Leuprolide acetate

Side effects and indications

Whenever possible, frequency information about the side effects was extracted from the labels. Aggregated frequency information for the drug and, if available, placebo is shown. To the right, you can click on shaded boxes to be taken to mentions of the side effect on the label. (In some cases, the side effect cannot be highlighted due to conversion problems.) Information about indications was extracted from the indications and usage sections of the labels.

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MedDRA Preferred Term Side effect Data for drug Placebo Labels (show all 17)
1 2 3 4 5 6 7 8 9 10
Hyperhidrosis def Sweating def 57% - 98% 17.8% - 29% x x x x x x x
Hyperhidrosis def postmarketing x
Sweating increased x
Menopausal symptoms def Hot flush def postmarketing, 57% - 98% 17.8% - 29% x x x x x x x x x
Hot flush def Hot flush def postmarketing, 57% - 98% 17.8% - 29% x x x x x x x x x
Headache def Headache def postmarketing, 2.61% - 65% 6% - 17.8% x x x x x x
Migraine def Migraine def 46% - 65% x
Mood swings Mood swings postmarketing, 4.51% - 34% 3% - 4.3% x x x x
Affect lability Mood swings postmarketing, 4.51% - 34% 3% - 4.3% x x x x
Sleep disorder def Sleep disorder def postmarketing, 12.7% - 31.4% x x x
Insomnia def Insomnia def 12.7% - 31.4% x x x x x x
Nausea def Nausea def postmarketing, 12.5% - 29.1% 3% - 3.7% x x x x x x x
Pain def Pain def postmarketing, 2% - 29.1% 0% - 6.13% x x x x x x x x x x
Stinging x x x x
Vomiting def Vomiting def postmarketing, 12.5% - 29.1% 3% - 3.7% x x x x x
Vaginal inflammation def Vaginal inflammation def 2% - 20% 0% - 1.84% x x
Vaginal infection def Vaginal inflammation def 2% - 20% 0% - 1.84% x x
Asthenia def Asthenia def 11% - 18.2% 0% - 4.91% x x x x x
Fatigue def x x x x
Weakness def x x x x x x x
Dizziness def Dizziness def 7% - 16% 0% - 3.7% x x x x x x
Syncope def x x x x x
Lightheadedness x
Vertigo def Vertigo def 7% - 16% x x x
Tenderness def Tenderness def 5.88% - 13% 0% - 4.3% x x x x x
Nervousness def Nervousness def 3.64% - 11% 0% - 0.613% x x x
Tension def Nervousness def 3.64% - 11% 0% - 0.613% x x x
Mucous membrane disorder Mucous membrane disorder 3.92% - 11% x
Alopecia def Alopecia def 0% - 9.09% x x x x x x
Oedema def Oedema def 0% - 9.09% 1.2% - 3.23% x x x x x
Neuromyopathy def Neuromyopathy def 1.96% - 9.09% 0% x x
Injection site reaction def Injection site reaction def postmarketing, 1.96% - 9.09% x x x x
Abscess def Abscess def postmarketing, 5% - 9% x x x x x
Anxiety def Anxiety def 0% - 8.09% x x
Memory impairment def Memory impairment def 1.82% - 6% x x
Menstrual disorder def Menstrual disorder def 0% - 5.15% x
Haemorrhage def Haemorrhage def 2% - 3.09% x x x
Haemoglobin def Haemorrhage def 2% - 3.09% x x x
Seborrhoeic dermatitis def Seborrhoeic dermatitis def 2% - 3.09% x
Vaginal haemorrhage def Bleeding vaginal def 3% - 3.09%
Vaginal discharge def Vaginal discharge def 3% - 3.09%
Acne def Acne def 2% - 3.09% 0% x x
Erythema multiforme def Erythema multiforme def 2% - 3% x
Dermatitis def Rash def postmarketing, 2% - 3% x x x x x
Dermatitis def x
Rash def Rash def postmarketing, 2% - 3% x x x x x
Erythema def Erythema def 2% - 3% x x x x x x x
Vasodilation procedure Vasodilation def 2% - 2.14% x x x
Abdominal pain def Abdominal pain def postmarketing x
Gastrointestinal pain def Abdominal pain def postmarketing x
Adenoma benign def Adenoma benign def postmarketing x x x x x
Asthma def Asthma def postmarketing x x x x
Mental disorder def Mental disorder def postmarketing x x
Mental state abnormal postmarketing x x x x x
Breast disorder def Breast disorder def postmarketing x x
Transient ischaemic attack def Transient ischaemic attack def postmarketing x x
Chest pain def Chest pain def postmarketing x x
Connective tissue disorder def Connective tissue disorder def postmarketing x
Convulsion def Convulsion def postmarketing x x x
Diabetes mellitus def Diabetes mellitus def postmarketing x x x
Dyspnoea def Dyspnoea def postmarketing x x x
Embolism def Embolism def postmarketing x x
Thromboembolism def postmarketing x
Fibromyalgia def Fibromyalgia def postmarketing x x x
Flushing def Flushing def postmarketing x x
Gastrointestinal disorder def Gastrointestinal disorder def postmarketing x
Digestion impaired x
Hypersensitivity def Hypersensitivity def postmarketing x
Hypertension def Hypertension def postmarketing x x x x
Hypotension def Hypotension def postmarketing x x x x x x x
Infarction def Infarction def postmarketing x x x x x
Myocardial infarction def Myocardial infarction def postmarketing x x x
Acute coronary syndrome def Myocardial infarction def postmarketing x x x
Nervous system disorder def Nervous system disorder def postmarketing x
Nodule def Nodule def postmarketing x
IIIrd nerve paralysis def Ophthalmoplegia def postmarketing x x x x x
Ophthalmoplegia def Ophthalmoplegia def postmarketing x x x x x
Neuropathy peripheral def Neuropathy peripheral def postmarketing x x x x x
Neuropathy def postmarketing x x x x x
Pituitary tumour benign def Pituitary adenoma def postmarketing x x x x x
Pituitary haemorrhage Pituitary apoplexy def postmarketing x x x x x
Pulmonary embolism def Pulmonary embolism def postmarketing x x
Respiratory disorder def Respiratory disorder def postmarketing x x
Shock def Shock def postmarketing x x x x x
Syncope def x x x x x
Cerebrovascular accident def Cerebrovascular accident def postmarketing x x x x x
Tenosynovitis def Tenosynovitis def postmarketing x x x x x
Embolism venous Thromboembolism def postmarketing x
Thrombosis def Thrombosis def postmarketing x x
Urticaria def Urticaria def postmarketing x x x x x
Angiopathy def Angiopathy def postmarketing x x
Venous thrombosis def Venous thrombosis def postmarketing x
Weight increased def Weight increased def postmarketing 0% - 1.23% x x x x x x x
Hepatic function abnormal Hepatic function abnormal postmarketing x x
Deep vein thrombosis def Deep vein thrombosis def postmarketing x
Photosensitivity reaction def Photosensitivity reaction def postmarketing x x x x x
Photosensitivity def postmarketing x x x x x
Malaise def Sickness postmarketing x
Malaise def x
Myalgia def Myalgia def postmarketing 0% x x x x x
Tenderness muscle x
Musculoskeletal discomfort Myalgia def postmarketing 0% x x x x x
Arthralgia def x x x x
Prostatic pain def Prostatic pain def postmarketing x x x x x
Hearing impaired def Auditory disorder NOS def postmarketing x
Hearing impaired def x
Induration def Induration def postmarketing x x x x x x x
Pituitary infarction Pituitary infarction postmarketing x x x x x
Suicidal ideation def Suicidal ideation def postmarketing x
Paralysis def Paralysis def postmarketing x x x x x
Abdominal discomfort Distress gastrointestinal postmarketing x x x
Upset stomach x
White blood cell count decreased White blood cell count decreased postmarketing x x x x x x
Bone density decreased Bone density decreased postmarketing x x x x x
Abdominal distension def Abdominal distension def x
Distention def x
Amnesia def Amnesia def
Anaemia def Anaemia def x x x
Aneurysm def Aneurysm def x
Angina pectoris def Angina pectoris def x x
Decreased appetite Anorexia def x x
Decreased appetite x
Anosmia def Anosmia def x
Aortic aneurysm def Aortic aneurysm def x
Arrhythmia def Arrhythmia def x
Arthralgia def Arthralgia def x x x x
Arthritis def Arthritis def x
Back pain def Back pain def x x
Balanitis def Balanitis def x
Blister def Blister def x
Dermatitis bullous def Blister def x
Breast feeding def Breast feeding def x
Bronchitis def Bronchitis def x
Neoplasm malignant def Carcinoma def x
Cardiovascular disorder def Cardiovascular disorder def x
Carotid bruit Carotid bruit x
Cellulitis def Cellulitis def x
Cervix disorder def Cervix disorder def x
Pleuritic pain def Pleuritic pain def x
Colitis def Colitis def x x
Conjunctivitis def Conjunctivitis def x
Constipation def Constipation def x x x
Cough def Cough def x x
Libido decreased def Libido decreased def 0% x x x x x
Disturbance in sexual arousal Libido decreased def 0% x x x x x
Dysphagia def Dysphagia def x x x
Delusion def Delusion def x
Diarrhoea def Diarrhoea def x x
Dysgeusia def Dysgeusia def x
Dysmenorrhoea def Dysmenorrhoea def
Dyspepsia def Dyspepsia def x
Digestion impaired x
Dysuria def Dysuria def x x x x
Ear pain def Ear pain def
Ecchymosis def Ecchymosis def x x x x
Effusion def Effusion def x
Toxic epidermal necrolysis def Toxic epidermal necrolysis def
Epidermodysplasia verruciformis def Epidermodysplasia verruciformis def x
Epistaxis def Epistaxis def x
Eructation def Eructation def x
Fatigue def Fatigue def x x x x
Feminisation acquired def Feminization def
Body temperature increased def Body temperature increased def x x x x
Fibrosis def Fibrosis def x
Fistula def Fistula def x
Flatulence def Flatulence def x x x
Gastroenteritis def Gastroenteritis def x x
Gastrointestinal haemorrhage def Gastrointestinal haemorrhage def x
Gingivitis def Gingivitis def x
Goitre def Goitre def x
Gynaecomastia def Gynaecomastia def x x x x x x
Hair disorder def Hair disorder def x x
Hallucination def Hallucination def x
Cardiac failure def Cardiac failure def x x
Cardiac failure congestive def Cardiac failure congestive def x x
Haematoma def Haematoma def x
Haematuria def Haematuria def x x x x x x x
Blood urine x x
Haemoptysis def Haemoptysis def x x
Hepatitis def Hepatitis def x
Hepatomegaly def Hepatomegaly def x
Hernia def Hernia def x
Inguinal hernia def Inguinal hernia def x
Herpes zoster def Herpes zoster def x
Hirsutism def Hirsutism def 0% - 3.23% x
Hyperglycaemia def Hyperglycaemia def x
Hypertrophy def Hypertrophy def x x x x
Hypoglycaemia def Hypoglycaemia def x
Hypoproteinaemia def Hypoproteinaemia def x
Incontinence def Incontinence def x x x x
Infection def Infection def x x x x
Inflammation def Inflammation def x x
Influenza def Influenza def x x
Irritability def Irritability def x
Ischaemia def Ischaemia def x
Arthropathy def Arthropathy def 0% - 3.1% x
Osteoarthritis def Arthropathy def 0% - 3.1% x
Hyperkeratosis def Keratosis def x
Laryngitis def Laryngitis def
Lethargy def Lethargy def x x x x
Leukopenia def Leukopenia def x
Breast pain def Breast pain def x x
Mediastinal disorder def Mediastinal disorder def x
Menopause def Menopause def x
Muscle spasms def Cramp muscle def x
Muscle spasms def x x x
Muscle atrophy def Muscle atrophy def x x
Myopathy def Myopathy def
Musculoskeletal pain def Musculoskeletal pain def x
Nail disorder def Nail disorder def x
Metastasis def Metastasis def x x x x x x x
Melanocytic naevus def Melanocytic naevus def x
Night sweats def Night sweats def x x x
Hypoaesthesia def Numbness def x
Sensory loss Numbness def x
Nocturia def Nocturia def x x
Obesity def Obesity def x
Obstruction def Obstruction def x x x x x x x
Osteopenia def Osteopenia def x
Pain in extremity def Pain in extremity def x x x x
Pallor def Pallor def x
Palpitations def Palpitations def x x
Paraesthesia def Paraesthesia def 0% - 0.613% x x x x x x x x
Paresthesia lower limb x x x x x x x
Penis disorder def Penis disorder def x x x
Peptic ulcer def Peptic ulcer def x x
Personality disorder def Personality disorder def x x
Pharyngitis def Pharyngitis def
Phlebitis def Phlebitis def x
Pigmentation disorder def Pigmentation def x
Pleural disorder def Pleural disorder def x
Pleural rub Pleural rub x
Pneumonia def Pneumonia def x
Polyp def Polyp def x
Pruritus def Pruritus def x x x x x
Pulmonary oedema def Pulmonary oedema def x
Emphysema def Emphysema def x
Pulmonary fibrosis def Pulmonary fibrosis def x
Purpura def Purpura def
Vascular purpura Purpura def
Pyuria def Pyuria def x
Rales Rales x
Anal fistula Rectal fistula def x
Rectal polyp def Rectal polyp def x
Rhinitis def Rhinitis def x x
Rhonchi def Rhonchi def x
Pharyngitis streptococcal Pharyngitis streptococcal x
Sinusitis def Sinusitis def
Spinal osteoarthritis def Spondylosis def x
Gastric disorder def Gastric disorder def x
Streptococcal infection def Streptococcal infection def x
Swelling def Swelling def x x
Syncope def Syncope def x x x x x
Loss of consciousness def Syncope def x x x x x
Blacked-out (not amnesia) x
Tachycardia def Tachycardia def x x
Testicular disorder def Testicular disorder def x x
Testicular pain def Testicular pain def x x x x
Thirst def Thirst def x
Thyroid neoplasm def Thyroid nodule def x
Tinnitus def Tinnitus def x
Tremor def Tremor def x x
Ulcer def Ulcer def x x x x
Deficiency anaemia Deficiency anaemia
Pollakiuria def Pollakiuria def x x x
Micturition urgency def x x
Urinary incontinence def Urinary incontinence def x
Urinary tract infection def Urinary tract infection def x x
Visual impairment def Visual impairment def
Visual acuity reduced Visual impairment def
Blindness def Visual impairment def
Weight decreased def Weight decreased def
Wheezing def Wheezing def x
Dry mouth def Dry mouth def x x x
Urinary retention def Urinary retention def x x x
Peripheral vascular disorder def Peripheral vascular disorder def
Chills def Chills def x
Rigors x x
Skin odour abnormal Body odor def x x
Micturition urgency def Micturition urgency def x x
Agitation def Agitation def x
Hyperkinesia def
Oedema peripheral def Oedema peripheral def x x x
Injection site abscess Injection site abscess x
Antinuclear antibody positive def Antinuclear antibody positive def
Blood urea increased Blood urea increased x x
Blood creatinine increased Creatinine increased def x x
Swelling face Swelling face x
Red blood cell sedimentation rate increased Red blood cell sedimentation rate increased
Growth retardation def Growth retardation def
High density lipoprotein decreased High density lipoprotein decreased x
Skin hypertrophy Skin hypertrophy
Bone pain def Bone pain def x
Injection site pain Injection site pain x
Hyporeflexia Hyporeflexia x
Hyperreflexia Hyperreflexia x
Dry skin def Dry skin def x
Sinus congestion Sinus congestion x
Skin striae def Skin striae def x
Testicular atrophy Testicular atrophy x x x x
Haemoglobin decreased def Haemoglobin decreased def x
Iron deficiency anaemia def Iron deficiency anaemia def
Leukoderma def Leukoderma def
Prostatic specific antigen decreased Prostatic specific antigen decreased x
Urinary tract obstruction def Urinary tract obstruction def x x x x x x x
Musculoskeletal stiffness Muscle stiffness x
Stiffness x
Blood urine Blood urine x x
Blood urine present Blood urine x x
Discomfort def Malaise def x
Feeling abnormal Malaise def x
Ill-defined disorder Malaise def x
Burning sensation def Burning foot x
Chest discomfort Chest tightness x
Increased appetite Increased appetite
Hallucination, auditory Hallucination, auditory x
Injection site abscess sterile Injection site abscess sterile x
Euphoric mood def Euphoric mood def x
Sputum increased Sputum increased x
Increased bronchial secretion Sputum increased x
Breast enlargement Breast enlargement female x
Breast enlargement x x x
Condition aggravated Condition aggravated x x
Lung infiltration Lung infiltration x
Breath sounds abnormal Respiratory sounds decreased x
Blood oestrogen decreased Oestrogen low x
Iron deficiency Iron deficiency
Blood testosterone decreased Testosterone low x x
Furuncle def Furuncle def x
Erectile dysfunction def Erectile dysfunction def x x x x x x
Breast tenderness Breast tenderness x x x
Blood bilirubin increased def Blood bilirubin increased def x
Atrophy def Atrophy def x x x x x
Extrasystoles def Extrasystoles def x
Pelvic fibrosis Pelvic fibrosis x
Joint effusion def Effusion of knee x
Vision blurred def Vision blurred def x
Cold sweat Sticky skin x x x
Sticky skin Sticky skin x x x
Balance disorder Disequilibrium syndrome x
Crying def Tearfulness x
Tearfulness Tearfulness x
Hyperkinesia def Hyperkinesia def
Bladder pain def Bladder spasm def x x x
Bladder spasm def Bladder spasm def x x x
Red blood cell count decreased Red blood cell count decreased x x
Specific gravity urine increased Specific gravity urine increased x
Bradycardia def Bradycardia def x
Lymphadenopathy def Lymphadenopathy def x
Abscess sterile Abscess sterile x
Injection site haematoma Injection site haematoma x
Face oedema def Face oedema def
Hypercalcaemia def Ca++ increased x
Gait disturbance def Gait disturbance def x
Blood sodium increased Sodium high x
Cardiac murmur def Systolic ejection murmur x
Skin cancer def Skin carcinoma def x
Emotional distress def Emotional distress def x
Aortic dissection def Dissecting aortic aneurysm, thoracic x
Blood uric acid increased Hyperuricaemia def x
Hyperuricaemia def Hyperuricaemia def x
Aortic aneurysm rupture Aortic aneurysm rupture x
Thrombocytosis def Thrombocytosis def x
Local reaction Local reaction x
Blood albumin decreased Albumin low x
Protein total decreased Protein total decreased x
Liver function test abnormal Raised liver function tests x
Prostate cancer metastatic def Prostate cancer metastatic def x x
Penile swelling Penile swelling x
Deafness def Hearing impaired def x
Blood cholesterol increased High cholesterol def x
Somnolence def Somnolence def x
Loss of libido Loss of libido x
Indication Labels
Adverse reaction def x
Anaemia def x
Congenital adrenal hyperplasia def x x
Endometriosis def x
Hyperplasia def x x
Hyperplasia adrenal def x x
Leiomyoma def x
Neoplasm def x x
Neoplasm malignant def x x x x x x
Pain def x
Precocious puberty def x x
Prostate cancer def x x x x x x
Prostatic disorder def x x x x
Puberty def x x
Uterine leiomyoma def x

Information

More information: STITCH, PubChem and possibly Wikipedia or Medpedia

ATC Code: L02AE02

Legend

Color scheme: standard – alternative

100%    
75%    
50%    
10%    
frequent (1% to 100%)    
infrequent (0.1% to 1%)    
rare (<0.1%)    
postmarketing    
0%    
no frequency information    
not found on label    

Labels

Labels were obtained from different sources and potentially contain different sets of side effects. If you click on the label name, a HTML version of the label will be shown with proteins, chemicals and side efffects highlighted using Reflect.

  1. LEUPROLIDE ACETATE / VIADUR : 28 side effects (Drugs@FDA)
  2. Leuprolide Acetate / Eligard : 37 side effects (FDA CDER)
  3. LEUPROLIDE ACETATE / ELIGARD : 38 side effects (Drugs@FDA)
  4. Leuprolide Acetate / Eligard : 39 side effects (FDA CDER)
  5. leuprolide : 56 side effects (FDA XML label)
  6. LEUPROLIDE : 65 side effects (FDA XML label)
  7. LEUPROLIDE ACETATE / ELIGARD 7.5MG : 77 side effects (Health Canada)
  8. LEUPROLIDE : 91 side effects (FDA XML label)
  9. LEUPROLIDE : 95 side effects (FDA XML label)
  10. LEUPROLIDE : 188 side effects (FDA XML label)