Daliresp
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Daliresp
Daliresp Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
Daliresp (roflumilast) is indicated as a treatment for COPD in patients who also suffer from chronic bronchitis. Side effects of Daliresp can include diarrhea, nausea, headache, acute pancreatitis, and acute renal failure. Daliresp is not a bronchodilator and is not indicated for the relief of acute bronchospasm.
Daliresp is available as a tablet. The recommended dose of Daliresp is one tablet per day, with or without food. Side effects of Daliresp are shown to increase with the use of certain oral contraceptives. The risk of such concurrent use should be weighed carefully against benefit. You should talk to you doctor if you are breastfeeding or plan to breastfeed. It is not known if Daliresp passes into your breast milk. You and your healthcare provider should decide if you will take Daliresp or breastfeed. You should not do both.
Our Daliresp (roflumilast) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Daliresp in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
You may have unusual thoughts or behavior, or thoughts about suicide, while taking this medicine. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, depression, trouble sleeping, or if you feel impulsive, or you have thoughts about suicide or hurting yourself.
Call your doctor at once if you have a serious side effect such as:
- rapid and unintended weight loss;
- tremors;
- pain or burning when you urinate;
Less serious side effects may include:
- nausea, diarrhea, stomach pain;
- loss of appetite, minor weight loss;
- dizziness;
- runny or stuffy nose;
- back pain; or
- flu symptoms.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Daliresp (roflumilast) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Daliresp Overview - Patient Information: Side Effects
Check your weight regularly while taking this medication. Tell your doctor right away of any unusual or extreme weight loss.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as nervousness, depression, thoughts of suicide), trouble sleeping, shaking (tremors), fast/irregular heartbeat.
A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Daliresp (roflumilast)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Daliresp FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
The following adverse reactions are described in greater detail in other sections:
- Psychiatric Events Including Suicidality [see WARNINGS AND PRECAUTIONS]
- Weight Decrease [see WARNINGS AND PRECAUTIONS]
Adverse Reactions in Clinical Studies
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data described below reflect exposure of 4438 patients to DALIRESP 500 mcg once daily in four 1-year placebo-controlled trials, two 6-month placebo-controlled trials, and two 6-month drug add-on trials [see Clinical Studies]. In these trials, 3136 and 1232 COPD patients were exposed to DALIRESP 500 mcg once daily for 6 months and 1-year, respectively.
The population had a median age of 64 years (range 40-91), 73% were male, 92.9% were Caucasian, and had COPD with a mean pre-bronchodilator forced expiratory volume in one second (FEV1) of 8.9 to 89.1% predicted. In these trials, 68.5% of the patients treated with DALIRESP reported an adverse reaction compared with 65.3% treated with placebo.
The proportion of patients who discontinued treatment due to adverse reaction was 14.8% for DALIRESP-treated patients and 9.9% for placebo-treated patients. The most common adverse reactions that led to discontinuation of DALIRESP were diarrhea (2.4%) and nausea (1.6%).
Serious adverse reactions, whether considered drug-related or not by the investigators, which occurred more frequently in DALIRESPtreated patients include diarrhea, atrial fibrillation, lung cancer, prostate cancer, acute pancreatitis, and acute renal failure.
Table 1 summarizes the adverse reactions reported by ≥ 2% of patients in the DALIRESP group 8 controlled COPD clinical trials.
Table 1: Adverse Reactions Reported by ≥ 2%
of Patients Treated with DALIRESP 500 mcg daily and Greater Than Placebo
| Adverse Reactions (Preferred Term) | Treatment | |
| DALIRESP (N=4438) n (%) |
Placebo (N=4192) n (%) |
|
| Diarrhea | 420 (9.5) | 113 (2.7) |
| Weight decreased | 331 (7.5) | 89 (2.1) |
| Nausea | 209 (4.7) | 60 (1.4) |
| Headache | 195 (4.4) | 87 (2.1) |
| Back pain | 142 (3.2) | 92 (2.2) |
| Influenza | 124 (2.8) | 112 (2.7) |
| Insomnia | 105 (2.4) | 41 (1.0) |
| Dizziness | 92 (2.1) | 45 (1.1) |
| Decreased appetite | 91 (2.1) | 15 (0.4) |
Adverse reactions that occurred in the DALIRESP group at a frequency of 1 to 2% where rates exceeded that in the placebo group include:
Gastrointestinal disorders - abdominal pain,
dyspepsia, gastritis, vomiting.
Infections and infestations - rhinitis,
sinusitis, urinary tract infection.
Musculoskeletal and connective tissue
disorders - muscle spasms.
Nervous system disorders - tremor.
Psychiatric
disorders - anxiety, depression
Read the entire FDA prescribing information for Daliresp (roflumilast) »
Additional Daliresp Information
Daliresp - User Reviews
Daliresp User Reviews
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Report Problems to the Food and Drug Administration
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.
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