Irenka

Last updated on RxList: 10/19/2020
Irenka Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Irenka?

Irenka (duloxetine capsule) is a serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant used to treat major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathy, and chronic musculoskeletal pain.

What Are Side Effects of Irenka?

Common side effects of Irenka include:

  • nausea,
  • headache,
  • dry mouth,
  • drowsiness,
  • fatigue,
  • insomnia,
  • constipation,
  • dizziness,
  • diarrhea,
  • decreased appetite,
  • increased sweating, and
  • abdominal pain

Dosage for Irenka

The dose of Irenka is 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily) for major depressive disorder, and 60 mg/day for generalized anxiety disorder, diabetic peripheral neuropathy, and chronic musculoskeletal pain.

What Drugs, Substances, or Supplements Interact with Irenka?

Irenka may interact with monoamine oxidase inhibitors (MAOIs), cimetidine, fluoroquinolone antibiotics, selective serotonin reuptake inhibitors (SSRIs), nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, warfarin, aluminum- and magnesium-containing antacids, theophylline, caffeine, desipramine, alcohol, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's wort. Tell your doctor all medications and supplements you use.

Irenka During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Irenka; it is unknown how it would affect a fetus. Irenka passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Irenka (duloxetine capsule), Delayed Release 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.

QUESTION

Depression is a(n) __________ . See Answer
Irenka Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • pounding heartbeats or fluttering in your chest;
  • a light-headed feeling, like you might pass out;
  • easy bruising, unusual bleeding;
  • vision changes;
  • painful or difficult urination;
  • impotence, sexual problems;
  • liver problems--right-sided upper stomach pain, itching, dark urine, jaundice (yellowing of the skin or eyes);
  • low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady; or
  • manic episodes--racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects may include:

  • drowsiness;
  • nausea, constipation, loss of appetite;
  • dry mouth; or
  • increased sweating.

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 Irenka (Duloxetine Capsules)

SLIDESHOW

Learn to Spot Depression: Symptoms, Warning Signs, Medication See Slideshow
Irenka Professional Information

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in the labeling:

  • Suicidal Thoughts and Behaviors in Children, Adolescents and Young Adults[see BOX WARNING and WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity[see WARNINGS AND PRECAUTIONS]
  • Orthostatic Hypotension, Falls and Syncope[see WARNINGS AND PRECAUTIONS]
  • Serotonin Syndrome[see WARNINGS AND PRECAUTIONS]
  • Abnormal Bleeding[see WARNINGS AND PRECAUTIONS]
  • Severe Skin Reactions[see WARNINGS AND PRECAUTIONS]
  • Discontinuation of Treatment with Irenka[see WARNINGS AND PRECAUTIONS]
  • Activation of Mania/Hypomania[see WARNINGS AND PRECAUTIONS]
  • Angle-Closure Glaucoma[see WARNINGS AND PRECAUTIONS]
  • Seizures[see WARNINGS AND PRECAUTIONS]
  • Effect on Blood Pressure[see WARNINGS AND PRECAUTIONS]
  • Clinically Important Drug Interactions[see WARNINGS AND PRECAUTIONS]
  • Hyponatremia[see WARNINGS AND PRECAUTIONS
  • Urinary Hesitation and Retention[see WARNINGS AND PRECAUTIONS]

Clinical Trial Data Sources

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 stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. Reactions reported during the studies were not necessarily caused by the therapy, and the frequencies do not reflect investigator impression (assessment) of causality.

Adults

The data described below reflect exposure to duloxetine in placebo-controlled trials for MDD (N=3779), GAD (N=1018), OA (N=503), CLBP (N=600), and DPNP (N=906). The population studied was 17 to 89 years of age; 65.7%, 60.8%, 60.6% and 42.9% female; and 81.8%, 72.6%, 85.3%, and 74.0% Caucasian for MDD, GAD, OA and CLBP, and DPNP, respectively. Most patients received doses of a total of 60 to 120 mg per day [see Clinical Studies]. The data below do not include results of the trial examining the efficacy of duloxetine in patients ≥ 65 years old for the treatment of generalized anxiety disorder; however, the adverse reactions observed in this geriatric sample were generally similar to adverse reactions in the overall adult population.

Children And Adolescents

The data described below reflect exposure to duloxetine in pediatric, 10-week, placebo-controlled trials for MDD (N=341) and GAD (N=135). The population studied (N=476) was 7 to 17 years of age with 42.4% children age 7 to 11 years of age, 50.6% female, and 68.6% white. Patients received 30 to 120 mg per day during placebo-controlled acute treatment studies. Additional data come from the overall total of 822 pediatric patients (age 7 to 17 years of age) with 41.7% children age 7 to 11 years of age and 51.8% female exposed to duloxetine in MDD and GAD clinical trials up to 36-weeks in length, in which most patients received 30 to 120 mg per day.

Adverse Reactions Reported As Reasons For Discontinuation Of Treatment In Adult Placebo-Controlled Trials

Major Depressive Disorder

Approximately 8.4% (319/3779) of the patients who received duloxetine in placebo-controlled trials for MDD discontinued treatment due to an adverse reaction, compared with 4.6% (117/2536) of the patients receiving placebo. Nausea (duloxetine 1.1%, placebo 0.4%) was the only common adverse reaction reported as a reason for discontinuation and considered to be drug-related (i.e., discontinuation occurring in at least 1% of the duloxetine treated patients and at a rate of at least twice that of placebo).

Generalized Anxiety Disorder

Approximately 13.7% (139/1018) of the patients who received duloxetine in placebo-controlled trials for GAD discontinued treatment due to an adverse reaction, compared with 5.0% (38/767) for placebo.

Common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (duloxetine 3.3%, placebo 0.4%), and dizziness (duloxetine 1.3%, placebo 0.4%).

Diabetic Peripheral Neuropathic Pain

Approximately 12.9% (117/906) of the patients who received duloxetine in placebo-controlled trials for DPNP discontinued treatment due to an adverse reaction, compared with 5.1% (23/448) for placebo. Common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (duloxetine 3.5%, placebo 0.7%), dizziness (duloxetine 1.2%, placebo 0.4%), and somnolence (duloxetine 1.1%, placebo 0.0%).

Chronic Pain Due To Osteoarthritis

Approximately 15.7% (79/503) of the patients who received duloxetine in 13-week, placebo-controlled trials for chronic pain due to OA discontinued treatment due to an adverse reaction, compared with 7.3% (37/508) for placebo. Common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (duloxetine 2.2%, placebo 1.0%).

Chronic Low Back Pain

Approximately 16.5% (99/600) of the patients who received duloxetine in 13-week, placebo-controlled trials for CLBP discontinued treatment due to an adverse reaction, compared with 6.3% (28/441) for placebo. Common adverse reactions reported as a reason for discontinuation and considered to be drugrelated (as defined above) included nausea (duloxetine 3.0%, placebo 0.7%), and somnolence (duloxetine 1.0%, placebo 0.0%).

Most Common Adult Adverse Reactions

Pooled Trials For All Approved Indications

The most commonly observed adverse reactions in duloxetine -treated patients (incidence of at least 5% and at least twice the incidence in placebo patients) were nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis.

Diabetic Peripheral Neuropathic Pain

The most commonly observed adverse reactions in duloxetine -treated patients (as defined above) were nausea, somnolence, decreased appetite, constipation, hyperhidrosis, and dry mouth.

Chronic Pain Due To Osteoarthritis

The most commonly observed adverse reactions in duloxetine-treated patients (as defined above) were nausea, fatigue, constipation, dry mouth, insomnia, somnolence, and dizziness.

Chronic Low Back Pain

The most commonly observed adverse reactions in duloxetine-treated patients (as defined above) were nausea, dry mouth, insomnia, somnolence, constipation, dizziness, and fatigue.

Adverse Reactions Occurring At An Incidence Of 5% Or More Among Duloxetine-Treated Patients In Adult Placebo-Controlled Trials

Table 2 gives the incidence of treatment-emergent adverse reactions in placebo-controlled trials for approved indications that occurred in 5% or more of patients treated with duloxetine and with an incidence greater than placebo.

Table 2: Treatment-Emergent Adverse Reactions: Incidence of 5% or More and Greater than Placebo in Placebo-Controlled Trials of Approved Indications*

Adverse Reaction Percentage of Patients Reporting Reaction
Duloxetine
(N=8100)
Placebo
(N=5655)
Nauseac 23 8
Headache 14 12
Dry mouth 13 5
Somnolencee 10 3
Fatigueb,c 9 5
Insomniad 9 5
Constipationc 9 4
Dizzinessc 9 5
Diarrhea 9 6
Decreased appetitec 7 2
Hyperhidrosisc 6 1
Abdominal painf 5 4
b Also includes asthenia.
c Events for which there was a significant dose-dependent relationship in fixed-dose studies, excluding three MDD studies which did not have a placebo lead-in period or dose titration.
d Also includes initial insomnia, middle insomnia, and early morning awakening.
e Also includes hypersomnia and sedation.
f Also includes abdominal discomfort, abdominal pain lower, abdominal pain upper, abdominal tenderness, and gastrointestinal pain.
* The inclusion of an event in the table is determined based on the percentages before rounding; however, the percentages displayed in the table are rounded to the nearest integer.

Adverse Reactions Occurring At An Incidence Of 2% Or More Among Duloxetine-Treated Patients In Adult Placebo-Controlled Trials

Pooled MDD And GAD Trials

Table 3 gives the incidence of treatment-emergent adverse reactions in MDD and GAD placebocontrolled trials for approved indications that occurred in 2% or more of patients treated with duloxetine and with an incidence greater than placebo.

Table 3: Treatment-Emergent Adverse Reactions : Incidence of 2% or More and Greater than Placebo in MDD and GAD Placebo-Controlled Trials*,

System Organ Class / Adverse Reaction Percentage of Patients Reporting Reaction
Duloxetine (N=4797) Placebo (N=3303)
Cardiac Disorders
Palpitations 2 1
Eye Disorders
Vision blurred 3 1
Gastrointestinal Disorders
Nauseac 23 8
Dry mouth 14 6
Constipationc 9 4
Diarrhea 9 6
Abdominal paind 5 4
Vomiting 4 2
General Disorders and Administration Site Conditions
Fatiguee 9 5
Metabolism and Nutrition Disorders
Decreased appetitec 6 2
Nervous System Disorders
Headache 14 14
Dizzinessc 9 5
Somnolencef 9 3
Tremor 3 1
Psychiatric Disorders
Insomniag 9 5
Agitationh 4 2
Anxiety 3 2
Reproductive System and Breast Disorders
Erectile dysfunction 4 1
Ejaculation delayedc 2 1
Libido decreasedi 3 1
Orgasm abnormalj 2 <1
Respiratory, Thoracic, and Mediastinal Disorders
Yawning 2 <1
Skin and Subcutaneous Tissue Disorders
Hyperhidrosis 6 2
cEvents for which there was a significant dose-dependent relationship in fixed-dose studies, excluding three MDD studies which did not have a placebo lead-in period or dose titration.
dAlso includes abdominal pain upper, abdominal pain lower, abdominal tenderness, abdominal discomfort, and gastrointestinal pain
eAlso includes asthenia
fAlso includes hypersomnia and sedation
gAlso includes initial insomnia, middle insomnia, and early morning awakening
hAlso includes feeling jittery, nervousness, restlessness, tension and psychomotor hyperactivity
iAlso includes loss of libido
jAlso includes anorgasmia
* The inclusion of an event in the table is determined based on the percentages before rounding; however, the percentages displayed in the table are rounded to the nearest integer.
For GAD, there were no adverse events that were significantly different between treatments in adults ≥65 years that were also not significant in the adults <65 years.

DPNP, OA, And CLBP

Table 4 gives the incidence of treatment-emergent adverse events that occurred in 2% or more of patients treated with duloxetine (determined prior to rounding) in the premarketing acute phase of DPNP, OA, and CLBP placebo-controlled trials and with an incidence greater than placebo.

Table 4: Treatment-Emergent Adverse Reactions : Incidence of 2% or More and Greater than Placebo in DPNP, OA, and CLBP Placebo-Controlled Trials*

System Organ Class / Adverse Reaction Percentage of Patients Reporting Reaction
Duloxetine (N=3303) Placebo (N=2352)
Gastrointestinal Disorders
Nausea 23 7
Dry mouthb 11 3
Constipationb 10 3
Diarrhea 9 5
Abdominal Painc 5 4
Vomiting 3 2
Dyspepsia 2 1
General Disorders and Administration Site Conditions
Fatigued 11 5
Infections and Infestations
Nasopharyngitis 4 4
Upper Respiratory Tract Infection 3 3
Influenza 2 2
Metabolism and Nutrition Disorders
Decreased Appetiteb, 8 1
Musculoskeletal and Connective Tissue
Musculoskeletal Paine 3 3
Muscle Spasms 2 2
Nervous System Disorders
Headache 13 8
Somnolenceb,f 11 3
Dizziness 9 5
Paraesthesiag 2 2
Tremorb 2 <1
Psychiatric Disorders
Insomniab,h 10 5
Agitationi 3 1
Reproductive System and Breast Disorders
Erectile Dysfunctionb 4 <1
Ejaculation Disorderj 2 <1
Respiratory, Thoracic, and Mediastinal Disorders
Cough 2 2
Skin and Subcutaneous Tissue Disorders
Hyperhidrosis 6 1
Vascular Disorders
Flushingk 3 1
Blood pressure increasedl 2 1
bIncidence of 120 mg/day is significantly greater than the incidence for 60 mg/day.
cAlso includes abdominal discomfort, abdominal pain lower, abdominal pain upper, abdominal tenderness and gastrointestinal pain
dAlso includes asthenia
eAlso includes myalgia and neck pain
fAlso includes hypersomnia and sedation
gAlso includes hypoaesthesia, hypoaesthesia facial, genital hypoaesthesia and paraesthesia oral
hAlso includes initial insomnia, middle insomnia, and early morning awakening.
iAlso includes feeling jittery, nervousness, restlessness, tension and psychomotor hyperactivity
jAlso includes ejaculation failure
kAlso includes hot flush
lAlso includes blood pressure diastolic increased, blood pressure systolic increased, diastolic hypertension, essential hypertension, hypertension, hypertensive crisis, labile hypertension, orthostatic hypertension, secondary hypertension, and systolic hypertension
* The inclusion of an event in the table is determined based on the percentages before rounding; however, the percentages displayed in the table are rounded to the nearest integer.

Effects On Male And Female Sexual Function In Adults

Changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of psychiatric disorders or diabetes, but they may also be a consequence of pharmacologic treatment. Because adverse sexual reactions are presumed to be voluntarily underreported, the Arizona Sexual Experience Scale (ASEX), a validated measure designed to identify sexual side effects, was used prospectively in 4 MDD placebo-controlled trials. In these trials, as shown in Table 5 below, patients treated with duloxetine experienced significantly more sexual dysfunction, as measured by the total score on the ASEX, than did patients treated with placebo. Gender analysis showed that this difference occurred only in males. Males treated with duloxetine experienced more difficulty with ability to reach orgasm (ASEX Item 4) than males treated with placebo. Females did not experience more sexual dysfunction on duloxetine than on placebo as measured by ASEX total score. Negative numbers signify an improvement from a baseline level of dysfunction, which is commonly seen in depressed patients. Physicians should routinely inquire about possible sexual side effects.

Table 5: Mean Change in ASEX Scores by Gender in MDD Placebo-Controlled Trials

  Male Patients* Female Patients*
Duloxetine (n=175) Placebo (n=83) Duloxetine (n=241) Placebo (n=126)
ASEX Total (Items 1 to 5) 0.56 -1.07 -1.15 -1.07
Item 1-Sex drive -0.07 -0.12 -0.32 -0.24
Item 2-Arousal 0.01 -0.26 -0.21 -0.18
Item 3-Ability to achieve erection (men); Lubrication (women) 0.03 -0.25 -0.17 -0.18
Item 4-Ease of reaching orgasm 0.40 -0.24 -0.09 -0.13
Item 5-Orgasm satisfaction 0.09 -0.13 -0.11 -0.17
* n=Number of patients with non-missing change score for ASEX total
p=0.013 versus placebo
p<0.001 versus placebo

Vital Sign Changes In Adults

In placebo-controlled clinical trials across approved indications for change from baseline to endpoint, duloxetine treatment was associated with mean increases of 0.23 mm Hg in systolic blood pressure and 0.73 mm Hg in diastolic blood pressure compared to mean decreases of 1.09 mm Hg systolic and 0.55 mm Hg diastolic in placebo-treated patients. There was no significant difference in the frequency of sustained (3 consecutive visits) elevated blood pressure [see WARNINGS AND PRECAUTIONS].

Duloxetine treatment, for up to 26 weeks in placebo-controlled trials across approved indications, typically caused a small increase in heart rate for change from baseline to endpoint compared to placebo of up to 1.37 beats per minute (increase of 1.20 beats per minute in duloxetine-treated patients, decrease of 0.17 beats per minute in placebo-treated patients).

Laboratory Changes In Adults

Duloxetine treatment in placebo-controlled clinical trials across approved indications, was associated with small mean increases from baseline to endpoint in ALT, AST, CPK, alkaline phosphatase; infrequent, modest, transient, abnormal values were observed for these analytes in duloxetine-treated patients when compared with placebo-treated patients [see WARNINGS AND PRECAUTIONS].

High bicarbonate, cholesterol, and abnormal (high or low) potassium, were observed more frequently in duloxetine treated patients compared to placebo.

Electrocardiogram Changes In Adults

The effect of duloxetine 160 mg and 200 mg administered twice daily to steady state was evaluated in a randomized, double-blinded, two-way crossover study in 117 healthy female subjects. No QT interval prolongation was detected. Duloxetine appears to be associated with concentration-dependent but not clinically meaningful QT shortening.

Other Adverse Reactions Observed During The Premarketing And Postmarketing Clinical Trial Evaluation Of Duloxetine In Adults

Following is a list of treatment-emergent adverse reactions reported by patients treated with duloxetine in clinical trials. In clinical trials of all indications, 34,756 patients were treated with duloxetine. Of these, 26.9% (9337) took duloxetine for at least 6 months, and 12.4% (4317) for at least one year. The following listing is not intended to include reactions (1) already listed in previous tables or elsewhere in labeling, (2) for which a drug cause was remote, (3) which were so general as to be uninformative, (4) which were not considered to have significant clinical implications, or (5) which occurred at a rate equal to or less than placebo.

Reactions are categorized by body system according to the following definitions: frequent adverse reactions are those occurring in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000 patients.

Cardiac Disorders

Frequent: palpitations; Infrequent: myocardial infarction and tachycardia.

Ear And Labyrinth Disorders

Frequent: vertigo; Infrequent: ear pain and tinnitus.

Endocrine Disorders

Infrequent: hypothyroidism.

Eye Disorders

Frequent: vision blurred; Infrequent: diplopia, dry eye, and visual impairment.

Gastrointestinal Disorders

Frequent: flatulence; Infrequent: dysphagia, eructation, gastritis, gastrointestinal hemorrhage, halitosis, and stomatitis; Rare: gastric ulcer.

General Disorders And Administration Site Conditions

Frequent: chills/rigors; Infrequent: falls, feeling abnormal, feeling hot and/or cold, malaise, and thirst; Rare: gait disturbance.

Infections And Infestations

Infrequent: gastroenteritis and laryngitis.

Investigations

Frequent: weight increased, weight decreased; Infrequent: blood cholesterol increased.

Metabolism And Nutrition Disorders

Infrequent: dehydration and hyperlipidemia; Rare: dyslipidemia.

Musculoskeletal And Connective Tissue Disorders

Frequent: musculoskeletal pain; Infrequent: muscle tightness and muscle twitching.

Nervous System Disorders

Frequent: dysgeusia, lethargy, and paraesthesia/hypoesthesia; Infrequent: disturbance in attention, dyskinesia, myoclonus, and poor quality sleep; Rare: dysarthria.

Psychiatric Disorders

Frequent: abnormal dreams and sleep disorder; Infrequent: apathy, bruxism, disorientation/confusional state, irritability, mood swings, and suicide attempt; Rare: completed suicide.

Renal And Urinary Disorders

Frequent: urinary frequency; Infrequent: dysuria, micturition urgency, nocturia, polyuria, and urine odor abnormal.

Reproductive System And Breast Disorders

Frequent: anorgasmia/orgasm abnormal; Infrequent: menopausal symptoms, sexual dysfunction, and testicular pain; Rare: menstrual disorder.

Respiratory, Thoracic And Mediastinal Disorders

Frequent: yawning, oropharyngeal pain; Infrequent: throat tightness.

Skin And Subcutaneous Tissue Disorders

Frequent: pruritus; Infrequent: cold sweat, dermatitis contact, erythema, increased tendency to bruise, night sweats, and photosensitivity reaction; Rare: ecchymosis.

Vascular Disorders

Frequent: hot flush; Infrequent: flushing, orthostatic hypotension, and peripheral coldness.

Adverse Reactions Observed In Children And Adolescent Placebo-Controlled Clinical Trials

The adverse drug reaction profile observed in pediatric clinical trials (children and adolescents) was consistent with the adverse drug reaction profile observed in adult clinical trials. The specific adverse drug reactions observed in adult patients can be expected to be observed in pediatric patients (children and adolescents) [see Adverse Reactions Occurring At An Incidence Of 2% Or More Among Duloxetine-Treated Patients In Adult Placebo-Controlled Trials]. The most common (≥5% and twice placebo) adverse reactions observed in pediatric clinical trials include: nausea, diarrhea, decreased weight, and dizziness.

Table 6 provides the incidence of treatment-emergent adverse reactions in MDD and GAD pediatric placebo-controlled trials that occurred in greater than 2% of patients treated with duloxetine and with an incidence greater than placebo.

Table 6: Treatment-Emergent Adverse Reactions : Incidence of 2% or More and Greater than Placebo in three 10 week Pediatric Placebo-Controlled Trials*

System Organ Class /Adverse Reaction Percentage of Pediatric Patients Reporting Reaction
Duloxetine
(N=476)
Placebo
(N=362)
Gastrointestinal Disorders
Nausea 18 8
Abdominal Painb 13 10
Vomiting 9 4
Diarrhea 6 3
Dry Mouth 2 1
General Disorders and Administration Site Conditions
Fatiguec 7 5
Investigations
Decreased Weightd 14 6
Metabolism and Nutrition Disorders
Decreased Appetite 10 5
Nervous System Disorders
Headache 18 13
Somnolencee 11 6
Dizziness 8 4
Psychiatric Disorders
Insomniaf 7 4
Respiratory, Thoracic, and Mediastinal Disorders
Oropharyngeal Pain 4 2
Cough 3 1
bAlso includes abdominal pain upper, abdominal pain lower, abdominal tenderness, abdominal discomfort, and gastrointestinal pain.
cAlso includes asthenia.
dFrequency based on weight measurement meeting potentially clinically significant threshold of ≥3.5% weight loss (N=4 67 Duloxetine; N=354 Placebo).
eAlso includes hypersomnia and sedation.
fAlso includes initial insomnia, insomnia, middle insomnia, and terminal insomnia.
* The inclusion of an event in the table is determined based on the percentages before rounding; however, the percentages displayed in the table are rounded to the nearest integer.

Other adverse reactions that occurred at an incidence of less than 2% but were reported by more duloxetine treated patients than placebo treated patients and are associated duloxetine treatment: abnormal dreams (including nightmare), anxiety, flushing (including hot flush), hyperhidrosis, palpitations, pulse increased, and tremor.

Discontinuation-emergent symptoms have been reported when stopping duloxetine. The most commonly reported symptoms following discontinuation of duloxetine in pediatric clinical trials have included headache, dizziness, insomnia, and abdominal pain [see WARNINGS AND PRECAUTIONS and Adverse Reactions Reported As Reasons For Discontinuation Of Treatment In Adult Placebo-Controlled Trials].

Growth (Height And Weight)

Decreased appetite and weight loss have been observed in association with the use of SSRIs and SNRIs. Pediatric patients treated with duloxetine in clinical trials experienced a 0.1kg mean decrease in weight at 10 weeks, compared with a mean weight gain of approximately 0.9 kg in placebo-treated patients. The proportion of patients who experienced a clinically significant decrease in weight (≥3.5%) was greater in the duloxetine group than in the placebo group (14% and 6%, respectively).

Subsequently, over the 4- to 6-month uncontrolled extension periods, duloxetine-treated patients on average trended toward recovery to their expected baseline weight percentile based on population data from age- and sex-matched peers. In studies up to 9 months, duloxetine-treated pediatric patients experienced an increase in height of 1.7 cm on average (2.2 cm increase in children [7 to 11 years of age] and 1.3 cm increase in adolescents [12 to 17 years of age]). While height increase was observed during these studies, a mean decrease of 1% in height percentile was observed (decrease of 2% in children [7 to 11 years of age] and increase of 0.3% in adolescents [12 to 17 years of age]). Weight and height should be monitored regularly in children and adolescents treated with Irenka.

Postmarketing Spontaneous Reports

The following adverse reactions have been identified during postapproval use of duloxetine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse reactions reported since market introduction that were temporally related to duloxetine therapy and not mentioned elsewhere in labeling include: anaphylactic reaction, aggression and anger (particularly early in treatment or after treatment discontinuation), angioneurotic edema, angle-closure glaucoma, extrapyramidal disorder, galactorrhea, gynecological bleeding, hallucinations, hyperglycemia, hyperprolactinemia, hypersensitivity, hypertensive crisis, muscle spasm, rash, restless legs syndrome, seizures upon treatment discontinuation, supraventricular arrhythmia, tinnitus (upon treatment discontinuation), trismus, and urticaria.

Read the entire FDA prescribing information for Irenka (Duloxetine Capsules)

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

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