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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|
|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 Daliresp (roflumilast) Side Effects Center for a complete guide to possible side effects »
A major step in roflumilast metabolism is the N-oxidation of roflumilast to roflumilast N-oxide by CYP3A4 and CYP1A2 [see CLINICAL PHARMACOLOGY].
Drugs That Induce Cytochrome P450 (CYP) Enzymes
Strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectiveness of DALIRESP. Therefore the use of strong cytochrome P450 inducers (e.g., rifampicin, phenobarbital, carbamazepine, and phenytoin) with DALIRESP is not recommended [see CLINICAL PHARMACOLOGY].
Drugs That Inhibit Cytochrome P450 (CYP) Enzymes
The co-administration of DALIRESP (500 mcg) with CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2simultaneously (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) may increase roflumilast systemic exposure and may result in increased adverse reactions. The risk of such concurrent use should be weighed carefully against benefit. [see CLINICAL PHARMACOLOGY].
Oral Contraceptives Containing Gestodene and Ethinyl Estradiol
The co-administration of DALIRESP (500 mcg) with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast systemic exposure and may result in increased side effects. The risk of such concurrent use should be weighed carefully against benefit [see CLINICAL PHARMACOLOGY].
Last reviewed on RxList: 4/27/2012
This monograph has been modified to include the generic and brand name in many instances.
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