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Nicorandil Side Effects

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Common Nicorandil Side Effects


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

Chest Pain (4)
Fall (3)
Hypotension (3)
Bradycardia (3)
Dyspnoea (2)
Femur Fracture (2)
Abscess (2)
Atrial Fibrillation (2)
Blood Albumin Increased (2)
Therapeutic Response Unexpected (2)
Angina Pectoris (2)
Agitation (2)
Post Procedural Haemorrhage (2)
Monocyte Count Decreased (2)
Hyperkalaemia (2)
Oedema Peripheral (2)
Overdose (2)
Rhabdomyolysis (2)
Pneumonia (2)
Staphylococcal Infection (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.

Nicorandil Side Effects Reported to FDA



Nicorandil Side Effect Report#9824758
Urosepsis
This is a report of a 64-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Nicorandil (dosage: NA, start time: NS), combined with:
  • Salbutamol
  • Omeprazole
  • Amlodipine
  • Atorvastatin
  • Seretide
  • Aspirin
and developed a serious reaction and side effect(s): Urosepsis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nicorandil treatment in female patients, resulting in Urosepsis side effect. The patient was hospitalized.
Nicorandil Side Effect Report#8474911-4
Gastrointestinal Disorder, Pneumonia
This report suggests a potential Nicorandil (nicorandil) Gastrointestinal Disorder side effect(s) that can have serious consequences. A 61-year-old male patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: NA and used Nicorandil (nicorandil) (dosage: NA) starting
Apr 07, 2012. After starting Nicorandil (nicorandil) the patient began experiencing various side effects, including: Gastrointestinal Disorder, PneumoniaAdditional drugs used concurrently:
  • Lasix /0032601/ (furosemide)
  • Risedronate Sodium (17.5 Mg Weekly, Oral)
  • Aspirin
  • Famotidine
  • Lipitor
  • Aldactone
  • Carvedilol
  • Selbex (teprenone)
The patient was hospitalized. Although Nicorandil (nicorandil) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Gastrointestinal Disorder, may still occur.
Nicorandil Side Effect Report#8457622-0
Rhabdomyolysis
This Rhabdomyolysis problem was reported by a physician from United Kingdom. A 80-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: angina pectoris,blood cholesterol increased,poor peripheral circulation,gastrooesophageal reflux disease,localised infection. On
Apr 13, 2012 this consumer started treatment with Nicorandil (dosage: NA). The following drugs were being taken at the same time:
  • Simvastatin
  • Cilostazol (Indication: Circulation)
  • Omeprazole
  • Fusidic Acid
  • Flucloxacillin
When using Nicorandil, the patient experienced the following unwanted symptoms/side effects: RhabdomyolysisThe 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 Rhabdomyolysis, may become evident only after a product is in use by the general population.
Nicorandil Side Effect Report#8447209-8
Skin Exfoliation, Chest Pain, Atrial Fibrillation
This Skin Exfoliation side effect was reported by a health professional from Japan. A 79-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Nicorandil (nicorandil) (drug dosage: (df Oral)), which was initiated on
Apr 01, 2012. Concurrently used drugs:
  • Amiodarone Hcl ((df))
  • Diltiazem Hydrochloride ((df Oral))
  • Warfarin Sodium ((df Oral))
.After starting to take Nicorandil (nicorandil) the consumer reported adverse symptoms, such as: Skin Exfoliation, Chest Pain, Atrial FibrillationThese side effects may potentially be related to Nicorandil (nicorandil).
Nicorandil Side Effect Report#8422250-X
Fall, Tendon Rupture, Tendon Pain
This is a report of a 67-year-old female patient (weight: NA) from United Kingdom, suffering from the following health symptoms/conditions: NA, who was treated with Nicorandil (nicorandil) (dosage: NA, start time:
Mar 09, 2012), combined with:
  • Levothyroxine Sodium
  • Simvastatin
  • Dilzem Xl (diltiazem Hydrochloride)
  • Levofloxacin (500 Mg, Oral)
  • Clopidegrel
  • Prednisolone (Oral)
  • Movicol (polyethyl, Glyc. W/potas. Chlor./sod. Bicarb.)
  • Tropium (chlordiazepoxide Hydrochloride)
and developed a serious reaction and side effect(s): Fall, Tendon Rupture, Tendon Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nicorandil (nicorandil) treatment in female patients, resulting in Fall side effect. The patient was hospitalized.
Nicorandil Side Effect Report#8407240-5
Swelling Face
This report suggests a potential Nicorandil Swelling Face side effect(s) that can have serious consequences. A 72-year-old female patient (weight: NA) from Denmark was diagnosed with the following symptoms/conditions: NA and used Nicorandil (dosage: NA) starting
Mar 29, 2012. After starting Nicorandil the patient began experiencing various side effects, including: Swelling FaceAdditional drugs used concurrently:
  • Amlodipine
  • Valproic Acid
  • Omeprazole
  • Tramadol Hcl
  • Simvastatin
  • Quinine Sulfate
  • Moviprep
  • Doxycycline Hyclate (100 Mg; Po)
Although Nicorandil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Swelling Face, may still occur.
Nicorandil Side Effect Report#8376092-4
Fall, Agitation, Femur Fracture
This Fall problem was reported by a physician from Japan. A 89-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Apr 03, 2012 this consumer started treatment with Nicorandil (dosage: 10 Mg, Unk). The following drugs were being taken at the same time:
  • Exelon (4.5 Mg Daily)
  • Exelon (9 Mg, Daily)
  • Amlodipine Besylate (5 Mg, Unk)
When using Nicorandil, the patient experienced the following unwanted symptoms/side effects: Fall, Agitation, Femur FractureThe 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 Fall, may become evident only after a product is in use by the general population.
Nicorandil Side Effect Report#8303833-4
Fall, Femur Fracture, Agitation
This Fall side effect was reported by a physician from Japan. A 89-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Nicorandil (drug dosage: 10 Mg, Unk), which was initiated on
Mar 09, 2012. Concurrently used drugs:
  • Exelon (9 Mg, Daily)
  • Amlodipine (5 Mg, Unk)
  • Exelon (4.5 Mg Daily)
.After starting to take Nicorandil the consumer reported adverse symptoms, such as: Fall, Femur Fracture, AgitationThese side effects may potentially be related to Nicorandil. The patient was hospitalized.
Nicorandil Side Effect Report#8260896-2
No Adverse Event
This is a report of a 88-year-old female patient (weight: NA) from United Kingdom, suffering from the following health symptoms/conditions: angina pectoris,anaemia,infection, who was treated with Nicorandil (dosage: NA, start time:
Mar 30, 2012), combined with:
  • Ferrous Sulfate Tab
  • Teicoplanin
  • Ismn
  • Acetaminophen (1 G Qds)
  • Finasteride
  • Lansoprazole
  • Lactulose
  • Simvastatin (Nocte)
and developed a serious reaction and side effect(s): No Adverse Event after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nicorandil treatment in female patients, resulting in No Adverse Event side effect.
Nicorandil Side Effect Report#8240955-0
Vascular Pseudoaneurysm
This report suggests a potential Nicorandil Vascular Pseudoaneurysm side effect(s) that can have serious consequences. A 73-year-old male patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: atrial fibrillation,hypertension and used Nicorandil (dosage: Daily Dose 50 Mg) starting
Jan 01, 2007. After starting Nicorandil the patient began experiencing various side effects, including: Vascular PseudoaneurysmAdditional drugs used concurrently:
  • Nitrendipine (Daily Dose 10 Mg)
  • Aspirin (Daily Dose 100 Mg)
  • Pilsicainide Hydrochloride (Daily Dose 50 Mg)
The patient was hospitalized. Although Nicorandil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Vascular Pseudoaneurysm, may still occur.
Nicorandil Side Effect Report#8233640-2
Pain In Extremity
This Pain In Extremity problem was reported by a health professional from . A 65-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Dec 12, 2011 this consumer started treatment with Nicorandil (nicorandil) (dosage: NA). The following drugs were being taken at the same time:
  • Isosorbide Mononitrate
  • Tilidiem La (diltiazem Hydrochloride)
  • Omeprazole
  • Simvastatin (1 Dosage Forms (1 Dosage Forms,1 In 1 D),oral)
  • Levemir
  • Novolog
  • Clopidogrel
  • Levothyroxine Sodium
When using Nicorandil (nicorandil), the patient experienced the following unwanted symptoms/side effects: Pain In ExtremityAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pain In Extremity, may become evident only after a product is in use by the general population.
Nicorandil Side Effect Report#8223653-9
Rash Maculo-papular, Product Contamination Microbial, Pruritus, Paraesthesia, Papule, Rash Erythematous, Skin Warm
This Rash Maculo-papular side effect was reported by a health professional from United Kingdom. A 71-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Nicorandil (nicorandil) (drug dosage: NA), which was initiated on
Jan 11, 2012. Concurrently used drugs:
  • Teicoplanin (teicoplanin)
  • Aspirin
  • Nitrofurantoin
  • Magnesium L-aspartate Hydrochloride (magnesium Aspartate) (10 Millimol, 1 In 1 D, Oral)
  • Atorvastatin
  • Bisoprolol Fumarate
  • Ciprofloxacin (750 Mg, 2 In 1 D, Oral)
  • Piperacillin And Tazobactam (4.5 Gm, Intravenous Drip)
.After starting to take Nicorandil (nicorandil) the consumer reported adverse symptoms, such as: Rash Maculo-papular, Product Contamination Microbial, Pruritus, Paraesthesia, Papule, Rash Erythematous, Skin WarmThese side effects may potentially be related to Nicorandil (nicorandil).
Nicorandil Side Effect Report#8215457-8
Chest Pain, Electrocardiogram St Segment Elevation
This is a report of a patient (weight: NA) from India, suffering from the following health symptoms/conditions: NA, who was treated with Nicorandil (dosage: 2 Cc/hr, start time:
Oct 13, 2011), combined with:
  • Acetylsalicylic Acid Srt
  • Enoxaparin Sodium (60 Units Every Half An Hour)
  • Metalyse
  • Clopidogrel (plavix) (8 Tabs Administered)
  • Atorvastatin
and developed a serious reaction and side effect(s): Chest Pain, Electrocardiogram St Segment Elevation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nicorandil treatment in patients, resulting in Chest Pain side effect.
Nicorandil Side Effect Report#8164176-5
Blood Pressure Decreased, Dizziness, Incorrect Dose Administered, Heart Rate Decreased
This report suggests a potential Nicorandil (nicorandil) Blood Pressure Decreased side effect(s) that can have serious consequences. A 83-year-old female patient (weight: NA) from was diagnosed with the following symptoms/conditions: NA and used Nicorandil (nicorandil) (dosage: NA) starting
Oct 01, 2011. After starting Nicorandil (nicorandil) the patient began experiencing various side effects, including: Blood Pressure Decreased, Dizziness, Incorrect Dose Administered, Heart Rate DecreasedAdditional drugs used concurrently:
  • Bisoprolol Fumarate
  • Procoralan (ivabradine Hdyrochloride) ((15 Mg), Oral, 10 Mg (5 Mg, 2 In 1 D), Oral, 10 Mg (5 Mg, 2 In 1 D), Oral)
  • Procoralan (ivabradine Hdyrochloride) ((15 Mg), Oral, 10 Mg (5 Mg, 2 In 1 D), Oral, 10 Mg (5 Mg, 2 In 1 D), Oral)
  • Procoralan (ivabradine Hdyrochloride) ((15 Mg), Oral, 10 Mg (5 Mg, 2 In 1 D), Oral, 10 Mg (5 Mg, 2 In 1 D), Oral)
  • Monomil Xl (isosorbide Mononitrate)
The patient was hospitalized. Although Nicorandil (nicorandil) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Pressure Decreased, may still occur.
Nicorandil Side Effect Report#8136177-4
Mastoiditis, Ear Infection
This Mastoiditis problem was reported by a physician from France. A 72-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 26, 2012 this consumer started treatment with Nicorandil (dosage: NA). The following drugs were being taken at the same time:
  • Clopidogrel Bisulfate
  • Januvia
  • Perindopril Erbumine
  • Januvia
  • Bromazepam
  • Atenolol
  • Aspirin Lysine
  • Pantoprazole Sodium
When using Nicorandil, the patient experienced the following unwanted symptoms/side effects: Mastoiditis, Ear InfectionThe 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 Mastoiditis, may become evident only after a product is in use by the general population.
Nicorandil Side Effect Report#8031629-X
Renal Mass, Renal Cell Carcinoma
This Renal Mass side effect was reported by a health professional from United Kingdom. A 66-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Nicorandil (drug dosage: NA), which was initiated on
Aug 01, 2011. Concurrently used drugs:
  • Simvastatin
  • Humira (40 Mg, Biw)
  • Omeprazole
  • Methotrexate (5 Mg, Qw)
.After starting to take Nicorandil the consumer reported adverse symptoms, such as: Renal Mass, Renal Cell CarcinomaThese side effects may potentially be related to Nicorandil. The patient was hospitalized.
Nicorandil Side Effect Report#8028017-9
Altered State Of Consciousness
This is a report of a 83-year-old female patient (weight: NA) from Ireland, suffering from the following health symptoms/conditions: NA, who was treated with Nicorandil (nicorandil) (dosage: Po, start time:
Oct 26, 2011), combined with:
  • Vancomycin (Iv)
  • Levocetirizine Dihydrochloride (2.5 Mg;qd;po)
  • Streptococcus Faecalis (streptococcus Faecalis) (Po)
  • Cefepime (Iv)
and developed a serious reaction and side effect(s): Altered State Of Consciousness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nicorandil (nicorandil) treatment in female patients, resulting in Altered State Of Consciousness side effect.
Nicorandil Side Effect Report#8014044-4
Condition Aggravated, Crepitations, Exercise Tolerance Decreased, Rectal Haemorrhage, Bronchopneumonia, Dyspnoea, Diarrhoea, Fluid Overload, Oedema Peripheral
This report suggests a potential Nicorandil Condition Aggravated side effect(s) that can have serious consequences. A 77-year-old male patient (weight: NA) from United Kingdom was diagnosed with the following symptoms/conditions: NA and used Nicorandil (dosage: NA) starting
Aug 25, 2011. After starting Nicorandil the patient began experiencing various side effects, including: Condition Aggravated, Crepitations, Exercise Tolerance Decreased, Rectal Haemorrhage, Bronchopneumonia, Dyspnoea, Diarrhoea, Fluid Overload, Oedema PeripheralAdditional drugs used concurrently:
  • Adizem Xl
  • Aspirin
  • Glyceryl Trinitrate
  • Isosorbide Mononitrate
  • Alendronic Acid
  • Calcichew D3
  • Finasteride
  • Rituximab
Although Nicorandil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Condition Aggravated, may still occur.
Nicorandil Side Effect Report#7978325-2
Rhabdomyolysis, Multi-organ Failure
This Rhabdomyolysis problem was reported by a health professional from France. A 34-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: coronary artery disease. On
Oct 01, 2009 this consumer started treatment with Nicorandil (dosage: 10 Mg/day). The following drugs were being taken at the same time:
  • Cotrim (400 Mg/80 Mg 3 Tablets Per Week)
  • Cholecalciferol (880 Iu/day)
  • Colimycin (2 Sprayers Per Day)
  • Alpha-tocoferol (500 Mg/day)
  • Cyclosporine (170 Mg, Bid)
  • Colchicine (1 Mg, Qd)
  • Pancreatin Triple Strength Cap (250000 Iu/day)
  • Ferrous Ascorbate (66 Mg/day)
When using Nicorandil, the patient experienced the following unwanted symptoms/side effects: Rhabdomyolysis, Multi-organ FailureThe 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 Rhabdomyolysis, may become evident only after a product is in use by the general population.
Nicorandil Side Effect Report#7927006-X
Diarrhoea
This Diarrhoea side effect was reported by a consumer or non-health professional from United Kingdom. A 63-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Nicorandil (drug dosage: NA), which was initiated on
Aug 26, 2011. Concurrently used drugs:
  • Lansoprazole
  • Atenolol
  • Furosemide
  • Amitriptyline Hcl
  • Aspirin
  • Metformin Hcl
  • Hydrocortisone
  • Acetaminophen
.After starting to take Nicorandil the consumer reported adverse symptoms, such as: DiarrhoeaThese side effects may potentially be related to Nicorandil.
Nicorandil Side Effect Report#7801631-9
Embolism, Ischaemia, Thrombosis
This is a report of a 70-year-old female patient (weight: NA) from United Kingdom, suffering from the following health symptoms/conditions: NA, who was treated with Nicorandil (dosage: Unk, start time:
Dec 01, 2008), combined with:
  • Enbrel (25 Mg, 2x/week)
  • Aspirin (75 Mg, Unk)
  • Simvastatin (80 Mg, Unk)
  • Adizem (Unk)
  • Ramipril (10 Mg, Unk)
and developed a serious reaction and side effect(s): Embolism, Ischaemia, Thrombosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nicorandil treatment in female patients, resulting in Embolism side effect.
Nicorandil Side Effect Report#7779025-4
Gingival Bleeding
This report suggests a potential Nicorandil Gingival Bleeding side effect(s) that can have serious consequences. A male patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: ill-defined disorder and used Nicorandil (dosage: NA) starting
Sep 25, 2009. After starting Nicorandil the patient began experiencing various side effects, including: Gingival BleedingAdditional drugs used concurrently:
  • Potassium Chloride
  • Acetylsalicylic Acid W/aminoacetic Acid
  • Rivaroxaban
  • Rivaroxaban
  • Rosuvastatin
  • Magnesium Oxide
  • Aspirin
  • Famotidine
The patient was hospitalized. Although Nicorandil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Gingival Bleeding, may still occur.
Nicorandil Side Effect Report#7763583-X
Deafness Unilateral
This Deafness Unilateral problem was reported by a health professional from United Kingdom. A 73-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 01, 1998 this consumer started treatment with Nicorandil (dosage: NA). The following drugs were being taken at the same time:
  • Aspirin
  • Atorvastatin
  • Chlorpheniramine Maleate
  • Levothyroxine Sodium
  • Nitroglycerin
  • Lansoprazole
  • Warfarin Sodium
  • Metoprolol Tartrate
When using Nicorandil, the patient experienced the following unwanted symptoms/side effects: Deafness UnilateralAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Deafness Unilateral, may become evident only after a product is in use by the general population.
Nicorandil Side Effect Report#7761472-8
Torsade De Pointes, Arteriosclerosis Coronary Artery
This Torsade De Pointes side effect was reported by a health professional from France. A 67-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Nicorandil (nicorandil) (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Atenolol
  • Hexabrix
  • Molsidomine (molsidomine)
  • Bepridil (bepridil) (200 Mg (200 Mg, 1 In 1 D), Intracoronary)
.After starting to take Nicorandil (nicorandil) the consumer reported adverse symptoms, such as: Torsade De Pointes, Arteriosclerosis Coronary ArteryThese side effects may potentially be related to Nicorandil (nicorandil).
Nicorandil Side Effect Report#7755695-1
Intestinal Obstruction, Granulocytopenia, Ovarian Cancer Recurrent
This is a report of a female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: angina pectoris, who was treated with Nicorandil (dosage: NA, start time:
Jan 01, 2003), combined with:
  • Warfarin Sodium
  • Primperan Tab
  • Dai-kenchu-to
  • Doxorubicin Hcl (Course 1)
  • Aspirin
  • Betamethasone
  • Famotidine
  • Azunol
and developed a serious reaction and side effect(s): Intestinal Obstruction, Granulocytopenia, Ovarian Cancer Recurrent after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nicorandil treatment in female patients, resulting in Intestinal Obstruction side effect. The patient was hospitalized and became disabled.


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The appearance of Nicorandil 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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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.

    Nicorandil 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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