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ATC Code: R03DX07

Side effects

Options: Hide MedDRA Preferred Terms

MedDRA Preferred Term Side effect Data for drug Placebo Labels
1 2
Diarrhoea Diarrhoea 2.4% - 9.46% 2.7% x x
Weight decreased Weight decreased 3.4% - 7.46% 2.12% x x
Back pain Back pain 3.2% 2.19% x x
Nausea Nausea 1.6% - 4.71% 1.43% x x
Influenza Influenza 2.79% 2.67% x
Insomnia Insomnia 2.37% 0.978% x x
Dizziness Dizziness 2.07% 1.07% x x
Decreased appetite Decreased appetite 2.05% 0.358% x x
Abdominal pain Abdominal pain 1.9% x x
Gastrointestinal pain Abdominal pain 1.9% x x
Headache Headache 1.7% - 4.39% 2.08% x x
Angioedema Angioedema postmarketing x x
Dermatitis Rash postmarketing x x
Rash Rash postmarketing x x
Hypersensitivity Hypersensitivity postmarketing x x
Urticaria Urticaria postmarketing x x
Pancreatitis acute Pancreatitis acute x
Anxiety Anxiety x x
Asthenia Asthenia x
Fatigue x
Atrial fibrillation Atrial fibrillation x
Mental disorder Mental disorder x x
Infection Infection x
Connective tissue disorder Connective tissue disorder x x
Constipation Constipation x
Depression Depression x
Dysgeusia Dysgeusia x
Dyspepsia Dyspepsia x x
Endocrine disorder Endocrine disorder x
Fatigue Fatigue x
Gastritis Gastritis x x
Gastrooesophageal reflux disease Gastrooesophageal reflux disease x
Gastrointestinal disorder Gastrointestinal disorder x x
Gynaecomastia Gynaecomastia x
Cardiac disorder Cardiac disorder x
Haematochezia Haematochezia x
Immune system disorder Immune system disorder x
Renal failure acute Renal failure acute x
Mediastinal disorder Mediastinal disorder x
Nervous system disorder Nervous system disorder x x
Nervousness Nervousness x
Tension Nervousness x
Palpitations Palpitations x
Pneumonia Pneumonia x
Respiratory tract infection Respiratory tract infection x
Rhinitis Rhinitis x
Sinusitis Sinusitis x
Muscle spasms Muscle spasms x x
Tremor Tremor x x
Urinary tract infection Urinary tract infection x
Vertigo Vertigo x
Vomiting Vomiting x x
Gamma-glutamyltransferase increased Gamma-glutamyltransferase increased x
Malnutrition Malnutrition x
Skin disorder Unspecified disorder of skin and subcutaneous tissue x
Malaise Malaise x
Discomfort Malaise x
Feeling abnormal Malaise x
Ill-defined disorder Malaise x
Myalgia Myalgia x
Musculoskeletal discomfort Myalgia x
Hepatobiliary disease Hepatobiliary disease x
Prostate cancer Prostate cancer x
Suicidal ideation Suicidal ideation x
Lung neoplasm malignant Carcinoma of lung x
Infestation Infestation NOS x
Completed suicide Completed suicide x


Information about indications was extracted from the indications and usage sections of the labels.


Side effects:34
Source:FDA Structured Product Label

roflumilast / roflumilast

Side effects:48

Color scheme:


    frequent (1% to 100%)
    infrequent (0.1% to 1%)
    rare (<0.1%)
    no frequency information
    not found on label