptoms/conditions: diabetes mellitus. The patient was prescribed Actraphane 30 Innolet (dosage: Unk), which was started on Feb 20, 2010. Concurrently used drugs:
  • Simvastatin
  • Metoprolol Succinate
  • Amlodipin /00972401/
When starting to take Actraphane 30 Innolet the consumer reported the following symptoms:
  • Arrhythmia
The patient was hospitalized. These side effects may potentially be related to Actraphane 30 Innolet.

Anaemia Haemolytic Autoimmune, Haemolytic Anaemia, Hyperglycaemia
This is a Actraphane 30 Penfill side effect report of a 77-year-old male patient (weight:NA) from GERMANY, suffering from the following symptoms/conditions: type 2 diabetes mellitus, who was treated with Actraphane 30 Penfill (dosage:Unk, start time: Jul 25, 2007), combined with: NA., and developed a serious reaction and a anaemia haemolytic autoimmune side effect. The patient presented with:
  • Anaemia Haemolytic Autoimmune
  • Haemolytic Anaemia
  • Hyperglycaemia
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Actraphane 30 Penfill treatment in male patients suffering from type 2 diabetes mellitus, resulting in anaemia haemolytic autoimmune.

Anaemia Haemolytic Autoimmune
This report suggests a potential Actraphane 30 Penfill anaemia haemolytic autoimmune side effect(s) that can have serious consequences. A 77-year-old male patient from GERMANY (weight:NA) was diagnosed with the following health condition(s): NA and used Actraphane 30 Penfill (dosage: Unk) starting Mar 05, 2009. Soon after starting Actraphane 30 Penfill the patient began experiencing various side effects, including:
  • Anaemia Haemolytic Autoimmune
Drugs used concurrently:NA. The patient was hospitalized. Although Actraphane 30 Penfill demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as anaemia haemolytic autoimmune, may still occur.

Blood Glucose Decreased, Blood Glucose Increased, Cardiac Arrest, Delirium Tremens, Diarrhoea, Fall, Hypoglycaemia, Renal Failure, Rhabdomyolysis
This blood glucose decreased problem was reported by a physician from GERMANY. A 74-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): type 2 diabetes mellitus.On Jan 01, 2008 a consumer started treatment with Actraphane 30 Penfill (dosage: 45 Iu, Bid). The following drugs/medications were being taken at the same time: NA. When commencing Actraphane 30 Penfill, the patient experienced the following unwanted symptoms /side effects:
  • Blood Glucose Decreased
  • Blood Glucose Increased
  • Cardiac Arrest
  • Delirium Tremens
  • Diarrhoea
  • Fall
  • Hypoglycaemia
  • Renal Failure
  • Rhabdomyolysis
The patient was hospitalized. 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 Increased, Cardiac Arrest, Delirium Tremens, Diarrhoea, Fall, Hypoglycaemia, Renal Failure, Rhabdomyolysis
This is a Actraphane 30 Penfill side effect report of a 74-year-old male patient (weight: NA) from GERMANY. The patient developed the following symptoms/conditions: type 2 diabetes mellitus and was treated with Actraphane 30 Penfill (dosage: 45 Iu, Bid) starting Jan 01, 2008. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Blood Glucose Decreased
  • Blood Glucose Increased
  • Cardiac Arrest
  • Delirium Tremens
  • Diarrhoea
  • Fall
  • Hypoglycaemia
  • Renal Failure
  • Rhabdomyolysis
The patient was hospitalized. This opens a possibility that Actraphane 30 Penfill could cause blood glucose decreased and that some male patients may be more susceptible.

Hypertension, Shock Hypoglycaemic
A 82-year-old male patient (weight: NA) from GERMANY with the following symptoms: type 2 diabetes mellitus started Actraphane 30 Penfill treatment (dosage: 56 Iu, Qd) on Apr 29, 2008. Soon after starting Actraphane 30 Penfill treatment, the consumer experienced several side effects, including:
  • Hypertension
  • Shock Hypoglycaemic
. Concurrently used drugs:
  • Actrapid Novolet (16 Iu, Qd)
  • Atacand (32 Mg, Qd)
  • Carmen (20 Mg, Qd)
  • Doxazosin Mesylate (2 Mg, Qd)
  • Hydrochlorothiazide (25 Mg, Qd)
  • Moxonidine (.6 Mg, Qd)
  • Simvastatin (10 Mg, Qd)
  • Metoprolol Succinate (95 Mg, Bid)
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Actraphane 30 Penfill side effects, such as hypertension.

Alcohol Withdrawal Syndrome, Blood Glucose Decreased, Blood Glucose Increased, Cardiac Arrest, Diarrhoea, Fall, Hypoglycaemia, Renal Failure, Rhabdomyolysis
This alcohol withdrawal syndrome side effect was reported by a physician from GERMANY. A 74-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Actraphane 30 Penfill (dosage: 45 Iu, Bid), which was started on Jan 01, 2008. Concurrently used drugs: NA..When starting to take Actraphane 30 Penfill the consumer reported symptoms, such as:
  • Alcohol Withdrawal Syndrome
  • Blood Glucose Decreased
  • Blood Glucose Increased
  • Cardiac Arrest
  • Diarrhoea
  • Fall
  • Hypoglycaemia
  • Renal Failure
  • Rhabdomyolysis
These side effects may potentially be related to Actraphane 30 Penfill. The patient was hospitalized.

Hypertension, Shock Hypoglycaemic
This is a report of a 82-year-old male patient (weight: NA) from GERMANY, suffering from the following symptoms/conditions: type 2 diabetes mellitus, who was treated with Actraphane 30 Penfill (dosage: 56 Iu, Qd, start time: Apr 29, 2008), combined with:
  • Actrapid Novolet (16 Iu, Qd)
  • Atacand (32 Mg, Qd)
  • Carmen (20 Mg, Qd)
  • Doxazosin Mesylate (2 Mg, Qd)
  • Hydrochlorothiazide (25 Mg, Qd)
  • Moxonidine (.6 Mg, Qd)
  • Simvastatin (10 Mg, Qd)
  • Metoprolol Succinate (95 Mg, Bid)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Hypertension
  • Shock Hypoglycaemic
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Actraphane 30 Penfill treatment in male patients, resulting in hypertension side effect. The patient was hospitalized.

Mental Disorder, Nausea, Syncope, Vertigo, Vomiting
This report suggests a potential Actraphane 30 Novolet Mental Disorder, Nausea, Syncope, Vertigo, Vomiting side effect(s) that can have serious consequences. A 75-year-old male patient (weight: NA) from GERMANY was diagnosed with the following symptoms/conditions: diabetes mellitus and used Actraphane 30 Novolet (dosage: 32 Ie, Qd) starting NS. Soon after starting Actraphane 30 Novolet the patient began experiencing various side effects, including:
  • Mental Disorder
  • Nausea
  • Syncope
  • Vertigo
  • Vomiting
Drugs used concurrently:
  • Lyrica (2 Df, Qd)
  • Simvastatin (20 Mg, Qd)
  • Ass ^ct-arzneimittel^ (1 Df, Qd)
The patient was hospitalized. Although Actraphane 30 Novolet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as mental disorder, may still occur.

Glycosylated Haemoglobin Increased, Loss Of Consciousness, Mental Disorder, Syncope
This Glycosylated Haemoglobin Increased, Loss Of Consciousness, Mental Disorder, Syncope problem was reported by a pharmacist from GERMANY. A 75-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: diabetes mellitus. On NS this consumer started treatment with Actraphane 30 Novolet (dosage: 32 Ie, Qd). The following drugs were being taken at the same time:
  • Lyrica (2 Df, Qd)
  • Simvastatin (20 Mg, Qd)
  • Ass ^ct-arzneimittel^ (1 Df, Qd)
When commencing Actraphane 30 Novolet, the patient experienced the following unwanted symptoms/side effects:
  • Glycosylated Haemoglobin Increased
  • Loss Of Consciousness
  • Mental Disorder
  • Syncope
The 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 glycosylated haemoglobin increased, may become evident only after a product is in use by the general population.

Loss Of Consciousness, Mental Disorder, Syncope
This is a report of a 75-year-old male patient (weight: NA) from GERMANY. The patient developed the following symptoms/conditions: diabetes mellitus and was treated with Actraphane 30 Novolet (dosage: 32 Ie, Qd) starting NS. Concurrently used drugs:
  • Lyrica (2 Df, Qd)
  • Simvastatin (20 Mg, Qd)
  • Ass ^ct-arzneimittel^ (1 Df, Qd)
Soon after that, the consumer experienced the following side effects:
  • Loss Of Consciousness
  • Mental Disorder
  • Syncope
The patient was hospitalized. This opens a possibility that Actraphane 30 Novolet treatment could cause the above reactions, including loss of consciousness, and some male subjects may be more susceptible.

Loss Of Consciousness, Mental Disorder
A 75-year-old male patient (weight: NA) from GERMANY with the following symptoms/conditions: diabetes mellitus started Actraphane 30 Novolet treatment (dosage: NA) on NS. Soon after starting Actraphane 30 Novolet treatment, the subject experienced various side effects, including:
  • Loss Of Consciousness
  • Mental Disorder
Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Actraphane 30 Novolet.

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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.


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    More About Actraphane

    Side Effects reported to FDA: 26

    Actraphane safety alerts: No

    Reported deaths: 5

    Reported hospitalizations: 12

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