Dutasteride side effects - from FDA reports


In this review, we analyze Dutasteride side effects by the time on the drug, gender and age of the people who have side effects while taking Dutasteride. The review is based on 2,484 people who have side effects while taking the drug from FDA, and is updated regularly.

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Dutasteride

Dutasteride has active ingredients of dutasteride. It is often used in prostate examination abnormal. (latest outcomes from Dutasteride 2,527 users)


On Mar, 01, 2019

2,484 people who take Dutasteride are studied.


Number of reports submitted per year:

Dutasteride side effects.

Most common side effects over time *:

< 1 month:
  • Coagulopathy (blood's ability to clot is impaired)
  • Dyspnoea (difficult or laboured respiration)
  • Aspartate aminotransferase increased
  • Pulmonary oedema (fluid accumulation in the lungs)
  • Blood pressure increased
  • Renal impairment (severely reduced kidney function)
  • Confusional state
  • Deep vein thrombosis (blood clot in a major vein that usually develops in the legs and/or pelvis)
  • Febrile neutropenia (fever with reduced white blood cells)
  • Oedema peripheral (superficial swelling)
1 - 6 months:
  • Eyelid oedema (eyelids are swollen and contain excessive fluid)
  • Hepatic function abnormal
  • Drug-induced liver injury (diseases of the liver that are caused by physician-prescribed medications)
  • Muscular weakness (muscle weakness)
  • Myalgia (muscle pain)
  • Angina unstable (chest pain due to ischemia of the heart muscle- unstable)
  • Arthropathy
  • Aspartate aminotransferase increased
  • Blood creatine phosphokinase increased
  • Cell marker increased
6 - 12 months:
  • Platelet count decreased
  • Heart rate increased
  • Palmar-plantar erythrodysaesthesia syndrome (hand-foot syndrome)
  • Aspartate aminotransferase increased
  • Blood alkaline phosphatase increased
  • Blood lactate dehydrogenase increased
  • Blood pressure increased
  • Breast haemorrhage (bleeding in breast)
  • Faeces discoloured
  • Gynaecomastia (enlargement of the gland tissue of the male breast)
1 - 2 years:
  • Hepatic function abnormal
  • Visual acuity reduced (reduced clearness of vision)
  • Blood lactate dehydrogenase increased
  • Diarrhoea
  • Vertigo
  • Alanine aminotransferase increased
  • Anal fistula
  • Atrial fibrillation (fibrillation of the muscles of the atria of the heart)
  • Colitis microscopic (inflammation of colon with diarrhoea and abdominal cramps)
  • Dark circles under eyes
2 - 5 years:
  • Haemorrhage (bleeding)
  • Abdominal discomfort
  • Arrhythmia (irregular heartbeat)
  • Chest pain
  • Coronary arterial stent insertion
  • Coronary artery stenosis (narrowing of coronary artery)
  • General physical health deterioration (weak health status)
  • Intervertebral disc disorder (spinal disc disorder)
  • Metastases to kidney (cancer spreads to kidney)
  • Prostatic mass
5 - 10 years:
  • Neuropathy peripheral (surface nerve damage)
  • Pneumonia
  • Prostate cancer
  • Sex hormone binding globulin increased
  • Shock (a life-threatening condition with symptoms like low blood pressure, weakness, shallow breathing, cold, clammy skin)
10+ years:
  • Hypoglycaemia (deficiency of glucose in the bloodstream)
  • Hypotension (abnormally low blood pressure)
not specified:
  • Death
  • Syncope (loss of consciousness with an inability to maintain postural tone)
  • Vomiting
  • Weight decreased
  • Urinary retention (the inability to completely or partially empty the bladder)
  • Electrocardiogram qt prolonged
  • Malaise (a feeling of general discomfort or uneasiness)
  • Pneumonia
  • Pyrexia (fever)
  • Drug ineffective

Most common side effects by gender *:

female:
  • Electrocardiogram qt prolonged
  • Hair growth abnormal
  • Weight increased
  • Abdominal discomfort
  • Arrhythmia (irregular heartbeat)
  • Chest pain
  • Drug ineffective
  • Hypotension (abnormally low blood pressure)
  • Intestinal obstruction
  • Major depression (a mood state that goes well beyond temporarily feeling sad or blue. it is a serious medical illness that affects one's thoughts, feelings)
male:
  • Death
  • Vomiting
  • Urinary tract infection
  • Sopor (sleep)
  • Drug ineffective
  • Dyspnoea (difficult or laboured respiration)
  • Fatigue (feeling of tiredness)
  • Weight increased
  • Myocardial infarction (destruction of heart tissue resulting from obstruction of the blood supply to the heart muscle)
  • Diarrhoea

Most common side effects by age *:

0-1:
  • Red blood cell count decreased
  • Suicidal ideation
2-9:

n/a

10-19:

n/a

20-29:
  • Therapeutic response unexpected
  • Abdominal discomfort
  • Skin reaction
  • Suicide attempt
30-39:
  • Palpitations (feelings or sensations that your heart is pounding or racing)
  • Alopecia effluvium (hair loss and scalp disorder characterized by the thinning or shedding of hair)
  • Hypoglycaemia (deficiency of glucose in the bloodstream)
  • Injection site induration
  • Nausea (feeling of having an urge to vomit)
  • Neuropathy peripheral (surface nerve damage)
  • Orgasm abnormal (abnormal sex satisfaction)
  • Quality of life decreased
40-49:
  • Rhinorrhoea (watery mucus discharge from the nose)
  • Dark circles under eyes
  • Lymphoma (cancer that begins in immune system cells)
  • Anaemia (lack of blood)
  • Aspartate aminotransferase increased
  • Dengue fever
  • Drug ineffective
  • Feeling hot
  • Hepatitis (inflammation of the liver)
  • Pain
50-59:
  • Pulmonary embolism (blockage of the main artery of the lung)
  • Transaminases increased
  • Vomiting
  • Coronary artery disease (plaque building up along the inner walls of the arteries of the heart, which narrows the arteries and restricts blood flow to the heart)
  • Drug ineffective
  • Nausea (feeling of having an urge to vomit)
  • Renal mass (mass in kidney)
  • Thermal burn (burn by heat)
  • Vision blurred
  • Fatigue (feeling of tiredness)
60+:
  • Vomiting
  • Syncope (loss of consciousness with an inability to maintain postural tone)
  • Death
  • Electrocardiogram qt prolonged
  • Weight decreased
  • Urinary retention (the inability to completely or partially empty the bladder)
  • Pneumonia
  • Hepatic function abnormal
  • Urinary tract infection
  • Sopor (sleep)

* Approximation only. Some reports may have incomplete information.

FDA reports used in this study

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On eHealthMe, Dutasteride (dutasteride) is often used to treat enlarged prostate. Find out below the conditions the drugs are used for and how effective they are.

What is the drug used for and how effecitve is it:


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NOTE: The study is based on active ingredients and brand name. Other drugs that have the same active ingredients (e.g. generic drugs) are NOT considered.

WARNING: Please DO NOT STOP MEDICATIONS without first consulting a physician since doing so could be hazardous to your health.

DISCLAIMER: All material available on eHealthMe.com is for informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment provided by a qualified healthcare provider. All information is observation-only, and has not been supported by scientific studies or clinical trials unless otherwise stated. Different individuals may respond to medication in different ways. Every effort has been made to ensure that all information is accurate, up-to-date, and complete, but no guarantee is made to that effect. The use of the eHealthMe site and its content is at your own risk.

You may report adverse side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

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