Qelbree Side Effects Center

Last updated on RxList: 5/12/2022
Qelbree Side Effects Center

What Is Qelbree?

Qelbree (viloxazine extended-release capsules) is a selective norepinephrine reuptake inhibitor (SNRI) used to treat Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

What Are Side Effects of Qelbree?

Side effects of Qelbree include:

    • drowsiness, • decreased appetite, • fatigue, • nausea, • vomiting, • insomnia, • irritability, • headache, • upper respiratory tract infection, • abdominal pain, and • fever

Dosage for Qelbree

The recommended starting dosage of Qelbree for pediatric patients 6 to 11 years of age is 100 mg once daily. The dose may be adjusted in increments of 100 mg weekly to the maximum recommended dosage of 400 mg once daily.

The recommended starting dosage of Qelbree for pediatric patients 12 to 17 years of age is 200 mg once daily. The dose may be adjusted after 1 week, by an increment of 200 mg, to the maximum recommended dosage of 400 mg once daily.

Qelbree In Children

The safety and effectiveness of Qelbree in pediatric patients 6 to 17 years of age with ADHD have been established based on randomized, placebo-controlled studies in pediatric patients.

The safety and effectiveness of Qelbree have not been established in pediatric patients younger than 6 years old.

Patients treated with Qelbree should be monitored for suicidal thoughts and behavior, and for changes in weight.

What Drugs, Substances, or Supplements Interact with Qelbree?

Qelbree may interact with other medicines such as:

    • monoamine oxidase inhibitors (MAOIs), • sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range (such as alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, and theophylline), • moderate sensitive CYP1A2 substrates (such as clozapine and pirfenidone), • CYP2D6 substrates (such as atomoxetine, desipramine, dextromethorphan, nortriptyline, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, and risperidone), and • CYP3A4 substrates (such as alfentanil, avanafil, buspirone, conivaptan, darifenacin, darunavir, ebastine, everolimus, ibrutinib, lomitapide, lovastatin, midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir, triazolam, vardenafil, and lurasidone)

Tell your doctor all medications and supplements you use.

Qelbree During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Qelbree; it may harm the mother. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed Qelbree during pregnancy. It is unknown if Qelbree passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Qelbree (viloxazine extended-release capsules), for Oral Use 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.

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.

QUESTION

The abbreviated term ADHD denotes the condition commonly known as: See Answer
Qelbree Professional Information

SIDE EFFECTS

The following serious adverse reactions are described in other sections of the labeling:

  • Suicidal Thoughts and Behaviors [see WARNINGS AND PRECAUTIONS]
  • Blood Pressure and Heart Rate Increases [see WARNINGS AND PRECAUTIONS]
  • Activation of Mania or Hypomania [see WARNINGS AND PRECAUTIONS]
  • Somnolence and Fatigue [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

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 of Qelbree has been evaluated in 1118 pediatric patients (6 to 17 years of age) with ADHD exposed to one or more doses in short-term (6 to 8 week), randomized, double-blind, placebo-controlled trials. A total of 682 pediatric patients 6 to 17 years of age were treated for at least 6 months, and 347 pediatric patients 6 to 17 years of age for at least 12 months with Qelbree.

The safety of Qelbree has been evaluated in 189 adult patients (18 to 60 years of age) with ADHD exposed to one or more doses in a short-term (6 week), randomized, double-blind, placebo-controlled trial. A total of 277 adult patients with ADHD have been exposed to one or more doses of Qelbree. Eighty-four adult patients were treated for at least 6 months, and 22 adult patients for at least 12 months.

Pediatric Patients (6 to 17 Years of Age)

The data described below reflect exposure to Qelbree in 826 pediatric patients (6 to 17 years) who participated in randomized, double-blind, placebo-controlled trials with doses ranging from 100 mg to 400 mg. The population (N=826) was 65% male, 35% female, 54% White, 41% Black, 4% multiracial, and 1% other races.

Adverse Reactions Leading To Discontinuation Of Qelbree Treatment: Approximately 3% (n=27) of the 826 patients receiving Qelbree in clinical studies discontinued treatment due to an adverse reaction. The adverse reactions most commonly associated with discontinuation of Qelbree were somnolence (n=5), nausea (n=3), headache (n=2), irritability (n=2), tachycardia (n=2), fatigue (n=2), and decreased appetite (n=2).

Most Common Adverse Reactions (occurring at ≥5% and at least twice the placebo rate for any dose): somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability.

Table 1 lists adverse reactions that occurred in at least 2% of patients treated with Qelbree and more frequently in Qelbree-treated patients than in placebo-treated patients. Table 1 data represents pooled data from pediatric patients 6 to 17 years of age who were enrolled in randomized, placebo-controlled trials of Qelbree.

Table 1: Adverse Reactions Reported in ≥2% of Pediatric Patients (6 to 17 Years of Age) Treated with Qelbree and at a Rate Greater than Placebo-Treated Patients in Placebo-Controlled ADHD Studies

Body System Adverse Reaction Placebo
N=463 (%)
Qelbree
100mg
N=154 (%)
200mg
N=367 (%)
400mg
N=305 (%)
All Qelbree
N=826 (%)
Nervous system disorders
Somnolence* 4 12 16 19 16
Headache* 7 10 11 11 11
Metabolic and nutritional disorders
Decreased appetite 0.4 5 8 8 7
Infections and infestations
Upper respiratory tract infection* 6 5 7 8 7
Body as a Whole - General disorders
Fatigue 2 4 5 9 6
Pyrexia 0.2 3 2 1 2
Gastrointestinal system disorders
Abdominal Pain* 4 3 6 7 5
Nausea 3 1 4 7 5
Vomiting 2 5 3 6 4
Psychiatric disorders
Insomnia* 1 2 5 5 4
Irritability 1 3 2 5 3
*The following terms were combined:
Somnolence: somnolence, lethargy, sedation
Headache: headache, migraine, migraine with aura, tension headache
Upper respiratory tract infection: nasopharyngitis, pharyngitis, sinusitis, upper respiratory tract infection, viral sinusitis, viral upper respiratory tract infection
Abdominal pain: abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper
Insomnia: initial insomnia, insomnia, middle insomnia, poor quality sleep, sleep disorder, terminal insomnia

Effects on Weight: In short-term, controlled studies (6 to 8 weeks), Qelbree-treated patients 6 to 11 years of age gained an average of 0.2 kg, compared to a gain of 1 kg in same-aged patients who received placebo. Qelbreetreated patients 12 to 17 years of age lost an average of 0.2 kg, compared to a weight gain of 1.5 kg in same-aged patients who received placebo. In a long-term open-label extension safety trial, 1097 patients received at least 1 dose of Qelbree. Among the 338 patients evaluated at 12 months, the mean change from baseline in weight-forage z-score was -0.2 (standard deviation of 0.5). In the absence of a control group, it is unclear whether the weight change observed in the long-term open-label extension was attributable to the effect of Qelbree.

Adults

The data described below reflect exposure to Qelbree in 189 adults with ADHD who participated in the flexibledose, randomized, double-blind, placebo-controlled trial with doses ranging from 200 mg to 600 mg. The population (N=189) was 56% male, 44% female, 81% White, 12% Black, 3% Asian, 3% other races and 1% multiracial.

Adverse Reactions Leading to Discontinuation of Qelbree Treatment: Approximately 9% of the 189 patients receiving Qelbree in clinical studies discontinued treatment due to an adverse reaction. The adverse reactions most commonly associated with discontinuation of Qelbree were fatigue (n=4), insomnia (n=3), constipation (n=3), and headache (n=2).

Most Common Adverse Reactions (occurring at ≥5% and at least twice the placebo rate of Qelbree): insomnia, headache, somnolence, fatigue, nausea, decreased appetite, dry mouth, and constipation. Table 2 lists adverse reactions that occurred in at least 2% of patients treated with Qelbree and more frequently in Qelbree-treated patients than in placebo-treated patients. Table 2 represents data from adults with ADHD who were enrolled in a flexible-dose, randomized, placebo-controlled trial of Qelbree at doses of 200 mg to 600 mg.

Table 2: Adverse Reactions Reported in ≥2% of Adults Treated with Qelbree and at a Rate Greater than Placebo-Treated Patients in a Flexible-Dose Placebo-Controlled ADHD Study

Body System Adverse Reaction Placebo
N=183 (%)
Qelbree (200 mg to 600 mg)
N=189 (%)
Psychiatric disorders
Insomnia * 7 23
Irritability 3 4
Nervous system disorders
Headache * 7 17
Somnolence * 2 6
Dizziness 2 4
Gastrointestinal system disorders
Nausea 3 12
Dry mouth 2 10
Constipation 1 6
Vomiting 1 4
Gastrooesophageal reflux disease 1 2
Body as a Whole - General disorders
Fatigue 3 12
Metabolic and nutritional disorders
Decreased appetite 3 10
Cardiac Disorders
Tachycardia 1 4
*The following terms were combined:
Somnolence: somnolence, lethargy, sedation
Headache: headache, migraine, migraine with aura, tension headache
Insomnia: initial insomnia, insomnia, middle insomnia, poor quality sleep, sleep disorder, terminal insomnia

DRUG INTERACTIONS

Drugs Having Clinically Important Interactions With Qelbree

Table 3: Clinically Important Drug Interactions with Qelbree

Monoamine Oxidase Inhibitors (MAOI)
Clinical Impact Concomitant use of Qelbree with an MAOI may lead to a potentially life-threatening hypertensive crisis.
Intervention Concomitant use of Qelbree with an MAOI or within 2 weeks after discontinuing an MAOI is contraindicated [see CONTRAINDICATIONS].
Sensitive CYP1A2 Substrates or CYP1A2 Substrates with a Narrow Therapeutic Range
Clinical Impact Viloxazine is a strong CYP1A2 inhibitor. Concomitant use of viloxazine significantly increases the total exposure, but not peak exposure, of sensitive CYP1A2 substrates [see CLINICAL PHARMACOLOGY], which may increase the risk of adverse reactions associated with these CYP1A2 substrates.
Intervention Coadministration with Qelbree is contraindicated [see CONTRAINDICATIONS].
Moderate Sensitive CYP1A2 Substrate
Clinical Impact Viloxazine is a strong CYP1A2 inhibitor. Concomitant use of viloxazine significantly increases the total, but not peak, exposure of sensitive CYP1A2 substrates [see CLINICAL PHARMACOLOGY], which may increase the risk of adverse reactions associated with these CYP1A2 substrates.
Intervention Not recommended for coadministration with Qelbree. Dose reduction may be warranted if coadministered.
CYP2D6 Substrates
Clinical Impact Viloxazine is a weak inhibitor of CYP2D6, and increases the exposure of CYP2D6 substrates when coadministered [see CLINICAL PHARMACOLOGY].
Intervention Monitor patients for adverse reactions and adjust dosages of CYP2D6 substrates, as clinically indicated.
CYP3A4 Substrates
Clinical Impact Viloxazine is a weak inhibitor of CYP3A4 which increases the exposure of CYP3A4 substrates when coadministered [see CLINICAL PHARMACOLOGY].
Intervention Monitor patients for adverse reactions and adjust dosages of CYP3A4 substrates, as clinically indicated.

Read the entire FDA prescribing information for Qelbree (Viloxazine Extended-release Capsules)

SLIDESHOW

ADHD Symptoms in Children See Slideshow

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

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