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Roflumilast Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 181 

Dyspnoea, Chronic Obstructive Pulmonary Disease (8223905-2)
on Mar 08, 2012 Male from GERMANY , 57 years of age, weighting 160.9 lb, was diagnosed with
  • chronic obstructive pulmonary disease
and was treated with Roflumilast. Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: dyspnoea, chronic obstructive pulmonary disease. Roflumilast dosage: 1 Dosage Forms.
Associated medications used:
  • Nac Diagnostic Reagent
  • Methylprednisolone


Weight Decreased, Atrioventricular Block, Nasopharyngitis, Asthenia, Decreased Appetite (8222908-1)
Patient was taking Roflumilast. Patient felt the following Roflumilast side effects: weight decreased, atrioventricular block, nasopharyngitis, asthenia, decreased appetite on Mar 09, 2012 from GERMANY Additional patient health information: Male , 72 years of age, weighting 147.7 lb, was diagnosed with
  • chronic obstructive pulmonary disease
and. Roflumilast dosage: 500 Mcg. Patient was hospitalized.

Muscular Weakness, Monoplegia, Abasia, Oedema Peripheral, Back Pain (8215071-4)
Adverse event was reported on Mar 06, 2012 by a Female taking Roflumilast (Dosage: 500 Mcg) . Location: GERMANY , weighting 176.4 lb, After Roflumilast was administered, patient encountered several Roflumilast side effects: muscular weakness, monoplegia, abasia, oedema peripheral, back pain.

Subileus (8213242-4)
on Mar 02, 2012 Male from GERMANY , 67 years of age, was diagnosed with
  • chronic obstructive pulmonary disease
and was treated with Roflumilast. Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: subileus. Roflumilast dosage: N/A. Patient was hospitalized.


Anxiety, Tachycardia, Tremor, Overdose, Decreased Appetite (8212030-2)
on Mar 03, 2012 Male from GERMANY , 68 years of age, weighting 176.4 lb, was diagnosed with
  • chronic obstructive pulmonary disease
and was treated with Roflumilast. Patient felt the following Roflumilast side effects: anxiety, tachycardia, tremor, overdose, decreased appetite. Roflumilast dosage: 1000 Mcg.
Multiple prescriptions taken:
  • Inhalators


Breast Swelling, Breast Pain (8206003-3)
Patient was taking Roflumilast. After Roflumilast was administered, patient encountered several Roflumilast side effects: breast swelling, breast pain on Feb 29, 2012 from GERMANY Additional patient health information: Male , 56 years of age, weighting 209.4 lb, . Roflumilast dosage: N/A.
Multiple concurrent drugs taken:
  • Albuterol
  • Simvastatin
  • Buprenorphine
  • Prednisolone
  • Onbrez
  • Acc Long


Deafness Neurosensory (8190429-0)
Adverse event was reported on Feb 24, 2012 by a Male taking Roflumilast (Dosage: 500 Mcg) . Location: GERMANY , weighting 115.7 lb, Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: deafness neurosensory.

Asthenia (8181440-4)
on Feb 24, 2012 Male from GERMANY , 84 years of age, was treated with Roflumilast. Patient felt the following Roflumilast side effects: asthenia. Roflumilast dosage: N/A.
Multiple prescriptions taken:
  • Atenolol (0.5 Df)
  • Omeprazole
  • Nitroglycerin (15 Mg)


Atrioventricular Block, Decreased Appetite, Weight Decreased (8181373-3)
on Feb 20, 2012 Male from GERMANY , 70 years of age, was diagnosed with
  • chronic obstructive pulmonary disease
and was treated with Roflumilast. After Roflumilast was administered, patient encountered several Roflumilast side effects: atrioventricular block, decreased appetite, weight decreased. Roflumilast dosage: 500 Mcg.

Epistaxis (8179100-9)
Patient was taking Roflumilast (roflumilast) (tablets). Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: epistaxis on Feb 22, 2012 from GERMANY Additional patient health information: Male , 49 years of age, was diagnosed with
  • chronic obstructive pulmonary disease
and. Roflumilast (roflumilast) (tablets) dosage: (1 In 1 D).
Associated medications used:
  • Serevent (salmeterol Xinafoate) (salmeterol Xinafoate)
  • Spiriva (tiotropium Bromide) (tiotropium Bromide)
  • Berodual (fenoterol, Ipratropium) (fenoterol, Ipratropium)


Suicide Attempt, Abdominal Pain, Tachycardia, Intentional Overdose (8178491-2)
Adverse event was reported on Feb 20, 2012 by a Male taking Roflumilast (Dosage: N/A) was diagnosed with
  • chronic obstructive pulmonary disease
and. Location: GERMANY , weighting 110.2 lb, Patient felt the following Roflumilast side effects: suicide attempt, abdominal pain, tachycardia, intentional overdose.
Multiple prescriptions taken:
  • Beta Blocker
  • Aspirin
  • Ace Inhibitor
  • Verapamil (160 Mg)
  • Ramipril
  • Fluticasone Propionate/salmeterol (1 Dosage Form (1 Puff, 50/ 250))
  • Spiriva (1 Dosage Form (1 Puff))


Chronic Obstructive Pulmonary Disease, Cachexia, Condition Aggravated, Respiratory Failure (8152020-1)
on Feb 02, 2012 Male from GERMANY , 66 years of age, weighting 105.8 lb, was diagnosed with
  • chronic obstructive pulmonary disease
and was treated with Roflumilast (roflumilast) (tablets). After Roflumilast was administered, patient encountered several Roflumilast side effects: chronic obstructive pulmonary disease, cachexia, condition aggravated, respiratory failure. Roflumilast (roflumilast) (tablets) dosage: 500 Mcg (500 Mcg,1 In 1 D),oral.
Multiple concurrent drugs taken:
  • Oxygen (oxygen)(oxygen)
  • Calcivit (cevicalcit) (cevicalcit)
  • Albuterol
  • Nebilet (nebivolol Hydrochloride) (nebivolol Hydrochloride)
  • Symbicort(budesonide W/formoterol Fumarate)(budesonide W/formoterol Fu
  • Amlodipine
  • Spiriva(tiotropium Bromide)(tiotropium Bromide)
  • Theophylline


Diarrhoea, Headache, Decreased Appetite, Nausea, Dehydration, Palpitations, Toxicity To Various Agents (8134421-0)
on Jan 26, 2012 Female from GERMANY , 81 years of age, weighting 143.3 lb, was diagnosed with
  • chronic obstructive pulmonary disease
and was treated with Roflumilast (roflumilast) (500 Microgram, Tablets). Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: diarrhoea, headache, decreased appetite, nausea, dehydration, palpitations, toxicity to various agents. Roflumilast (roflumilast) (500 Microgram, Tablets) dosage: 500 Mcg (500 Mcg, 1 In 1 D), Oral 250 Mcg (250 Mcg, 1 In 1 D), Oral. Patient was hospitalized.

Muscle Spasms, Sleep Disorder, Headache, Hyperhidrosis, Dizziness, Blood Cholesterol Increased (8132821-6)
Patient was taking Roflumilast (roflumilast) (tablets). Patient felt the following Roflumilast side effects: muscle spasms, sleep disorder, headache, hyperhidrosis, dizziness, blood cholesterol increased on Jan 27, 2012 from GERMANY Additional patient health information: Male , 60 years of age, weighting 253.5 lb, was diagnosed with
  • chronic obstructive pulmonary disease
and. Roflumilast (roflumilast) (tablets) dosage: 500 Mcg, Oral.
Multiple prescriptions taken:
  • Diltiagamma (diltiazem Hydrochloride)
  • Blopress 32 Pluss (candesartan)
  • Hirobriz
  • Budesonide
  • Spiriva
Patient was hospitalized.

Gastrointestinal Haemorrhage (8118589-8)
Adverse event was reported on Jan 20, 2012 by a Female taking Roflumilast (roflumilast) (tablets) (Dosage: 500 Mcg (500 Mcg,1 In 1 D),oral) was diagnosed with
  • chronic obstructive pulmonary disease
and. Location: GERMANY , 76 years of age, weighting 224.9 lb, After Roflumilast was administered, patient encountered several Roflumilast side effects: gastrointestinal haemorrhage.

Bladder Cancer (8118246-8)
on Jan 25, 2012 Male from GERMANY , 74 years of age, weighting 176.4 lb, was diagnosed with
  • chronic obstructive pulmonary disease
and was treated with Roflumilast (roflumilast) (500 Microgram, Tablets). Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: bladder cancer. Roflumilast (roflumilast) (500 Microgram, Tablets) dosage: 500 Mcg (500 Mcg, 1 In 1 D), Oral.

Condition Aggravated, Respiratory Failure, Chronic Obstructive Pulmonary Disease (8113096-0)
on Jan 18, 2012 Male from GERMANY , 66 years of age, weighting 105.8 lb, was diagnosed with
  • chronic obstructive pulmonary disease
and was treated with Roflumilast (roflumilast) (tablets). Patient felt the following Roflumilast side effects: condition aggravated, respiratory failure, chronic obstructive pulmonary disease. Roflumilast (roflumilast) (tablets) dosage: 500 Mcg (500 Mcg, 1 In 1 D) Oral.

Back Pain, Myalgia, Depression, Suicidal Ideation, Asthenia (8099156-1)
Patient was taking Roflumilast (roflumilast) (500 Microgram, Tablets). After Roflumilast was administered, patient encountered several Roflumilast side effects: back pain, myalgia, depression, suicidal ideation, asthenia on Jan 13, 2012 from GERMANY Additional patient health information: Male , 55 years of age, was diagnosed with
  • chronic obstructive pulmonary disease
and. Roflumilast (roflumilast) (500 Microgram, Tablets) dosage: 500 Mcg (500 Mcg, 1 In 1 D), Oral.
Multiple concurrent drugs taken:
  • Prednisolone
  • Oxygen (oxygen) (oxygen)


Nervousness, Depression, Restlessness, Stress, Anxiety, Condition Aggravated (8078613-8)
Adverse event was reported on Jan 09, 2012 by a Male taking Roflumilast (roflumilast) (tablets) (Dosage: 500 Mcg, Oral) was diagnosed with
  • chronic obstructive pulmonary disease
and. Location: GERMANY , 58 years of age, weighting 185.2 lb, Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: nervousness, depression, restlessness, stress, anxiety, condition aggravated.
Associated medications used:
  • Ibuprofen (ibuprofen) (tablets) (ibuprofen)
  • Symbicort (budesonide W/formoterol Fumarate) (budesonide W/formoterol
  • Albuterol
  • Spiriva (tiotropium Bromide) (tiotropium Bromide)
  • Lisinopril Comp (zestoretic) (zestoretic)


Gastrointestinal Disorder, Rectal Haemorrhage, Weight Decreased (8078322-5)
on Jan 11, 2012 Male from GERMANY , 74 years of age, was diagnosed with
  • chronic obstructive pulmonary disease
and was treated with Roflumilast (roflumilast) (500 Microgram, Tablets). Patient felt the following Roflumilast side effects: gastrointestinal disorder, rectal haemorrhage, weight decreased. Roflumilast (roflumilast) (500 Microgram, Tablets) dosage: 500 Mcg (500 Mcg, 1 In 1 D), Oral.

Abdominal Pain Upper, Gastrointestinal Disorder, Dizziness, Nausea (8068936-0)
on Jan 05, 2012 Male from GERMANY , 62 years of age, weighting 169.8 lb, was diagnosed with
  • chronic obstructive pulmonary disease
and was treated with Roflumilast (roflumilast) (tablets). After Roflumilast was administered, patient encountered several Roflumilast side effects: abdominal pain upper, gastrointestinal disorder, dizziness, nausea. Roflumilast (roflumilast) (tablets) dosage: 500 Mcg (500 Mcg,1 In 1 D),oral.

Pulmonary Hypertension, Cardiopulmonary Failure, Pulmonary Arterial Pressure Increased, Atrial Fibrillation, Right Ventricular Failure, Renal Failure Chronic, Gastritis Erosive, Tricuspid Valve Incompetence (8051880-2)
Patient was taking Roflumilast (roflumilast) (tablets). Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: pulmonary hypertension, cardiopulmonary failure, pulmonary arterial pressure increased, atrial fibrillation, right ventricular failure, renal failure chronic, gastritis erosive, tricuspid valve incompetence on Jan 05, 2012 from GERMANY Additional patient health information: Male , 89 years of age, weighting 158.7 lb, was diagnosed with
  • chronic obstructive pulmonary disease
and. Roflumilast (roflumilast) (tablets) dosage: 500 Mcg (500 Mcg), Oral.
Associated medications used:
  • Delix (ramipril) (2.5 Milligram) (ramipril)
  • Viani Forte (fluticasone, Salmeterol) (fluticasone, Salmeterol)
  • Albuterol
Patient was hospitalized.

Chronic Obstructive Pulmonary Disease, Condition Aggravated (8037551-7)
Adverse event was reported on Dec 27, 2011 by a Male taking Roflumilast (roflumilast) (tablets) (Dosage: Oral) was diagnosed with
  • chronic obstructive pulmonary disease
and. Location: GERMANY , 80 years of age, Patient felt the following Roflumilast side effects: chronic obstructive pulmonary disease, condition aggravated.
Multiple prescriptions taken:
  • Spiriva (tiotropium Bromide) (tiotropium Bromide)
  • Oxygen (oxygen) (oxygen)
  • Foraseq (budesonide, Formoterol Fumarate) (budesonide, Formoterol Fuma
Patient was hospitalized.

Blood Pressure Fluctuation, Cardiovascular Insufficiency, Hypotension, Dizziness, Headache, Chest Pain (8027718-6)
on Dec 22, 2011 Female from GERMANY , 56 years of age, weighting 169.8 lb, was diagnosed with
  • chronic obstructive pulmonary disease
and was treated with Roflumilast (roflumilast) (tablets). After Roflumilast was administered, patient encountered several Roflumilast side effects: blood pressure fluctuation, cardiovascular insufficiency, hypotension, dizziness, headache, chest pain. Roflumilast (roflumilast) (tablets) dosage: (500 Mcg), Oral.
Multiple concurrent drugs taken:
  • Ramipril
  • Metoprolol Succinate


Myocardial Infarction, Electrocardiogram St-t Change, Condition Aggravated, Restlessness, Cardiac Failure, Tachycardia (8027691-0)
on Dec 20, 2011 Female from GERMANY , 46 years of age, was diagnosed with
  • chronic obstructive pulmonary disease
and was treated with Roflumilast (roflumilast) (tablets). Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: myocardial infarction, electrocardiogram st-t change, condition aggravated, restlessness, cardiac failure, tachycardia. Roflumilast (roflumilast) (tablets) dosage: 500 Mcg (500 Mcg, 1 In 1 D), Oral.
Associated medications used:
  • Furix (furosemide) (furosemide)
  • Ventolin (salbutamol) (salbutamol)
  • Symbicort (budesonide, /formoterol Fumarate) (budesonide, /formoterol
  • Spiriva (tiotropium Bromide) (tiotropium Bromide)
  • Mycostatin (nystatin) (nystatin)
  • Bronkyl (acetylcysteine) (acetylcysteine)
  • Atacand
  • Albyl-e (albyl-enterosolubile) (albyl-enterosolubile)
Patient was hospitalized.

Showing 1-25 of 181 

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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Roflumilast Information

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Side Effects reported to FDA: 181. View Roflumilast Adverse Reports

Roflumilast safety alerts: No

Reported deaths: 14

Reported hospitalizations: 25

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