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Roflumilast Side Effects

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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.

Roflumilast Side Effects Reported to FDA



Roflumilast Side Effect Report#9995531
Pyrexia
This is a report of a 77-year-old male patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: chronic obstructive pulmonary disease, who was treated with Roflumilast (dosage: 500 Mcg, start time:
Jul 15, 2013), combined with: NA. and developed a serious reaction and side effect(s): Pyrexia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roflumilast treatment in male patients, resulting in Pyrexia side effect. The patient was hospitalized.
Roflumilast Side Effect Report#9989219
Chronic Obstructive Pulmonary Disease, Nasopharyngitis, Headache, Insomnia, Muscle Strain, Off Label Use
This report suggests a potential Roflumilast Chronic Obstructive Pulmonary Disease side effect(s) that can have serious consequences. A 55-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: chronic obstructive pulmonary disease and used Roflumilast (dosage: 250 Mcg) starting 2009. After starting Roflumilast the patient began experiencing various side effects, including: Chronic Obstructive Pulmonary Disease, Nasopharyngitis, Headache, Insomnia, Muscle Strain, Off Label UseAdditional drugs used concurrently: NA.The patient was hospitalized. Although Roflumilast demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Chronic Obstructive Pulmonary Disease, may still occur.
Roflumilast Side Effect Report#9988004
Breast Cancer
This Breast Cancer problem was reported by a health professional from US. A 81-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Roflumilast (dosage: NA). The following drugs were being taken at the same time: NA. When using Roflumilast, the patient experienced the following unwanted symptoms/side effects: Breast CancerAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Breast Cancer, may become evident only after a product is in use by the general population.
Roflumilast Side Effect Report#9984333
Fall, Nasopharyngitis
This Fall side effect was reported by a health professional from US. A 61-year-old female patient (weight:NA) experienced the following symptoms/conditions: chronic obstructive pulmonary disease.The patient was prescribed Roflumilast (drug dosage: 500 Mcg), which was initiated on
Jun 30, 2013. Concurrently used drugs:
  • Formodual
  • Ventolin
  • Atrovent
  • Flumil Forte
.After starting to take Roflumilast the consumer reported adverse symptoms, such as: Fall, NasopharyngitisThese side effects may potentially be related to Roflumilast. The patient was hospitalized.
Roflumilast Side Effect Report#9983511
Pyrexia, Malaise, Tremor, Nasal Congestion, Cough
This is a report of a 83-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: chronic obstructive pulmonary disease, who was treated with Roflumilast (dosage: 500 Mcg, start time: 2014), combined with: NA. and developed a serious reaction and side effect(s): Pyrexia, Malaise, Tremor, Nasal Congestion, Cough after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roflumilast treatment in male patients, resulting in Pyrexia side effect. The patient was hospitalized.
Roflumilast Side Effect Report#9983502
Apnoea, Heart Rate Increased, Hypertension
This report suggests a potential Roflumilast Apnoea side effect(s) that can have serious consequences. A 74-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: chronic obstructive pulmonary disease and used Roflumilast (dosage: 500 Mcg) starting
Oct 30, 2013. After starting Roflumilast the patient began experiencing various side effects, including: Apnoea, Heart Rate Increased, HypertensionAdditional drugs used concurrently: NA.The patient was hospitalized. Although Roflumilast demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Apnoea, may still occur.
Roflumilast Side Effect Report#9982482
Tremor
This Tremor problem was reported by a pharmacist from US. A 70-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic obstructive pulmonary disease. On
Jan 10, 2014 this consumer started treatment with Roflumilast (dosage: NA). The following drugs were being taken at the same time: NA. When using Roflumilast, the patient experienced the following unwanted symptoms/side effects: TremorAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Tremor, may become evident only after a product is in use by the general population.
Roflumilast Side Effect Report#9980798
Renal Failure Acute, Asthenia, Fatigue, Malaise, Decreased Appetite, Hypophagia, Atrial Fibrillation, Haemodynamic Instability, Blood Pressure Decreased
This Renal Failure Acute side effect was reported by a health professional from US. A 80-year-old male patient (weight:NA) experienced the following symptoms/conditions: b-cell lymphoma.The patient was prescribed Roflumilast (drug dosage: NA), which was initiated on
Jan 28, 2014. Concurrently used drugs: NA..After starting to take Roflumilast the consumer reported adverse symptoms, such as: Renal Failure Acute, Asthenia, Fatigue, Malaise, Decreased Appetite, Hypophagia, Atrial Fibrillation, Haemodynamic Instability, Blood Pressure DecreasedThese side effects may potentially be related to Roflumilast.
Roflumilast Side Effect Report#9975856
Hypertensive Crisis
This is a report of a 62-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: chronic obstructive pulmonary disease, who was treated with Roflumilast (dosage: 500 Mcg, start time: 201402), combined with: NA. and developed a serious reaction and side effect(s): Hypertensive Crisis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roflumilast treatment in female patients, resulting in Hypertensive Crisis side effect. The patient was hospitalized.
Roflumilast Side Effect Report#9969944
Renal Failure Acute, Hypotension, Atrial Fibrillation, Haemodynamic Instability
This report suggests a potential Roflumilast Renal Failure Acute side effect(s) that can have serious consequences. A 80-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: haematological malignancy and used Roflumilast (dosage: NA) starting
Jan 28, 2014. After starting Roflumilast the patient began experiencing various side effects, including: Renal Failure Acute, Hypotension, Atrial Fibrillation, Haemodynamic InstabilityAdditional drugs used concurrently:
  • Normal Saline
  • Amiodarone Drip
Although Roflumilast demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Failure Acute, may still occur.
Roflumilast Side Effect Report#9961846
Renal Failure Acute
This Renal Failure Acute problem was reported by a consumer or non-health professional from US. A 80-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: haematological malignancy. On
Jan 28, 2014 this consumer started treatment with Roflumilast (dosage: NA). The following drugs were being taken at the same time:
  • Normal Saline
When using Roflumilast, the patient experienced the following unwanted symptoms/side effects: Renal Failure AcuteThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Renal Failure Acute, may become evident only after a product is in use by the general population.
Roflumilast Side Effect Report#9961281
Atrial Fibrillation, Dyspnoea, Magnesium Deficiency
This Atrial Fibrillation side effect was reported by a health professional from US. A 74-year-old male patient (weight:NA) experienced the following symptoms/conditions: chronic obstructive pulmonary disease.The patient was prescribed Roflumilast (drug dosage: 500 Mcg), which was initiated on
Jan 13, 2014. Concurrently used drugs:
  • Ultibro
.After starting to take Roflumilast the consumer reported adverse symptoms, such as: Atrial Fibrillation, Dyspnoea, Magnesium DeficiencyThese side effects may potentially be related to Roflumilast. The patient was hospitalized.
Roflumilast Side Effect Report#9949793
Faeces Hard, Frequent Bowel Movements
This is a report of a 75-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: chronic obstructive pulmonary disease, who was treated with Roflumilast (dosage: NA, start time:
Feb 08, 2013), combined with:
  • Terbasmin
and developed a serious reaction and side effect(s): Faeces Hard, Frequent Bowel Movements after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roflumilast treatment in female patients, resulting in Faeces Hard side effect.
Roflumilast Side Effect Report#9934977
Renal Surgery, Inflammation, Food Aversion, Diarrhoea
This report suggests a potential Roflumilast Renal Surgery side effect(s) that can have serious consequences. A 77-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: chronic obstructive pulmonary disease and used Roflumilast (dosage: 500 Mcg) starting
Dec 25, 2012. After starting Roflumilast the patient began experiencing various side effects, including: Renal Surgery, Inflammation, Food Aversion, DiarrhoeaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Roflumilast demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Surgery, may still occur.
Roflumilast Side Effect Report#9929544
Blood Disorder, Acute Myocardial Infarction, Weight Decreased, Frequent Bowel Movements, Diarrhoea, Off Label Use
This Blood Disorder problem was reported by a health professional from US. A 59-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic obstructive pulmonary disease. On
Jun 01, 2011 this consumer started treatment with Roflumilast (dosage: 500 Mcg). The following drugs were being taken at the same time: NA. When using Roflumilast, the patient experienced the following unwanted symptoms/side effects: Blood Disorder, Acute Myocardial Infarction, Weight Decreased, Frequent Bowel Movements, Diarrhoea, Off Label UseThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Blood Disorder, may become evident only after a product is in use by the general population.
Roflumilast Side Effect Report#9924988
Peptic Ulcer, Chronic Obstructive Pulmonary Disease
This Peptic Ulcer side effect was reported by a health professional from Country Not Specified. A 77-year-old male patient (weight:NA) experienced the following symptoms/conditions: chronic obstructive pulmonary disease.The patient was prescribed Roflumilast (drug dosage: 500 Mcg), which was initiated on
Feb 13, 2013. Concurrently used drugs:
  • Spiriva
  • Seretide 500 Discus
  • Erdos
  • Hebron-f
  • Flomox
  • Solondo
  • Aspirin
  • Depas
.After starting to take Roflumilast the consumer reported adverse symptoms, such as: Peptic Ulcer, Chronic Obstructive Pulmonary DiseaseThese side effects may potentially be related to Roflumilast. The patient was hospitalized.
Roflumilast Side Effect Report#9921727
Cataract Operation, Joint Swelling, Pulmonary Congestion
This is a report of a 62-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Roflumilast (dosage: 500 Mcg, start time:
Oct 09, 2013), combined with: NA. and developed a serious reaction and side effect(s): Cataract Operation, Joint Swelling, Pulmonary Congestion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roflumilast treatment in male patients, resulting in Cataract Operation side effect. The patient was hospitalized.
Roflumilast Side Effect Report#9899423
Haemoptysis
This report suggests a potential Roflumilast Haemoptysis side effect(s) that can have serious consequences. A 69-year-old male patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: chronic obstructive pulmonary disease and used Roflumilast (dosage: 500 Mcg) starting
Sep 11, 2012. After starting Roflumilast the patient began experiencing various side effects, including: HaemoptysisAdditional drugs used concurrently:
  • Symbicort Turbuhaler
  • Spiriva Respimat
  • Hebron-f Tab
  • Azeptin Tab
  • Cough Syrup
  • Almagel Tab
The patient was hospitalized. Although Roflumilast demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Haemoptysis, may still occur.
Roflumilast Side Effect Report#9893875
Colon Neoplasm
This Colon Neoplasm problem was reported by a health professional from US. A 78-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: bronchitis chronic. On
Apr 02, 2011 this consumer started treatment with Roflumilast (dosage: 500 Mcg). The following drugs were being taken at the same time:
  • Salbutamol Aldo Union (100 Mcg)
  • Atrovent (20 Mcg)
  • Atorvastatina Normon (10 Mg)
  • Alopurinol Normon (100 Mg)
When using Roflumilast, the patient experienced the following unwanted symptoms/side effects: Colon NeoplasmAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Colon Neoplasm, may become evident only after a product is in use by the general population.
Roflumilast Side Effect Report#9893706
Pneumonia, Weight Decreased
This Pneumonia side effect was reported by a health professional from US. A 70-year-old male patient (weight:NA) experienced the following symptoms/conditions: chronic obstructive pulmonary disease.The patient was prescribed Roflumilast (drug dosage: 500 Mcg), which was initiated on 1999. Concurrently used drugs:
  • Foster
  • Ventolin
.After starting to take Roflumilast the consumer reported adverse symptoms, such as: Pneumonia, Weight DecreasedThese side effects may potentially be related to Roflumilast. The patient was hospitalized.
Roflumilast Side Effect Report#9892265
Asthenia
This is a report of a 53-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: chronic obstructive pulmonary disease, who was treated with Roflumilast (dosage: 250 Mcg, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Asthenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roflumilast treatment in female patients, resulting in Asthenia side effect.
Roflumilast Side Effect Report#9889115
Respiratory Tract Congestion
This report suggests a potential Roflumilast Death side effect(s) that can have serious consequences. A 83-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Roflumilast (dosage: 500 Mcg) starting 201312. After starting Roflumilast the patient began experiencing various side effects, including: Respiratory Tract CongestionAdditional drugs used concurrently: NA.The patient was hospitalized. Although Roflumilast demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Roflumilast Side Effect Report#9863756
Pneumonia, Dyspnoea, Chronic Obstructive Pulmonary Disease
This Pneumonia problem was reported by a health professional from Country Not Specified. A 69-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic obstructive pulmonary disease. On
Jul 10, 2013 this consumer started treatment with Roflumilast (dosage: 500 Mcg). The following drugs were being taken at the same time:
  • Seretide
  • Spiriva Handihaler
  • Aventro (2500 Mg)
  • Ventolin Nebules
  • Nisolone
  • Megace
  • Pantoloc
  • Wafarin
When using Roflumilast, the patient experienced the following unwanted symptoms/side effects: Pneumonia, Dyspnoea, Chronic Obstructive Pulmonary DiseaseThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pneumonia, may become evident only after a product is in use by the general population.
Roflumilast Side Effect Report#9859864
Abdominal Pain Upper, Dry Skin, Muscle Spasms, Investigation
This Abdominal Pain Upper side effect was reported by a health professional from US. A 47-year-old female patient (weight:NA) experienced the following symptoms/conditions: asthma.The patient was prescribed Roflumilast (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Combivent
  • Onbrize
.After starting to take Roflumilast the consumer reported adverse symptoms, such as: Abdominal Pain Upper, Dry Skin, Muscle Spasms, InvestigationThese side effects may potentially be related to Roflumilast. The patient was hospitalized.
Roflumilast Side Effect Report#9859606
This is a report of a 76-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: chronic obstructive pulmonary disease, who was treated with Roflumilast (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roflumilast treatment in male patients, resulting in Death side effect. The patient was hospitalized.


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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.

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What are common Roflumilast Side Effects for Women?

Women Side EffectsReports
Nausea 26
Diarrhoea 25
Dyspnoea 24
Decreased Appetite 17
Weight Decreased 15
Dizziness 14
Headache 13
Malaise 12
Pneumonia 12
Tremor 12

What are common Roflumilast Side Effects for Men?

Men Side EffectsReports
Diarrhoea 37
Weight Decreased 35
Dyspnoea 28
Chronic Obstructive Pulmonary Disease 26
Decreased Appetite 23
Nausea 23
Pneumonia 21
Condition Aggravated 18
Insomnia 18
Anxiety 15

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It is really important to keep track of your health 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

    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.

    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.

    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.

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    More About Roflumilast

    Side Effects reported to FDA: 418

    Roflumilast safety alerts: No

    Reported deaths: 41

    Reported hospitalizations: 155

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