Common Duodart Side Effects


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

Dizziness (7)
Malaise (6)
Dyspnoea (4)
Fall (3)
Hypersensitivity (3)
Rash Pruritic (3)
Myalgia (3)
Hypotension (2)
Bronchospasm (2)
Loss Of Consciousness (2)
Hepatic Enzyme Increased (2)
Syncope (2)
Product Quality Issue (2)
Tachycardia (2)
Urinary Retention (2)
Pyrexia (2)
Nervousness (1)
Nausea (1)
Nasal Dryness (1)
Myocardial Ischaemia (1)

➢ 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.

Duodart Side Effects Reported to FDA



Duodart Side Effect Report#9894292
Prurigo, Eczema
This is a report of a 81-year-old male patient (weight: NA) from ES, suffering from the following health symptoms/conditions: neoplasm prostate, who was treated with Duodart (dosage: NA, start time:
Oct 17, 2013), combined with: NA. and developed a serious reaction and side effect(s): Prurigo, Eczema after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Duodart treatment in male patients, resulting in Prurigo side effect.
Duodart Side Effect Report#9832824
Loss Of Consciousness, Vertigo, Breast Pain, Fall
This report suggests a potential Duodart Loss Of Consciousness side effect(s) that can have serious consequences. A 75-year-old male patient (weight: NA) from RO was diagnosed with the following symptoms/conditions: benign prostatic hyperplasia,hypertension and used Duodart (dosage: 1cap Per Day) starting
Jun 13, 2013. After starting Duodart the patient began experiencing various side effects, including: Loss Of Consciousness, Vertigo, Breast Pain, FallAdditional drugs used concurrently:
  • Prestarium
Although Duodart demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Loss Of Consciousness, may still occur.
Duodart Side Effect Report#9808084
Dizziness, Myalgia, Gastric Disorder, Blood Pressure Increased
This Dizziness problem was reported by a pharmacist from DE. A 78-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Dec 12, 2013 this consumer started treatment with Duodart (dosage: NA). The following drugs were being taken at the same time:
  • Phenprocoumon
  • Acetylsalicylic Acid
  • Bisoprolol
  • Valsartan / Hydrochlorothiazide
  • Pantoprazol
  • Ezetimibe
  • Simvastatine
When using Duodart, the patient experienced the following unwanted symptoms/side effects: Dizziness, Myalgia, Gastric Disorder, Blood Pressure IncreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dizziness, may become evident only after a product is in use by the general population.
Duodart Side Effect Report#9788921
Cardiomyopathy, Dyspnoea
This Cardiomyopathy side effect was reported by a health professional from AU. A 72-year-old male patient (weight:NA) experienced the following symptoms/conditions: benign prostatic hyperplasia.The patient was prescribed Duodart (drug dosage: NA), which was initiated on 201212. Concurrently used drugs:
  • Candesartan
  • Bisoprolol
  • Irbesartan
  • Frusemide
  • Glyceryl Trinitrate Spray
.After starting to take Duodart the consumer reported adverse symptoms, such as: Cardiomyopathy, DyspnoeaThese side effects may potentially be related to Duodart. The patient was hospitalized.
Duodart Side Effect Report#9750231
Erectile Dysfunction, Hypertension
This is a report of a 63-year-old male patient (weight: NA) from ES, suffering from the following health symptoms/conditions: benign prostatic hyperplasia, who was treated with Duodart (dosage: 1u Per Day, start time:
Oct 08, 2013), combined with: NA. and developed a serious reaction and side effect(s): Erectile Dysfunction, Hypertension after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Duodart treatment in male patients, resulting in Erectile Dysfunction side effect.
Duodart Side Effect Report#9723650
Loss Of Consciousness, Syncope, Fall, Injury
This report suggests a potential Duodart Loss Of Consciousness side effect(s) that can have serious consequences. A 73-year-old male patient (weight: NA) from IL was diagnosed with the following symptoms/conditions: NA and used Duodart (dosage: NA) starting NS. After starting Duodart the patient began experiencing various side effects, including: Loss Of Consciousness, Syncope, Fall, InjuryAdditional drugs used concurrently: NA.The patient was hospitalized. Although Duodart demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Loss Of Consciousness, may still occur.
Duodart Side Effect Report#9684260
Deafness
This Deafness problem was reported by a health professional from PH. A 73-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: benign prostatic hyperplasia. On 201307 this consumer started treatment with Duodart (dosage: NA). The following drugs were being taken at the same time: NA. When using Duodart, the patient experienced the following unwanted symptoms/side effects: DeafnessAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Deafness, may become evident only after a product is in use by the general population.
Duodart Side Effect Report#9449268
Polymyalgia Rheumatica
This Polymyalgia Rheumatica side effect was reported by a health professional from NO. A 74-year-old male patient (weight:NA) experienced the following symptoms/conditions: benign prostatic hyperplasia.The patient was prescribed Duodart (drug dosage: 1cap Per Day), which was initiated on NS. Concurrently used drugs: NA..After starting to take Duodart the consumer reported adverse symptoms, such as: Polymyalgia RheumaticaThese side effects may potentially be related to Duodart.
Duodart Side Effect Report#9391730
Oesophageal Pain, Oesophageal Irritation, Pain, Gastrooesophageal Reflux Disease, Product Quality Issue
This is a report of a 52-year-old male patient (weight: NA) from AU, suffering from the following health symptoms/conditions: nocturia, who was treated with Duodart (dosage: 1cap At Night, start time:
Jun 11, 2013), combined with: NA. and developed a serious reaction and side effect(s): Oesophageal Pain, Oesophageal Irritation, Pain, Gastrooesophageal Reflux Disease, Product Quality Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Duodart treatment in male patients, resulting in Oesophageal Pain side effect.
Duodart Side Effect Report#9378210
Faeces Discoloured, Faeces Soft, Anorectal Discomfort, Defaecation Urgency, Weight Decreased, Food Interaction
This report suggests a potential Duodart Faeces Discoloured side effect(s) that can have serious consequences. A 78-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: prostatic disorder and used Duodart (dosage: NA) starting
Sep 22, 2011. After starting Duodart the patient began experiencing various side effects, including: Faeces Discoloured, Faeces Soft, Anorectal Discomfort, Defaecation Urgency, Weight Decreased, Food InteractionAdditional drugs used concurrently:
  • Metformin
Although Duodart demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Faeces Discoloured, may still occur.
Duodart Side Effect Report#9373353
Dizziness, Hypotension, Palpitations, Fatigue, Headache
This Dizziness problem was reported by a pharmacist from IT. A 82-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: benign prostatic hyperplasia. On
Mar 22, 2013 this consumer started treatment with Duodart (dosage: 1cap Per Day). The following drugs were being taken at the same time: NA. When using Duodart, the patient experienced the following unwanted symptoms/side effects: Dizziness, Hypotension, Palpitations, Fatigue, HeadacheAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dizziness, may become evident only after a product is in use by the general population.
Duodart Side Effect Report#9349560
Hepatic Enzyme Increased, Hepatic Enzyme Increased
This Hepatic Enzyme Increased side effect was reported by a physician from VN. A 67-year-old male patient (weight:NA) experienced the following symptoms/conditions: benign prostatic hyperplasia.The patient was prescribed Duodart (drug dosage: NA), which was initiated on
Jan 22, 2013. Concurrently used drugs: NA..After starting to take Duodart the consumer reported adverse symptoms, such as: Hepatic Enzyme Increased, Hepatic Enzyme IncreasedThese side effects may potentially be related to Duodart.
Duodart Side Effect Report#9340726
Urinary Tract Infection, White Blood Cell Count Increased
This is a report of a 70-year-old male patient (weight: NA) from PL, suffering from the following health symptoms/conditions: exeresis, who was treated with Duodart (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Urinary Tract Infection, White Blood Cell Count Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Duodart treatment in male patients, resulting in Urinary Tract Infection side effect.
Duodart Side Effect Report#9255643
Erythema Multiforme, Rash Pruritic
This report suggests a potential Duodart Erythema Multiforme side effect(s) that can have serious consequences. A 74-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: NA and used Duodart (dosage: NA) starting
Nov 07, 2011. After starting Duodart the patient began experiencing various side effects, including: Erythema Multiforme, Rash PruriticAdditional drugs used concurrently: NA. Although Duodart demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Erythema Multiforme, may still occur.
Duodart Side Effect Report#9186192
Hypersensitivity, Urticaria, Skin Reaction, Bronchospasm, Dyspnoea, Rhinorrhoea
This Hypersensitivity problem was reported by a physician from CL. A 73-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: benign prostatic hyperplasia. On
Mar 07, 2013 this consumer started treatment with Duodart (dosage: 1cap Per Day). The following drugs were being taken at the same time: NA. When using Duodart, the patient experienced the following unwanted symptoms/side effects: Hypersensitivity, Urticaria, Skin Reaction, Bronchospasm, Dyspnoea, RhinorrhoeaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypersensitivity, may become evident only after a product is in use by the general population.
Duodart Side Effect Report#9147387
Melaena, Gastrointestinal Haemorrhage, Hypersensitivity, Rash Pruritic, Dysuria, Oedema Peripheral, Skin Necrosis, Bronchospasm, Face Oedema
This Melaena side effect was reported by a physician from PH. A 67-year-old male patient (weight:NA) experienced the following symptoms/conditions: benign prostatic hyperplasia.The patient was prescribed Duodart (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Prednisone
.After starting to take Duodart the consumer reported adverse symptoms, such as: Melaena, Gastrointestinal Haemorrhage, Hypersensitivity, Rash Pruritic, Dysuria, Oedema Peripheral, Skin Necrosis, Bronchospasm, Face OedemaThese side effects may potentially be related to Duodart. The patient was hospitalized.
Duodart Side Effect Report#9105689
Dizziness, Hypotension, Fall, Head Injury
This is a report of a 56-year-old male patient (weight: NA) from CO, suffering from the following health symptoms/conditions: benign prostatic hyperplasia, who was treated with Duodart (dosage: NA, start time: 201301), combined with: NA. and developed a serious reaction and side effect(s): Dizziness, Hypotension, Fall, Head Injury after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Duodart treatment in male patients, resulting in Dizziness side effect.
Duodart Side Effect Report#9056888
Epilepsy, Dizziness, Hair Colour Changes, Withdrawal Syndrome, Dizziness, Ataxia
This report suggests a potential Duodart Epilepsy side effect(s) that can have serious consequences. A 75-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: benign prostatic hyperplasia and used Duodart (dosage: .9mg In The Morning) starting 2007. After starting Duodart the patient began experiencing various side effects, including: Epilepsy, Dizziness, Hair Colour Changes, Withdrawal Syndrome, Dizziness, AtaxiaAdditional drugs used concurrently:
  • Tamsulosin
The patient was hospitalized. Although Duodart demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Epilepsy, may still occur.
Duodart Side Effect Report#8924324
Bladder Dysfunction, Malaise
This Bladder Dysfunction problem was reported by a physician from RO. A 80-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: adenoma benign. On NS this consumer started treatment with Duodart (dosage: NA). The following drugs were being taken at the same time: NA. When using Duodart, the patient experienced the following unwanted symptoms/side effects: Bladder Dysfunction, MalaiseThe 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 Bladder Dysfunction, may become evident only after a product is in use by the general population.
Duodart Side Effect Report#8848578
Myocardial Ischaemia, Electrocardiogram Qrs Complex Shortened, Malaise, Dizziness, Asthenia, Tachycardia, Supraventricular Tachycardia, Blood Pressure Decreased, Chest Discomfort
This Myocardial Ischaemia side effect was reported by a health professional from ES. A 84-year-old male patient (weight:NA) experienced the following symptoms/conditions: benign prostatic hyperplasia.The patient was prescribed Duodart (drug dosage: NA), which was initiated on 201206. Concurrently used drugs:
  • Renitec
  • Gliclazide
  • Tamsulosin
  • Low Molecular Weight Heparin
  • Eutirox
  • Atorvastatine
.After starting to take Duodart the consumer reported adverse symptoms, such as: Myocardial Ischaemia, Electrocardiogram Qrs Complex Shortened, Malaise, Dizziness, Asthenia, Tachycardia, Supraventricular Tachycardia, Blood Pressure Decreased, Chest DiscomfortThese side effects may potentially be related to Duodart. The patient was hospitalized.
Duodart Side Effect Report#8825193
Pancreatitis Acute
This is a report of a 65-year-old male patient (weight: NA) from ES, suffering from the following health symptoms/conditions: benign prostatic hyperplasia, who was treated with Duodart (dosage: NA, start time:
Sep 03, 2012), combined with: NA. and developed a serious reaction and side effect(s): Pancreatitis Acute after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Duodart treatment in male patients, resulting in Pancreatitis Acute side effect. The patient was hospitalized.
Duodart Side Effect Report#8825191
Tachycardia, Dizziness, Malaise, Nervousness, Atrial Fibrillation
This report suggests a potential Duodart Tachycardia side effect(s) that can have serious consequences. A 83-year-old male patient (weight: NA) from ES was diagnosed with the following symptoms/conditions: benign prostatic hyperplasia,schizophrenia and used Duodart (dosage: NA) starting 2008. After starting Duodart the patient began experiencing various side effects, including: Tachycardia, Dizziness, Malaise, Nervousness, Atrial FibrillationAdditional drugs used concurrently:
  • Haloperidol
  • Akineton
Although Duodart demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Tachycardia, may still occur.
Duodart Side Effect Report#8773567
Hepatic Cirrhosis, Liver Disorder
This Hepatic Cirrhosis problem was reported by a health professional from DE. A 84-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Duodart (dosage: NA). The following drugs were being taken at the same time: NA. When using Duodart, the patient experienced the following unwanted symptoms/side effects: Hepatic Cirrhosis, Liver DisorderAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hepatic Cirrhosis, may become evident only after a product is in use by the general population.
Duodart Side Effect Report#8713426
Abnormal Faeces, Micturition Disorder, Testicular Pain, Cardiovascular Disorder, Urinary Retention, Syncope
This Abnormal Faeces side effect was reported by a physician from DE. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Duodart (drug dosage: NA), which was initiated on 201102. Concurrently used drugs:
  • Anesthetic
  • Analgesic
  • Simvastatin
.After starting to take Duodart the consumer reported adverse symptoms, such as: Abnormal Faeces, Micturition Disorder, Testicular Pain, Cardiovascular Disorder, Urinary Retention, SyncopeThese side effects may potentially be related to Duodart. The patient was hospitalized.
Duodart Side Effect Report#8699731
Urinary Retention, Sepsis
This is a report of a 86-year-old male patient (weight: NA) from DE, suffering from the following health symptoms/conditions: NA, who was treated with Duodart (dosage: NA, start time: 2010), combined with: NA. and developed a serious reaction and side effect(s): Urinary Retention, Sepsis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Duodart treatment in male patients, resulting in Urinary Retention side effect. The patient was hospitalized.


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The appearance of Duodart 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.

What are common Duodart Side Effects for Women?

Women Side Effects Reports

What are common Duodart Side Effects for Men?

Men Side Effects Reports
Dizziness 7
Malaise 6
Dyspnoea 4
Fall 3
Hypersensitivity 3
Myalgia 3
Rash Pruritic 3
Bronchospasm 2
Hepatic Enzyme Increased 2
Hypotension 2

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Why Your Notes are Important

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    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.

    Duodart 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: 34

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    Reported hospitalizations: 10

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