PatientsVille.com Logo

PatientsVille

Roflumilast Side Effects

Common Roflumilast Side Effects

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

Diarrhoea (63)
Dyspnoea (52)
Weight Decreased (51)
Nausea (50)
Decreased Appetite (40)
Chronic Obstructive Pulmonary Disease (36)
Pneumonia (33)
Dizziness (28)
Condition Aggravated (26)
Headache (26)
Insomnia (26)
Asthenia (24)
Tremor (23)
Malaise (21)
Anxiety (18)
Off Label Use (18)
Death (18)
Depression (16)
Myalgia (15)
Abdominal Pain (15)

➢ 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.

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.

Roflumilast Side Effects Reported to FDA

The following Roflumilast 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.


The appearance of Roflumilast 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.
Pyrexia
on Mar 11, 2014 Male from COUNTRY NOT SPECIFIED , 77 years of age, weighting 141.1 lb, was diagnosed with and was treated with Roflumilast. Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: pyrexia. Roflumilast dosage: 500 Mcg. Patient was hospitalized.

Chronic Obstructive Pulmonary Disease, Nasopharyngitis, Headache, Insomnia, Muscle Strain, Off Label Use
Patient was taking Roflumilast. Patient felt the following Roflumilast side effects: chronic obstructive pulmonary disease, nasopharyngitis, headache, insomnia, muscle strain, off label use on Mar 10, 2014 from US Additional patient health information: Male , 55 years of age, weighting 191.8 lb, was diagnosed with and. Roflumilast dosage: 250 Mcg. Patient was hospitalized.

Breast Cancer
Adverse event was reported on Mar 07, 2014 by a Male taking Roflumilast (Dosage: N/A) . Location: US , 81 years of age, After Roflumilast was administered, patient encountered several Roflumilast side effects: breast cancer.

Fall, Nasopharyngitis
on Mar 07, 2014 Female from US , 61 years of age, weighting 163.1 lb, was diagnosed with and was treated with Roflumilast. Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: fall, nasopharyngitis. Roflumilast dosage: 500 Mcg.
Associated medications used:
  • Formodual
  • Ventolin
  • Atrovent
  • Flumil Forte
Patient was hospitalized.


Pyrexia, Malaise, Tremor, Nasal Congestion, Cough
on Mar 07, 2014 Male from US , 83 years of age, was diagnosed with and was treated with Roflumilast. Patient felt the following Roflumilast side effects: pyrexia, malaise, tremor, nasal congestion, cough. Roflumilast dosage: 500 Mcg. Patient was hospitalized.

Apnoea, Heart Rate Increased, Hypertension
Patient was taking Roflumilast. After Roflumilast was administered, patient encountered several Roflumilast side effects: apnoea, heart rate increased, hypertension on Mar 07, 2014 from US Additional patient health information: Male , 74 years of age, weighting 130.1 lb, was diagnosed with and. Roflumilast dosage: 500 Mcg. Patient was hospitalized.

Tremor
Adverse event was reported on Mar 06, 2014 by a Male taking Roflumilast (Dosage: N/A) was diagnosed with and. Location: US , 70 years of age, weighting 245.6 lb, Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: tremor.

Renal Failure Acute, Asthenia, Fatigue, Malaise, Decreased Appetite, Hypophagia, Atrial Fibrillation, Haemodynamic Instability, Blood Pressure Decreased
on Mar 06, 2014 Male from US , 80 years of age, weighting 130.0 lb, was diagnosed with and was treated with Roflumilast. Patient felt the following Roflumilast side effects: renal failure acute, asthenia, fatigue, malaise, decreased appetite, hypophagia, atrial fibrillation, haemodynamic instability, blood pressure decreased. Roflumilast dosage: N/A.

Hypertensive Crisis
on Mar 06, 2014 Female from US , 62 years of age, weighting 147.7 lb, was diagnosed with and was treated with Roflumilast. After Roflumilast was administered, patient encountered several Roflumilast side effects: hypertensive crisis. Roflumilast dosage: 500 Mcg. Patient was hospitalized.

Renal Failure Acute, Hypotension, Atrial Fibrillation, Haemodynamic Instability
Patient was taking Roflumilast. Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: renal failure acute, hypotension, atrial fibrillation, haemodynamic instability on Mar 05, 2014 from US Additional patient health information: Male , 80 years of age, weighting 137.3 lb, was diagnosed with and. Roflumilast dosage: N/A.
Associated medications used:
  • Normal Saline
  • Amiodarone Drip


Renal Failure Acute
Adverse event was reported on Mar 04, 2014 by a Male taking Roflumilast (Dosage: N/A) was diagnosed with and. Location: US , 80 years of age, weighting 137.0 lb, Patient felt the following Roflumilast side effects: renal failure acute.
Multiple prescriptions taken:
  • Normal Saline
Patient was hospitalized.

Atrial Fibrillation, Dyspnoea, Magnesium Deficiency
on Mar 14, 2014 Male from US , 74 years of age, weighting 180.8 lb, was diagnosed with and was treated with Roflumilast. After Roflumilast was administered, patient encountered several Roflumilast side effects: atrial fibrillation, dyspnoea, magnesium deficiency. Roflumilast dosage: 500 Mcg.
Multiple concurrent drugs taken:
  • Ultibro
Patient was hospitalized.

Faeces Hard, Frequent Bowel Movements
on Mar 13, 2014 Female from US , 75 years of age, weighting 136.7 lb, was diagnosed with and was treated with Roflumilast. Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: faeces hard, frequent bowel movements. Roflumilast dosage: N/A.
Associated medications used:
  • Terbasmin


Renal Surgery, Inflammation, Food Aversion, Diarrhoea
Patient was taking Roflumilast. Patient felt the following Roflumilast side effects: renal surgery, inflammation, food aversion, diarrhoea on Feb 28, 2014 from US Additional patient health information: Male , 77 years of age, weighting 187.4 lb, was diagnosed with and. Roflumilast dosage: 500 Mcg. Patient was hospitalized.

Blood Disorder, Acute Myocardial Infarction, Weight Decreased, Frequent Bowel Movements, Diarrhoea, Off Label Use
Adverse event was reported on Mar 18, 2014 by a Male taking Roflumilast (Dosage: 500 Mcg) was diagnosed with and. Location: US , 59 years of age, weighting 194.0 lb, After Roflumilast was administered, patient encountered several Roflumilast side effects: blood disorder, acute myocardial infarction, weight decreased, frequent bowel movements, diarrhoea, off label use. Patient was hospitalized.

Peptic Ulcer, Chronic Obstructive Pulmonary Disease
on Mar 13, 2014 Male from COUNTRY NOT SPECIFIED , 77 years of age, weighting 165.3 lb, was diagnosed with and was treated with Roflumilast. Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: peptic ulcer, chronic obstructive pulmonary disease. Roflumilast dosage: 500 Mcg.
Associated medications used:
  • Spiriva
  • Seretide 500 Discus
  • Erdos
  • Hebron-f
  • Flomox
  • Solondo
  • Aspirin
  • Depas
Patient was hospitalized.

Cataract Operation, Joint Swelling, Pulmonary Congestion
on Feb 25, 2014 Male from US , 62 years of age, was treated with Roflumilast. Patient felt the following Roflumilast side effects: cataract operation, joint swelling, pulmonary congestion. Roflumilast dosage: 500 Mcg. Patient was hospitalized.

Haemoptysis
Patient was taking Roflumilast. After Roflumilast was administered, patient encountered several Roflumilast side effects: haemoptysis on Mar 10, 2014 from COUNTRY NOT SPECIFIED Additional patient health information: Male , 69 years of age, weighting 152.1 lb, was diagnosed with and. Roflumilast dosage: 500 Mcg.
Multiple concurrent drugs taken:
  • Symbicort Turbuhaler
  • Spiriva Respimat
  • Hebron-f Tab
  • Azeptin Tab
  • Cough Syrup
  • Almagel Tab
Patient was hospitalized.

Colon Neoplasm
Adverse event was reported on Feb 13, 2014 by a Male taking Roflumilast (Dosage: 500 Mcg) was diagnosed with and. Location: US , 78 years of age, Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: colon neoplasm.
Associated medications used:
  • Salbutamol Aldo Union (100 Mcg)
  • Atrovent (20 Mcg)
  • Atorvastatina Normon (10 Mg)
  • Alopurinol Normon (100 Mg)


Pneumonia, Weight Decreased
on Feb 13, 2014 Male from US , 70 years of age, weighting 187.4 lb, was diagnosed with and was treated with Roflumilast. Patient felt the following Roflumilast side effects: pneumonia, weight decreased. Roflumilast dosage: 500 Mcg.
Multiple prescriptions taken:
  • Foster
  • Ventolin
Patient was hospitalized.

Asthenia
on Feb 19, 2014 Female from US , 53 years of age, was diagnosed with and was treated with Roflumilast. After Roflumilast was administered, patient encountered several Roflumilast side effects: asthenia. Roflumilast dosage: 250 Mcg.

Respiratory Tract Congestion
Patient was taking Roflumilast. Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: respiratory tract congestion on Mar 07, 2014 from US Additional patient health information: Male , 83 years of age, . Roflumilast dosage: 500 Mcg. Patient was hospitalized.

Pneumonia, Dyspnoea, Chronic Obstructive Pulmonary Disease
Adverse event was reported on Feb 14, 2014 by a Male taking Roflumilast (Dosage: 500 Mcg) was diagnosed with and. Location: COUNTRY NOT SPECIFIED , 69 years of age, weighting 110.2 lb, Patient felt the following Roflumilast side effects: pneumonia, dyspnoea, chronic obstructive pulmonary disease.
Multiple prescriptions taken:
  • Seretide
  • Spiriva Handihaler
  • Aventro (2500 Mg)
  • Ventolin Nebules
  • Nisolone
  • Megace
  • Pantoloc
  • Wafarin
Patient was hospitalized.

Abdominal Pain Upper, Dry Skin, Muscle Spasms, Investigation
on Jan 31, 2014 Female from US , 47 years of age, was diagnosed with and was treated with Roflumilast. After Roflumilast was administered, patient encountered several Roflumilast side effects: abdominal pain upper, dry skin, muscle spasms, investigation. Roflumilast dosage: N/A.
Multiple concurrent drugs taken:
  • Combivent
  • Onbrize
Patient was hospitalized.


on Jan 31, 2014 Male from US , 76 years of age, was diagnosed with and was treated with Roflumilast. . Roflumilast dosage: N/A. Patient was hospitalized.

1 of 17 



Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


    Track Online

  • User Sign In
  • Register to track your side effects

  • 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.

    Discuss Roflumilast Side Effects



    Did You Have a Roflumilast Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Roflumilast for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Safety Alerts, Active Ingredients, Usage Information

    More About Roflumilast

    Side Effects reported to FDA: 418

    Roflumilast safety alerts: No

    Reported deaths: 41

    Reported hospitalizations: 155

    Latest Roflumilast clinical trials

    Roflumilast Reviews

    No reviews, be a first to report a side effect via side effect reporting form