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Roflumilast Side Effects

Report Roflumilast Side Effects

If you experienced any harmful or unwanted effects of Roflumilast, please share your experience. This could help to raise awareness about Roflumilast side effects, identify uknown risks and inform health professionals and patients taking Roflumilast.

Examples: headache, dizziness


The most commonly reported Roflumilast side effects are:
Low GFR Rate (1 reports)

If you have experienced a side effect listed above, you can check a box to report it.


View a complete list of Roflumilast side effects or compare Roflumilast side effects

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 (eg, physician, pharmacist). Your health care provider can provide additional clinical information and complete a copy of the side effect reporting form.

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.

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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.
Pulmonary Embolism
on Jan 30, 2014 Male from US , 77 years of age, weighting 145.5 lb, was diagnosed with and was treated with Roflumilast. Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: pulmonary embolism. Roflumilast dosage: 1df. Patient was hospitalized.

Dyspnoea, Chronic Obstructive Pulmonary Disease
Patient was taking Roflumilast. Patient felt the following Roflumilast side effects: dyspnoea, chronic obstructive pulmonary disease on Mar 07, 2014 from US Additional patient health information: Female , 50 years of age, weighting 234.6 lb, was diagnosed with and. Roflumilast dosage: 500 Mcg.
Multiple prescriptions taken:
  • Tiotropium
  • Advair
  • Oxygen
  • Salbutamol
Patient was hospitalized.

Pneumonia
Adverse event was reported on Jan 29, 2014 by a Male taking Roflumilast (Dosage: 500 Mcg) was diagnosed with and. Location: US , 74 years of age, weighting 165.3 lb, After Roflumilast was administered, patient encountered several Roflumilast side effects: pneumonia. Patient was hospitalized.

Pneumonia
on Jan 29, 2014 Male from US , 73 years of age, was treated with Roflumilast. Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: pneumonia. Roflumilast dosage: 500 Mcg. Patient was hospitalized.


Dyspnoea
on Jan 29, 2014 Male from US , 80 years of age, weighting 130.1 lb, was diagnosed with and was treated with Roflumilast. Patient felt the following Roflumilast side effects: dyspnoea. Roflumilast dosage: 500 Mcg.
Multiple prescriptions taken:
  • Seretide
  • Cough Syrup
  • Primalan
  • Ibuprofen
  • Asterol
  • Aspirin Protect
  • Lipitor
  • Herben
Patient was hospitalized.

Abasia, Discomfort, Disorientation, Off Label Use
Patient was taking Roflumilast. After Roflumilast was administered, patient encountered several Roflumilast side effects: abasia, discomfort, disorientation, off label use on Jan 29, 2014 from US Additional patient health information: Male , 72 years of age, was diagnosed with and. Roflumilast dosage: 0.5 Df. Patient was hospitalized.

Chills, Abdominal Discomfort, Dyspepsia, Diarrhoea, Palpitations, Off Label Use
Adverse event was reported on Jan 27, 2014 by a Male taking Roflumilast (Dosage: 1 Df) was diagnosed with and. Location: US , 58 years of age, Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: chills, abdominal discomfort, dyspepsia, diarrhoea, palpitations, off label use.

Weight Decreased
on Jan 27, 2014 Male from US , 80 years of age, weighting 198.4 lb, was diagnosed with and was treated with Roflumilast. Patient felt the following Roflumilast side effects: weight decreased. Roflumilast dosage: 1 Df.
Multiple prescriptions taken:
  • Spiriva
  • Seretide
  • Dianben (850 Mg)
  • Adiro (300 Mg)
  • Exforge Hct
  • Ventolin
  • Oxygen (1.5 L)
  • Omeprazole


Dehydration, Diarrhoea
on Jan 27, 2014 Female from US , 76 years of age, was treated with Roflumilast. After Roflumilast was administered, patient encountered several Roflumilast side effects: dehydration, diarrhoea. Roflumilast dosage: 500 Mcg. Patient was hospitalized.

Confusional State, Hallucination, Nightmare
Patient was taking Roflumilast. Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: confusional state, hallucination, nightmare on Jan 24, 2014 from US Additional patient health information: Male , 83 years of age, was diagnosed with and. Roflumilast dosage: 1df.

H1n1 Influenza
Adverse event was reported on Jan 23, 2014 by a Female taking Roflumilast (Dosage: 500 Mcg) . Location: US , 60 years of age, Patient felt the following Roflumilast side effects: h1n1 influenza.
Multiple prescriptions taken:
  • Prednisone
Patient was hospitalized.

Diarrhoea, Malaise, Decreased Appetite, Insomnia
on Jan 16, 2014 Female from US , 74 years of age, weighting 125.7 lb, was treated with Roflumilast. After Roflumilast was administered, patient encountered several Roflumilast side effects: diarrhoea, malaise, decreased appetite, insomnia. Roflumilast dosage: 500 Mcg.

Diarrhoea, Malaise, Anxiety, Insomnia
on Jan 15, 2014 Male from US , 52 years of age, weighting 143.3 lb, was treated with Roflumilast. Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: diarrhoea, malaise, anxiety, insomnia. Roflumilast dosage: 500 Mcg.

Dyspnoea
Patient was taking Roflumilast. Patient felt the following Roflumilast side effects: dyspnoea on Jan 15, 2014 from COUNTRY NOT SPECIFIED Additional patient health information: Male , 82 years of age, weighting 121.3 lb, was diagnosed with and. Roflumilast dosage: 500 Mcg.
Multiple prescriptions taken:
  • Onbrez
  • Alvesco
  • Symbicort
  • Ventolin
  • Spiriva
  • Atrovent
  • Singulair
  • Aminophylline
Patient was hospitalized.

Chronic Obstructive Pulmonary Disease, Dyspnoea, Dizziness
Adverse event was reported on Jan 14, 2014 by a Male taking Roflumilast (Dosage: 1 Df) was diagnosed with and. Location: US , 54 years of age, weighting 165.3 lb, After Roflumilast was administered, patient encountered several Roflumilast side effects: chronic obstructive pulmonary disease, dyspnoea, dizziness. Patient was hospitalized.

Dyspnoea, Back Pain, Thoracic Vertebral Fracture, Rib Fracture
on Jan 07, 2014 Male from COUNTRY NOT SPECIFIED , 65 years of age, weighting 156.5 lb, was diagnosed with and was treated with Roflumilast. Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: dyspnoea, back pain, thoracic vertebral fracture, rib fracture. Roflumilast dosage: 500 Mcg.
Associated medications used:
  • Gelomyrtol Forte (600 Mg)
  • Ventolin
  • Surfolase
  • Aminophylline
  • Asima
  • Onbrez Breezhaler
  • Foster Hfa (100/6)
  • Levotuss
Patient was hospitalized.

Paranoia, Nightmare
on Jan 02, 2014 Female from US , 60 years of age, was diagnosed with and was treated with Roflumilast. Patient felt the following Roflumilast side effects: paranoia, nightmare. Roflumilast dosage: N/A.

Coronary Artery Occlusion, Condition Aggravated, Chronic Obstructive Pulmonary Disease, Cholecystectomy, Myocardial Infarction, Weight Decreased, Eating Disorder, Ageusia
Patient was taking Roflumilast. After Roflumilast was administered, patient encountered several Roflumilast side effects: coronary artery occlusion, condition aggravated, chronic obstructive pulmonary disease, cholecystectomy, myocardial infarction, weight decreased, eating disorder, ageusia on Jan 27, 2014 from US Additional patient health information: Male , 69 years of age, weighting 172.0 lb, was diagnosed with and. Roflumilast dosage: 500 Mcg.
Multiple concurrent drugs taken:
  • Reliqui
  • Genuair
  • Tepilta
  • Corvaton
  • Novaminsulfon
  • Nebivolol
  • Simvastatin
  • Preterax
Patient was hospitalized.

Dyspnoea, Dysuria, Chest Pain, Benign Renal Neoplasm, Abdominal Pain Upper, Nausea, Anorectal Discomfort, Hypophagia
Adverse event was reported on Dec 27, 2013 by a Female taking Roflumilast (Dosage: 500 Mcg) was diagnosed with and. Location: US , 64 years of age, weighting 81.57 lb, Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: dyspnoea, dysuria, chest pain, benign renal neoplasm, abdominal pain upper, nausea, anorectal discomfort, hypophagia. Patient was hospitalized.

Procedural Complication, Biopsy Lung
on Dec 20, 2013 Female from US , 76 years of age, was treated with Roflumilast. Patient felt the following Roflumilast side effects: procedural complication, biopsy lung. Roflumilast dosage: 500 Mcg. Patient was hospitalized.

Wheezing, Dyspnoea, Productive Cough, Pneumonia
on Dec 18, 2013 Male from US , 88 years of age, weighting 108.0 lb, was diagnosed with and was treated with Roflumilast. After Roflumilast was administered, patient encountered several Roflumilast side effects: wheezing, dyspnoea, productive cough, pneumonia. Roflumilast dosage: 500 Mcg.
Multiple concurrent drugs taken:
  • Onbreze
Patient was hospitalized.

Cardiac Failure, Abdominal Pain, Diarrhoea, Weight Decreased, Off Label Use
Patient was taking Roflumilast. Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: cardiac failure, abdominal pain, diarrhoea, weight decreased, off label use on Dec 13, 2013 from US Additional patient health information: Male , 75 years of age, weighting 194.0 lb, was diagnosed with and. Roflumilast dosage: 500 Df. Patient was hospitalized.


Adverse event was reported on Dec 12, 2013 by a Female taking Roflumilast (Dosage: N/A) . Location: US , weighting 167.6 lb, .
Multiple prescriptions taken:
  • Symbicort
  • Spiriva
  • Salbutamol
  • Theophylline


Tremor, Asthenia
on Dec 12, 2013 Female from US , 71 years of age, was diagnosed with and was treated with Roflumilast. After Roflumilast was administered, patient encountered several Roflumilast side effects: tremor, asthenia. Roflumilast dosage: N/A. Patient was hospitalized.

Dyspnoea
on Dec 10, 2013 Male from US , 63 years of age, weighting 123.5 lb, was diagnosed with and was treated with Roflumilast. Directly after, patient experienced the unwanted or unexpected Roflumilast side effects: dyspnoea. Roflumilast dosage: 1 Df.
Associated medications used:
  • Symbicort
  • Spiriva
  • Seretide
  • Codenal
  • Erdos
  • Anydipine
Patient was hospitalized.

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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

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    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

    Nonthing found, check in later.