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Daliresp

Last reviewed on RxList: 4/25/2017
Daliresp Side Effects Center

Last reviewed on RxList 11/22/2016

Daliresp (roflumilast) is a selective phosphodiesterase 4 (PDE4) inhibitor indicated as a treatment for chronic obstructive pulmonary disease (COPD) in patients who also suffer from chronic bronchitis. Daliresp is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Side effects of Daliresp include:

Tell your doctor if you have serious side effects of Daliresp including:

  • mental/mood changes (such as nervousness, depression, thoughts of suicide),
  • trouble sleeping,
  • shaking (tremors), or
  • fast or irregular heartbeat.

Daliresp is available as a tablet. The recommended dose of Daliresp is one tablet per day, with or without food. Daliresp may interact with birth control pills, cimetidine, conivaptan, imatinib, isoniazid, lidocaine, methoxsalen, primaquine, antidepressants, antibiotics, antifungal medications, heart or blood pressure medications, or HIV/AIDS medicines. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Daliresp. 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. Consult your doctor before breastfeeding.

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.

Daliresp Consumer Information

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)

Daliresp Professional Information

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 1year 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 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), gynecomastia.

Read the entire FDA prescribing information for Daliresp (roflumilast)

Related Resources for Daliresp

Read the Daliresp User Reviews »

© Daliresp Patient Information is supplied by Cerner Multum, Inc. and Daliresp Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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