Daliresp

• Generic Name: roflumilast
• Brand Name: Daliresp
• Drug Class: Phosphodiesterase-4 Enzyme Inhibitors

Daliresp (roflumilast) side effects drug center

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• Daliresp User Reviews

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

• Overview
• Consumer Information
• Professional Information

 

Daliresp Side Effects Center

What Is Daliresp?

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.

What Are Side Effects of Daliresp?

Side effects of Daliresp include:

• diarrhea,
• nausea,
• stomach or abdominal pain,
• headache,
• loss of appetite,
• minor weight loss,
• dizziness,
• runny or stuffy nose,
• back pain,
• flu symptoms,
• acute pancreatitis, and
• acute renal failure.

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.

Dosage for Daliresp

Daliresp is available as a tablet. The recommended dose of Daliresp is one tablet per day, with or without food.

What Drugs, Substances, or Supplements Interact with Daliresp?

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.

Daliresp During Pregnancy and Breastfeeding

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.

Additional Information

Our Daliresp (roflumilast) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Daliresp Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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 rapid and unintended weight loss.

• rapid and unintended weight loss;
• tremors;
• pain or burning when you urinate;

Common side effects may include:

• nausea, diarrhea;
• loss of appetite, minor weight loss;
• headache, dizziness;
• occasional sleep problems;
• 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 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

The safety profile of roflumilast reported during Trial 9 was consistent with the key pivotal studies.

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)

&Copy; 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.