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Abdominal Discomfort (1)
Abdominal Discomfort And Diarrhoea (1)
Diarrhoea (1)
Epigastric Pain (1)
Swelling Of Feet (1)
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Actraphane Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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B-cell Lymphoma, Bone Sarcoma (8313528-9)
on Apr 17, 2012 Female from GERMANY , 90 years of age, weighting 163.1 lb, was diagnosed with
  • type 2 diabetes mellitus
and was treated with Actraphane 30 Penfill. Directly after, patient experienced the unwanted or unexpected Actraphane side effects: b-cell lymphoma, bone sarcoma. Actraphane 30 Penfill dosage: N/A.
Associated medications used:
  • Novodigal Mite (Unk, Qd)
  • Pentaerythritol Tetranitrate (Unk, Bid)
  • Herz Ass 100 (Unk, Qd)
  • Losartan Comp. 100/25 (Unk)
Patient was hospitalized.

Gastrointestinal Carcinoma, Diabetic Foot (8206766-7)
Patient was taking Actraphane Mc. Patient felt the following Actraphane side effects: gastrointestinal carcinoma, diabetic foot on Mar 05, 2012 from GERMANY Additional patient health information: Male , 67 years of age, . Actraphane Mc dosage: N/A.
Multiple prescriptions taken:
  • Metformin Hydrochloride
Patient was hospitalized.

Pneumocystis Jiroveci Pneumonia, Hiv Infection (8197790-1)
Adverse event was reported on Mar 06, 2012 by a Male taking Actraphane (Dosage: Unk-07dec10,92iu 08dec10-14jun11,82iu 15jun-17dec11,92iu/u 18-25dec11,80iu/u 28dec11-07jan12) was diagnosed with
  • type 2 diabetes mellitus
and. Location: UNITED STATES , 62 years of age, After Actraphane was administered, patient encountered several Actraphane side effects: pneumocystis jiroveci pneumonia, hiv infection. Patient was hospitalized.

Gastric Ulcer, Gastric Haemorrhage, Vomiting, Hypoacusis, Haemoglobin, Haematemesis, Helicobacter Test Positive, Urinary Tract Infection, Wound (8184647-5)
on Mar 01, 2012 Female from GERMANY , weighting 187.4 lb, was treated with Actraphane. Directly after, patient experienced the unwanted or unexpected Actraphane side effects: gastric ulcer, gastric haemorrhage, vomiting, hypoacusis, haemoglobin, haematemesis, helicobacter test positive, urinary tract infection, wound. Actraphane dosage: 30 Anz.
Associated medications used:
  • Calcium D3 (2 Anz)
  • Hydrochlorothiazide (12.5 Nr)
  • Novalgin (4 Anz)
  • Pradaxa
Patient was hospitalized.


Pneumocystis Jiroveci Pneumonia, Hiv Infection (8174297-9)
on Feb 27, 2012 Male from UNITED STATES , 62 years of age, was diagnosed with
  • type 2 diabetes mellitus
and was treated with Actraphane. Patient felt the following Actraphane side effects: pneumocystis jiroveci pneumonia, hiv infection. Actraphane dosage: Unk-07dec10,92iu 08dec10-14jun11,82iu 15jun11-unk,92iu/u. Patient was hospitalized.

Pericardial Haemorrhage (8153279-7)
Patient was taking Actraphane Hm 30/70. After Actraphane was administered, patient encountered several Actraphane side effects: pericardial haemorrhage on Feb 07, 2012 from GERMANY Additional patient health information: Female , 76 years of age, weighting 164.0 lb, . Actraphane Hm 30/70 dosage: N/A.
Multiple concurrent drugs taken:
  • Vemurafenib (Last Dose Prior To Sae:30 Nov 2011)
  • Perindopril Erbumine
  • Aspirin
  • Xipamid
  • Falithrom
  • Concor 5
  • Pentaerythritol Tetranitrate
  • Torsemide
Patient was hospitalized.

Dialysis (7745721-8)
Adverse event was reported on Aug 19, 2011 by a Male taking Actraphane (insulin Human, Insulin Human Injection, Isophane) (Dosage: N/A) . Location: SOUTH AFRICA , 33 years of age, Directly after, patient experienced the unwanted or unexpected Actraphane side effects: dialysis.
Associated medications used:
  • Actos


Hyperglycaemia, Haemolytic Anaemia, Anaemia Haemolytic Autoimmune (7531458-7)
on May 06, 2011 Male from GERMANY , 77 years of age, weighting 149.9 lb, was treated with Actraphane 30 Penfill. Patient felt the following Actraphane side effects: hyperglycaemia, haemolytic anaemia, anaemia haemolytic autoimmune. Actraphane 30 Penfill dosage: Unk. Patient was hospitalized.

Anaemia Haemolytic Autoimmune, Haemolytic Anaemia, Hyperglycaemia (7481336-7)
on May 06, 2011 Male from GERMANY , 77 years of age, weighting 149.9 lb, was diagnosed with
  • type 2 diabetes mellitus
and was treated with Actraphane 30 Penfill. After Actraphane was administered, patient encountered several Actraphane side effects: anaemia haemolytic autoimmune, haemolytic anaemia, hyperglycaemia. Actraphane 30 Penfill dosage: Unk. Patient was hospitalized.

Hypertension, Shock Hypoglycaemic (7025015-9)
Patient was taking Actraphane 30 Penfill. Directly after, patient experienced the unwanted or unexpected Actraphane side effects: hypertension, shock hypoglycaemic on Sep 23, 2010 from GERMANY Additional patient health information: Male , 82 years of age, weighting 169.8 lb, was diagnosed with
  • type 2 diabetes mellitus
and. Actraphane 30 Penfill dosage: 56 Iu, Qd.
Associated medications used:
  • 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)
Patient was hospitalized.

Blood Glucose Decreased, Blood Glucose Increased, Cardiac Arrest, Delirium Tremens, Diarrhoea, Fall, Hypoglycaemia, Renal Failure, Rhabdomyolysis (6962015-9)
Adverse event was reported on Aug 26, 2010 by a Male taking Actraphane 30 Penfill (Dosage: 45 Iu, Bid) was diagnosed with
  • type 2 diabetes mellitus
and. Location: GERMANY , 74 years of age, weighting 275.6 lb, Patient felt the following Actraphane side effects: blood glucose decreased, blood glucose increased, cardiac arrest, delirium tremens, diarrhoea, fall, hypoglycaemia, renal failure, rhabdomyolysis. Patient was hospitalized.

Arrhythmia (6779205-0)
on Jun 09, 2010 Female from GERMANY , 54 years of age, was diagnosed with
  • diabetes mellitus
and was treated with Actraphane 30 Innolet. After Actraphane was administered, patient encountered several Actraphane side effects: arrhythmia. Actraphane 30 Innolet dosage: Unk.
Multiple concurrent drugs taken:
  • Simvastatin
  • Metoprolol Succinate
  • Amlodipin /00972401/
Patient was hospitalized.

Arrhythmia (6745804-5)
on May 17, 2010 Female from GERMANY , 54 years of age, was diagnosed with
  • diabetes mellitus
and was treated with Actraphane 30 Innolet. Directly after, patient experienced the unwanted or unexpected Actraphane side effects: arrhythmia. Actraphane 30 Innolet dosage: Unk.
Associated medications used:
  • Simvastatin
  • Metoprolol Succinate
  • Amlodipin /00972401/
Patient was hospitalized.

Anaemia Haemolytic Autoimmune, Haemolytic Anaemia, Hyperglycaemia (6607764-7)
Patient was taking Actraphane 30 Penfill. Patient felt the following Actraphane side effects: anaemia haemolytic autoimmune, haemolytic anaemia, hyperglycaemia on Feb 16, 2010 from GERMANY Additional patient health information: Male , 77 years of age, weighting 149.9 lb, was diagnosed with
  • type 2 diabetes mellitus
and. Actraphane 30 Penfill dosage: Unk. Patient was hospitalized.

Anaemia Haemolytic Autoimmune (6500475-8)
Adverse event was reported on Dec 07, 2009 by a Male taking Actraphane 30 Penfill (Dosage: Unk) . Location: GERMANY , 77 years of age, weighting 149.9 lb, After Actraphane was administered, patient encountered several Actraphane side effects: anaemia haemolytic autoimmune. Patient was hospitalized.

Blood Glucose Decreased, Blood Glucose Increased, Cardiac Arrest, Delirium Tremens, Diarrhoea, Fall, Hypoglycaemia, Renal Failure, Rhabdomyolysis (6270188-9)
on Jul 09, 2009 Male from GERMANY , 74 years of age, weighting 275.6 lb, was diagnosed with
  • type 2 diabetes mellitus
and was treated with Actraphane 30 Penfill. Directly after, patient experienced the unwanted or unexpected Actraphane side effects: blood glucose decreased, blood glucose increased, cardiac arrest, delirium tremens, diarrhoea, fall, hypoglycaemia, renal failure, rhabdomyolysis. Actraphane 30 Penfill dosage: 45 Iu, Bid. Patient was hospitalized.

Blood Glucose Decreased, Blood Glucose Increased, Cardiac Arrest, Delirium Tremens, Diarrhoea, Fall, Hypoglycaemia, Renal Failure, Rhabdomyolysis (6244770-9)
on Jun 17, 2009 Male from GERMANY , 74 years of age, weighting 275.6 lb, was diagnosed with
  • type 2 diabetes mellitus
and was treated with Actraphane 30 Penfill. Patient felt the following Actraphane side effects: blood glucose decreased, blood glucose increased, cardiac arrest, delirium tremens, diarrhoea, fall, hypoglycaemia, renal failure, rhabdomyolysis. Actraphane 30 Penfill dosage: 45 Iu, Bid. Patient was hospitalized.

Hypertension, Shock Hypoglycaemic (6146134-5)
Patient was taking Actraphane 30 Penfill. After Actraphane was administered, patient encountered several Actraphane side effects: hypertension, shock hypoglycaemic on Apr 02, 2009 from GERMANY Additional patient health information: Male , 82 years of age, weighting 169.8 lb, was diagnosed with
  • type 2 diabetes mellitus
and. Actraphane 30 Penfill dosage: 56 Iu, Qd.
Multiple concurrent drugs taken:
  • 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)
Patient was hospitalized.

Alcohol Withdrawal Syndrome, Blood Glucose Decreased, Blood Glucose Increased, Cardiac Arrest, Diarrhoea, Fall, Hypoglycaemia, Renal Failure, Rhabdomyolysis (6111113-0)
Adverse event was reported on Feb 27, 2009 by a Male taking Actraphane 30 Penfill (Dosage: 45 Iu, Bid) was diagnosed with
  • type 2 diabetes mellitus
and. Location: GERMANY , 74 years of age, weighting 275.6 lb, Directly after, patient experienced the unwanted or unexpected Actraphane side effects: alcohol withdrawal syndrome, blood glucose decreased, blood glucose increased, cardiac arrest, diarrhoea, fall, hypoglycaemia, renal failure, rhabdomyolysis. Patient was hospitalized.

Hypertension, Shock Hypoglycaemic (6096627-4)
on Feb 16, 2009 Male from GERMANY , 82 years of age, weighting 169.8 lb, was diagnosed with
  • type 2 diabetes mellitus
and was treated with Actraphane 30 Penfill. Patient felt the following Actraphane side effects: hypertension, shock hypoglycaemic. Actraphane 30 Penfill dosage: 56 Iu, Qd.
Multiple prescriptions taken:
  • 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)
Patient was hospitalized.

Mental Disorder, Nausea, Syncope, Vertigo, Vomiting (4950456-0)
on Jan 20, 2006 Male from GERMANY , 75 years of age, weighting 180.8 lb, was diagnosed with
  • diabetes mellitus
and was treated with Actraphane 30 Novolet. After Actraphane was administered, patient encountered several Actraphane side effects: mental disorder, nausea, syncope, vertigo, vomiting. Actraphane 30 Novolet dosage: 32 Ie, Qd.
Multiple concurrent drugs taken:
  • Lyrica (2 Df, Qd)
  • Simvastatin (20 Mg, Qd)
  • Ass ^ct-arzneimittel^ (1 Df, Qd)
Patient was hospitalized.

Glycosylated Haemoglobin Increased, Loss Of Consciousness, Mental Disorder, Syncope (4917805-0)
Patient was taking Actraphane 30 Novolet. Directly after, patient experienced the unwanted or unexpected Actraphane side effects: glycosylated haemoglobin increased, loss of consciousness, mental disorder, syncope on Jan 20, 2006 from GERMANY Additional patient health information: Male , 75 years of age, weighting 180.8 lb, was diagnosed with
  • diabetes mellitus
and. Actraphane 30 Novolet dosage: 32 Ie, Qd.
Associated medications used:
  • Lyrica (2 Df, Qd)
  • Simvastatin (20 Mg, Qd)
  • Ass ^ct-arzneimittel^ (1 Df, Qd)
Patient was hospitalized.

Loss Of Consciousness, Mental Disorder, Syncope (4898158-3)
Adverse event was reported on Jan 20, 2006 by a Male taking Actraphane 30 Novolet (Dosage: 32 Ie, Qd) was diagnosed with
  • diabetes mellitus
and. Location: GERMANY , 75 years of age, weighting 180.8 lb, Patient felt the following Actraphane side effects: loss of consciousness, mental disorder, syncope.
Multiple prescriptions taken:
  • Lyrica (2 Df, Qd)
  • Simvastatin (20 Mg, Qd)
  • Ass ^ct-arzneimittel^ (1 Df, Qd)
Patient was hospitalized.

Loss Of Consciousness, Mental Disorder (4894808-6)
on Jan 20, 2006 Male from GERMANY , 75 years of age, was diagnosed with
  • diabetes mellitus
and was treated with Actraphane 30 Novolet. After Actraphane was administered, patient encountered several Actraphane side effects: loss of consciousness, mental disorder. Actraphane 30 Novolet dosage: N/A. Patient was hospitalized.

Angioneurotic Oedema, Aphthous Stomatitis (4594748-6)
on Feb 17, 2005 Female from , 55 years of age, weighting 154.3 lb, was diagnosed with
  • diabetes mellitus non-insulin-dependent
and was treated with Actraphane 30 Penfill. Directly after, patient experienced the unwanted or unexpected Actraphane side effects: angioneurotic oedema, aphthous stomatitis. Actraphane 30 Penfill dosage: 14 Iu, Qd.
Associated medications used:
  • Metformin Hcl (1000 Mg, Bid)


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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Actraphane Information

More About Actraphane

Side Effects reported to FDA: 25. View Actraphane Adverse Reports

Actraphane safety alerts: No

Reported deaths: 5

Reported hospitalizations: 12

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