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Daliresp

"COPD is a serious lung disease that makes breathing difficult and worsens over time. Symptoms can include wheezing, cough, chest tightness, and shortness of breath. Cigarette smoking is the leading cause of COPD. According to the National Heart, "...

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

SIDE EFFECTS: Diarrhea, weight loss, stomach/abdominal pain, nausea, loss of appetite, headache, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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 DALIRESPtreated 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 DALIRESP-treated 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 in 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

Postmarketing Experience

The following adverse reactions have been identified from spontaneous reports of DALIRESP received worldwide and have not been listed elsewhere. These adverse reactions have been chosen for inclusion due to a combination of seriousness, frequency of reporting or potential causal connection to DALIRESP. Because these adverse reactions were reported voluntarily from a population of uncertain size, it is not possible to estimate their frequency or establish a causal relationship to DALIRESP exposure: hypersensitivity reactions including angioedema, urticaria, and rash.

Read the entire FDA prescribing information for Daliresp (roflumilast) »

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Daliresp - User Reviews

Daliresp User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Daliresp sorted by most helpful. Patient Discussions FAQs

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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