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Penfill Side Effects

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Common Penfill Side Effects


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

Hypoglycaemia (35)
Intentional Overdose (13)
Suicide Attempt (13)
Blood Glucose Fluctuation (11)
Anti-insulin Antibody Increased (8)
Blood Glucose Increased (7)
Hypoglycaemic Coma (7)
Anti-insulin Antibody (6)
Hepatic Function Abnormal (5)
Alanine Aminotransferase Increased (5)
Aspartate Aminotransferase Increased (5)
Oedema (5)
White Blood Cell Count Decreased (5)
Vomiting (4)
Neutrophil Count Decreased (4)
Anaemia (4)
Gastric Ulcer (4)
Altered State Of Consciousness (4)
Blood Pressure Decreased (4)
Injection Site Reaction (4)

➢ 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.

Penfill Side Effects Reported to FDA



Penfill Side Effect Report#8407980-8
Depression
This is a report of a 71-year-old male patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: NA, who was treated with Penfill 30r (insulin Human, Insulin Human Injection, Isophane) (dosage: NA, start time:
Apr 14, 2004), combined with:
  • Depas (etizolam)
  • Magmitt (magnesium Oxide)
  • Merislon (betahistine Mesilate)
  • Pletal (50 Mg Milligram(s), Bid, Oral)
  • Mucodyne (carbocisteine)
  • Basen (voglibose)
and developed a serious reaction and side effect(s): Depression after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Penfill 30r (insulin Human, Insulin Human Injection, Isophane) treatment in male patients, resulting in Depression side effect.
Penfill Side Effect Report#7134245-7
Acanthosis Nigricans, Injection Site Reaction
This report suggests a potential Penfill R Chu Acanthosis Nigricans side effect(s) that can have serious consequences. A 74-year-old male patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Penfill R Chu (dosage: 36 U, Qd) starting
Jan 01, 2005. After starting Penfill R Chu the patient began experiencing various side effects, including: Acanthosis Nigricans, Injection Site ReactionAdditional drugs used concurrently:
  • Penfill N Chu (12 U, Qd)
Although Penfill R Chu demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Acanthosis Nigricans, may still occur.
Penfill Side Effect Report#7128379-0
Anti-insulin Antibody Increased, Condition Aggravated, Diabetic Ketoacidotic Hyperglycaemic Coma, Hyperglycaemia, Hypoglycaemia, Psychiatric Symptom
This Anti-insulin Antibody Increased problem was reported by a physician from Japan. A 78-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On
Jan 01, 2002 this consumer started treatment with Penfill 30r Chu (dosage: Not Reported). The following drugs were being taken at the same time: NA. When using Penfill 30r Chu, the patient experienced the following unwanted symptoms/side effects: Anti-insulin Antibody Increased, Condition Aggravated, Diabetic Ketoacidotic Hyperglycaemic Coma, Hyperglycaemia, Hypoglycaemia, Psychiatric SymptomThe 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 Anti-insulin Antibody Increased, may become evident only after a product is in use by the general population.
Penfill Side Effect Report#7125001-4
Acanthosis Nigricans, Injection Site Reaction
This Acanthosis Nigricans side effect was reported by a physician from Japan. A 74-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Penfill R Chu (drug dosage: 36 U, Qd), which was initiated on
Jan 01, 2005. Concurrently used drugs:
  • Penfill N Chu (12 U, Qd)
.After starting to take Penfill R Chu the consumer reported adverse symptoms, such as: Acanthosis Nigricans, Injection Site ReactionThese side effects may potentially be related to Penfill R Chu.
Penfill Side Effect Report#7110155-6
Anti-insulin Antibody Increased, Hypoglycaemia Unawareness
This is a report of a 43-year-old female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: diabetes mellitus, who was treated with Penfill 30r Chu (dosage: Unk, Bid, start time: NS), combined with:
  • Novorapid Chu Flexpen (Unk)
  • Lispro Insulin
and developed a serious reaction and side effect(s): Anti-insulin Antibody Increased, Hypoglycaemia Unawareness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Penfill 30r Chu treatment in female patients, resulting in Anti-insulin Antibody Increased side effect.
Penfill Side Effect Report#7101775-3
Anti-insulin Antibody Increased, Condition Aggravated, Diabetic Ketoacidotic Hyperglycaemic Coma, Hyperglycaemia, Hypoglycaemia, Psychiatric Symptom
This report suggests a potential Penfill 30r Chu Anti-insulin Antibody Increased side effect(s) that can have serious consequences. A 78-year-old male patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Penfill 30r Chu (dosage: Not Reported) starting
Jan 01, 2002. After starting Penfill 30r Chu the patient began experiencing various side effects, including: Anti-insulin Antibody Increased, Condition Aggravated, Diabetic Ketoacidotic Hyperglycaemic Coma, Hyperglycaemia, Hypoglycaemia, Psychiatric SymptomAdditional drugs used concurrently: NA.The patient was hospitalized. Although Penfill 30r Chu demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anti-insulin Antibody Increased, may still occur.
Penfill Side Effect Report#6571030-9
Altered State Of Consciousness, Epilepsy, Hypoglycaemia, Retrograde Amnesia
This Altered State Of Consciousness problem was reported by a physician from Japan. A 39-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 1 diabetes mellitus. On NS this consumer started treatment with Penfill N Chu (dosage: Not Reported). The following drugs were being taken at the same time: NA. When using Penfill N Chu, the patient experienced the following unwanted symptoms/side effects: Altered State Of Consciousness, Epilepsy, Hypoglycaemia, Retrograde AmnesiaThe 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 Altered State Of Consciousness, may become evident only after a product is in use by the general population.
Penfill Side Effect Report#6567929-X
Oedema, Weight Increased
This Oedema side effect was reported by a physician from Japan. A 61-year-old female patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Penfill 30r Chu (drug dosage: Unk U, Unk), which was initiated on
Sep 01, 2004. Concurrently used drugs:
  • Actos (/po)
.After starting to take Penfill 30r Chu the consumer reported adverse symptoms, such as: Oedema, Weight IncreasedThese side effects may potentially be related to Penfill 30r Chu. The patient was hospitalized.
Penfill Side Effect Report#6550345-4
Altered State Of Consciousness, Epilepsy, Hypoglycaemia, Retrograde Amnesia
This is a report of a 39-year-old male patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: type 1 diabetes mellitus, who was treated with Penfill N Chu (dosage: Not Reported, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Altered State Of Consciousness, Epilepsy, Hypoglycaemia, Retrograde Amnesia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Penfill N Chu treatment in male patients, resulting in Altered State Of Consciousness side effect. The patient was hospitalized.
Penfill Side Effect Report#6489625-X
Hepatic Function Abnormal
This report suggests a potential Penfill R Chu Hepatic Function Abnormal side effect(s) that can have serious consequences. A 55-year-old female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Penfill R Chu (dosage: Sliding Scale) starting
Sep 30, 2009. After starting Penfill R Chu the patient began experiencing various side effects, including: Hepatic Function AbnormalAdditional drugs used concurrently:
  • Penfill N Chu (Sliding Scale)
  • Novolin R ((6+6+2+0) Iu, Qd)
  • Novolin N ((0+0+0+5) Iu, Qd)
  • Magmitt (990 Mg, Qd)
  • Alosenn /00476901/ (0.5 G, Qd)
The patient was hospitalized. Although Penfill R Chu demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatic Function Abnormal, may still occur.
Penfill Side Effect Report#6443449-8
Hepatic Function Abnormal
This Hepatic Function Abnormal problem was reported by a physician from Japan. A 55-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On
Sep 30, 2009 this consumer started treatment with Penfill R Chu (dosage: Sliding Scale). The following drugs were being taken at the same time:
  • Penfill N Chu (Sliding Scale)
  • Novolin R ((6+6+2+0) Iu, Qd)
  • Novolin N ((0+0+0+5) Iu, Qd)
  • Magmitt (990 Mg, Qd)
  • Alosenn /00476901/ (0.5 G, Qd)
When using Penfill R Chu, the patient experienced the following unwanted symptoms/side effects: Hepatic Function AbnormalThe 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 Hepatic Function Abnormal, may become evident only after a product is in use by the general population.
Penfill Side Effect Report#6412125-X
Altered State Of Consciousness, Hypoglycaemic Coma
This Altered State Of Consciousness side effect was reported by a consumer or non-health professional from Japan. A 60-year-old female patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Penfill 50r Chu (drug dosage: 16 Iu, Qd), which was initiated on
May 16, 2008. Concurrently used drugs: NA..After starting to take Penfill 50r Chu the consumer reported adverse symptoms, such as: Altered State Of Consciousness, Hypoglycaemic ComaThese side effects may potentially be related to Penfill 50r Chu. The patient was hospitalized.
Penfill Side Effect Report#6368311-0
Altered State Of Consciousness, Hypoglycaemic Coma
This is a report of a 60-year-old female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Penfill 50r Chu (dosage: 16 Iu, Qd, start time:
May 16, 2008), combined with: NA. and developed a serious reaction and side effect(s): Altered State Of Consciousness, Hypoglycaemic Coma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Penfill 50r Chu treatment in female patients, resulting in Altered State Of Consciousness side effect. The patient was hospitalized.
Penfill Side Effect Report#6335015-X
Hypoglycaemia, Hypoglycaemic Coma, Intentional Overdose, Suicide Attempt
This report suggests a potential Penfill 30r Chu Hypoglycaemia side effect(s) that can have serious consequences. A female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Penfill 30r Chu (dosage: 10+12+0 Iu, Qd) starting
Aug 27, 2001. After starting Penfill 30r Chu the patient began experiencing various side effects, including: Hypoglycaemia, Hypoglycaemic Coma, Intentional Overdose, Suicide AttemptAdditional drugs used concurrently: NA.The patient was hospitalized. Although Penfill 30r Chu demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypoglycaemia, may still occur.
Penfill Side Effect Report#6301557-6
Hypoglycaemia, Suicide Attempt
This Hypoglycaemia problem was reported by a physician from Japan. A 37-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: type 1 diabetes mellitus. On NS this consumer started treatment with Penfill N Chu (dosage: 13 Iu, Qd). The following drugs were being taken at the same time: NA. When using Penfill N Chu, the patient experienced the following unwanted symptoms/side effects: Hypoglycaemia, Suicide AttemptThe 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 Hypoglycaemia, may become evident only after a product is in use by the general population.
Penfill Side Effect Report#6273527-8
Hypoglycaemia, Suicide Attempt
This Hypoglycaemia side effect was reported by a physician from Japan. A 37-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 1 diabetes mellitus.The patient was prescribed Penfill N Chu (drug dosage: Unk Iu, Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Penfill N Chu the consumer reported adverse symptoms, such as: Hypoglycaemia, Suicide AttemptThese side effects may potentially be related to Penfill N Chu. The patient was hospitalized.
Penfill Side Effect Report#6218171-3
Blood Glucose Increased, Injection Site Reaction
This is a report of a 50-year-old male patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Penfill R Chu (dosage: 4-4-4, start time:
Aug 14, 2003), combined with:
  • Penfill 30r Chu (14-18 Iu)
  • Lantus
  • Metformin Hydrochloride (500 Mg, Qd)
  • Alotec (5 Mg, Unk)
and developed a serious reaction and side effect(s): Blood Glucose Increased, Injection Site Reaction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Penfill R Chu treatment in male patients, resulting in Blood Glucose Increased side effect. The patient was hospitalized.
Penfill Side Effect Report#6139560-1
Anti-insulin Antibody, Autoantibody Positive, Bladder Perforation, Blood Glucose Fluctuation
This report suggests a potential Penfill 30r Chu Anti-insulin Antibody side effect(s) that can have serious consequences. A 58-year-old female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Penfill 30r Chu (dosage: Unk, Unk) starting
Jan 01, 2001. After starting Penfill 30r Chu the patient began experiencing various side effects, including: Anti-insulin Antibody, Autoantibody Positive, Bladder Perforation, Blood Glucose FluctuationAdditional drugs used concurrently: NA.The patient was hospitalized. Although Penfill 30r Chu demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anti-insulin Antibody, may still occur.
Penfill Side Effect Report#6105104-3
Anti-insulin Antibody Increased, Hypoglycaemia
This Anti-insulin Antibody Increased problem was reported by a physician from Japan. A 70-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus. On
Mar 01, 2006 this consumer started treatment with Penfill R Chu (dosage: NA). The following drugs were being taken at the same time:
  • Penfill 30r Chu
  • Humalog
  • Lantus
When using Penfill R Chu, the patient experienced the following unwanted symptoms/side effects: Anti-insulin Antibody Increased, 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 Anti-insulin Antibody Increased, may become evident only after a product is in use by the general population.
Penfill Side Effect Report#5972661-7
Anti-insulin Antibody, Hypoglycaemia
This Anti-insulin Antibody side effect was reported by a physician from Japan. A 68-year-old male patient (weight:NA) experienced the following symptoms/conditions: type 2 diabetes mellitus.The patient was prescribed Penfill 30r Chu (drug dosage: (20-0-10)), which was initiated on
Dec 03, 2007. Concurrently used drugs:
  • Penfill R Chu (Not Reported)
  • Penfill 10r Chu (Not Reported)
  • Penfill N Chu (Not Reported)
  • Penfill R Chu ((4-4-2))
  • Humalog ((4-4-2))
.After starting to take Penfill 30r Chu the consumer reported adverse symptoms, such as: Anti-insulin Antibody, HypoglycaemiaThese side effects may potentially be related to Penfill 30r Chu. The patient was hospitalized.
Penfill Side Effect Report#5951716-7
Hypoglycaemic Coma, Intentional Overdose, Suicide Attempt
This is a report of a 65-year-old male patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Penfill 50r Chu (dosage: NA, start time:
Oct 01, 2003), combined with:
  • Penfill R Chu
  • Insulin
  • Sinlestal (750 Mg, Qd)
  • Penfill 30r Chu
and developed a serious reaction and side effect(s): Hypoglycaemic Coma, Intentional Overdose, Suicide Attempt after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Penfill 50r Chu treatment in male patients, resulting in Hypoglycaemic Coma side effect.
Penfill Side Effect Report#5795866-7
Anorexia Nervosa, Hypoglycaemia
This report suggests a potential Penfill 30r Chu Anorexia Nervosa side effect(s) that can have serious consequences. A female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: type 2 diabetes mellitus and used Penfill 30r Chu (dosage: NA) starting
May 01, 2007. After starting Penfill 30r Chu the patient began experiencing various side effects, including: Anorexia Nervosa, HypoglycaemiaAdditional drugs used concurrently:
  • Novorapid Chu
  • Glufast (30 Mg, Qd)
The patient was hospitalized. Although Penfill 30r Chu demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anorexia Nervosa, may still occur.
Penfill Side Effect Report#5788726-9
Hepatic Function Abnormal
This Hepatic Function Abnormal problem was reported by a physician from Japan. A 57-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: hyperglycaemia. On
Oct 15, 2003 this consumer started treatment with Penfill N Chu (dosage: 8 Iu, Qd). The following drugs were being taken at the same time:
  • Penfill R Chu (24 Iu, Qd)
  • Humalog (24 U, Qd)
  • Humalog
  • Humacart N
  • Flomox
  • Cefaclor
When using Penfill N Chu, the patient experienced the following unwanted symptoms/side effects: Hepatic Function AbnormalAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hepatic Function Abnormal, may become evident only after a product is in use by the general population.
Penfill Side Effect Report#5781391-6
Blood Glucose Fluctuation, Hypoglycaemia
This Blood Glucose Fluctuation side effect was reported by a physician from Japan. A 62-year-old female patient (weight:NA) experienced the following symptoms/conditions: latent autoimmune diabetes in adults.The patient was prescribed Penfill 30r Chu (drug dosage: 20-0-10 Iu, Qd), which was initiated on
May 25, 2007. Concurrently used drugs: NA..After starting to take Penfill 30r Chu the consumer reported adverse symptoms, such as: Blood Glucose Fluctuation, HypoglycaemiaThese side effects may potentially be related to Penfill 30r Chu. The patient was hospitalized.
Penfill Side Effect Report#5775341-6
Anorexia Nervosa, Hypoglycaemia
This is a report of a female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: type 2 diabetes mellitus, who was treated with Penfill 30r Chu (dosage: NA, start time:
May 01, 2007), combined with:
  • Novorapid Chu
  • Glufast (30 Mg, Qd)
and developed a serious reaction and side effect(s): Anorexia Nervosa, Hypoglycaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Penfill 30r Chu treatment in female patients, resulting in Anorexia Nervosa side effect. The patient was hospitalized.


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The appearance of Penfill 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.

    Penfill 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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    Side Effects reported to FDA: 103

    Penfill safety alerts: No

    Reported deaths: 1

    Reported hospitalizations: 27

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