Drizalma Sprinkle
- Generic Name: duloxetine delayed-release capsules
- Brand Name: Drizalma Sprinkle
Drizalma Sprinkle (Duloxetine Delayed-release Capsules) side effects drug center
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Drizalma Sprinkle Side Effects Center
What Is Drizalma Sprinkle?
Drizalma Sprinkle (duloxetine delayed-release capsules) is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for major depressive disorder in adults, generalized anxiety disorder in adults and pediatric patients ages 7 years to 17 years old, diabetic peripheral neuropathic pain in adults, and chronic musculoskeletal pain in adults.
What Are Side Effects of Drizalma Sprinkle?
Common side effects of Drizalma Sprinkle include:
- nausea,
- dry mouth,
- drowsiness,
- constipation,
- decreased appetite, and
- increased sweating
Dosage for Drizalma Sprinkle
The dose of Drizalma Sprinkle is 60 mg daily for most conditions.
What Drugs, Substances, or Supplements Interact with Drizalma Sprinkle?
Drizalma Sprinkle may interact with monoamine oxidase inhibitors (MAOIs), triptans, tricyclic antidepressants, other SNRIs or SSRIs, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John's wort, cimetidine, ciprofloxacin, enoxacin, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, warfarin, quinidine, phenothiazines, type 1C antiarrhythmics, aluminum-and magnesium-containing antacids, famotidine, proton pump inhibitors (PPIs), theophylline, caffeine, centrally acting CNS drugs, highly plasma protein binding drugs, and alcohol. Tell your doctor all medications and supplements you use.
Drizalma Sprinkle During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Drizalma Sprinkle; third trimester use may increase risk of symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, low muscle tone, tremor, irritability) in newborns. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Drizalma Sprinkle passes into breast milk but its effects on nursing infants are unknown. Consult your doctor before breastfeeding.
Additional Information
Our Drizalma Sprinkle (duloxetine delayed-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.
Drizalma Sprinkle 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 Drizalma Sprinkle (Duloxetine Delayed-release Capsules)
Drizalma Sprinkle Professional Information
SIDE EFFECTS
The following adverse reactions are discussed in more detail in other sections of the labeling:
- Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see BOXED 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]
- Increased Risk of Bleeding [see WARNINGS AND PRECAUTIONS]
- Severe Skin Reactions [see WARNINGS AND PRECAUTIONS]
- Discontinuation Syndrome [see WARNINGS AND PRECAUTIONS]
- Activation of Mania/Hypomania [see WARNINGS AND PRECAUTIONS]
- Angle-Closure Glaucoma [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Elevated 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 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 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 delayed-release capsules in placebo-controlled trials for MDD (N = 3779), GAD (N = 1018), OA (N = 503), CLBP (N = 600), and DPNP (N = 906), and another indication (N = 1294). The population studied was 17 to 89 years of age; 65.7%, 60.8%, 60.6%, 42.9%, and 94.4% female; and 81.8%, 72.6%, 85.3%, 74.0%, and 85.7% Caucasian for MDD, GAD, OA and CLBP, DPNP, and another indication, 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 delayed-release 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 delayed-release capsules 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 delayed-release capsules 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 delayed-release capsules 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 delayed-release capsules 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 delayed-release capsules-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 delayed-release capsules 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 delayed-release capsules 3.3%, placebo 0.4%), and dizziness (duloxetine delayed-release capsules 1.3%, placebo 0.4%).
Diabetic Peripheral Neuropathic Pain
Approximately 12.9% (117/906) of the patients who received duloxetine delayed-release capsules 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 delayed-release capsules 3.5%, placebo 0.7%), dizziness (duloxetine delayed-release capsules 1.2%, placebo 0.4%), and somnolence (duloxetine delayed-release capsules 1.1%, placebo 0.0%).
Chronic Pain Due To Osteoarthritis
Approximately 15.7% (79/503) of the patients who received duloxetine delayed-release capsules 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 delayed-release capsules 2.2%, placebo 1.0%).
Chronic Low Back Pain
Approximately 16.5% (99/600) of the patients who received duloxetine delayed-release capsules 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 drug-related (as defined above) included nausea (duloxetine delayed-release capsules 3.0%, placebo 0.7%), and somnolence (duloxetine delayed-release capsules 1.0%, placebo 0.0%).
Most Common Adverse Reactions (Adults)
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 Delayed-Release Capsules Treated Patients In Adult Placebo-Controlled Trials
Table 2 gives the incidence of adverse reactions in placebo-controlled trials for approved indications that occurred in 5% or more of patients treated with duloxetine delayed-release capsules and with an incidence greater than placebo.
Table 2: Adverse Reactions: Incidence of 5% or More and Greater than Placebo in Placebo-Controlled Trials of Approved Indicationsa
| Adverse Reaction | Percentage of Patients Reporting Reaction | |
| Duloxetine delayed-release capsules (N = 8100) | Placebo (N = 5655) | |
| Nauseac | 23 | 8 |
| Headache | 14 | 12 |
| Dry mouth | 13 | 5 |
| Somnolencee | 10 | 3 |
| Fatigue b,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 |
| a 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. 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. | ||
Adverse Reactions Occurring At An Incidence Of 2% Or More Among Duloxetine Delayed-Release Capsules Treated Patients In Adult Placebo-Controlled Trials
Pooled MDD And GAD Trials
Table 3 gives the incidence of adverse reactions in MDD and GAD placebo-controlled trials for approved indications that occurred in 2% or more of patients treated with duloxetine delayed-release capsules and with an incidence greater than placebo.
Table 3: Adverse Reactions: Incidence of 2% or More and Greater than Placebo in MDD and GAD Placebo-Controlled Trialsa,b
| System Organ Class / Adverse Reaction | Percentage of Patients Reporting Reaction | |
| Duloxetine delayed-release capsules (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 decreased | 3 | 1 |
| Orgasm abnormalj | 2 | <1 |
| Respiratory, Thoracic, and Mediastinal Disorders | ||
| Yawning | 2 | <1 |
| Skin and Subcutaneous Tissue Disorders | ||
| Hyperhidrosis | 6 | 2 |
| a 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. b 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. 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 abdominal pain upper, abdominal pain lower, abdominal tenderness, abdominal discomfort, and gastrointestinal pain e Also includes asthenia f Also includes hypersomnia and sedation g Also includes initial insomnia, middle insomnia, and early morning awakening h Also includes feeling jittery, nervousness, restlessness, tension and psychomotor hyperactivity i Also includes loss of libido j Also includes anorgasmia | ||
DPNP, Another Indication, OA, And CLBP
Table 4 gives the incidence of adverse events that occurred in 2% or more of patients treated with duloxetine delayed-release capsules (determined prior to rounding) in the premarketing acute phase of DPNP, another indication, OA, and CLBP placebo-controlled trials and with an incidence greater than placebo.
Table 4: Adverse Reactions: Incidence of 2% or More and Greater than Placebo in DPNP, Another Indication, OA, and CLBP Placebo-Controlled Trialsa
| System Organ Class / Adverse Reaction | Percentage of Patients Reporting Reaction | |
| Duloxetine delayed-release capsules (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 |
| a 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. b Incidence of 120 mg/day is significantly greater than the incidence for 60 mg/day. c Also includes abdominal discomfort, abdominal pain lower, abdominal pain upper, abdominal tenderness and gastrointestinal pain d Also includes asthenia e Also includes myalgia and neck pain f Also includes hypersomnia and sedation g Also includes hypoaesthesia, hypoaesthesia facial, genital hypoaesthesia and paraesthesia oral h Also includes initial insomnia, middle insomnia, and early morning awakening. i Also includes feeling jittery, nervousness, restlessness, tension and psychomotor hyperactivity j Also includes ejaculation failure k Also includes hot flush l Also 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 | ||
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 delayed-release capsules 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 delayed-release capsules 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 delayed-release capsules 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 Patientsa | Female Patientsa | |||
| Duloxetine delayed-release capsules (n = 175) | Placebo (n = 83) | Duloxetine delayed-release capsules (n = 241) | Placebo (n = 126) | |
| ASEX Total (Items 1-5) | 0.56b | -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); | 0.03 | -0.25 | -0.17 | -0.18 |
| Lubrication (women) | ||||
| Item 4 - Ease of reaching orgasm | 0.40c | -0.24 | -0.09 | -0.13 |
| Item 5 - Orgasm satisfaction | 0.09 | -0.13 | -0.11 | -0.17 |
| a n = Number of patients with non-missing change score for ASEX total b p = 0.013 versus placebo c 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 delayed-release capsules 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 delayed-release capsules 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 delayed-release capsules-treated patients, decrease of 0.17 beats per minute in placebo-treated patients).
Laboratory Changes In Adults
Duloxetine delayed-release capsules treatment in placebo-controlled clinical trials across approved indications, was associated with small mean increases from baseline to endpoint in ALT, AST, CPK, and alkaline phosphatase; infrequent, modest, transient, abnormal values were observed for these analytes in duloxetine delayed-release capsules-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 delayed-release capsules treated patients compared to placebo.
Electrocardiogram Changes In Adults
The effect of duloxetine delayed-release capsules 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 delayed-release capsules 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 Delayed-Release Capsules In Adults
Following is a list of adverse reactions reported by patients treated with duloxetine delayed-release capsules in clinical trials. In clinical trials of all indications, 34,756 patients were treated with duloxetine delayed-release capsules. Of these, 26.9% (9337) took duloxetine delayed-release capsules 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, tachycardia, and Takotsubo cardiomyopathy.
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]. 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 adverse reactions in MDD and GAD pediatric placebo-controlled trials that occurred in greater than 2% of patients treated with duloxetine delayed-release capsules and with an incidence greater than placebo.
Table 6: Adverse Reactions: Incidence of 2% or More and Greater than Placebo in three 10 week Pediatric Placebo-Controlled Trialsa
| System Organ Class/Adverse Reaction | Percentage of Pediatric Patients Reporting Reaction | |
| Duloxetine delayed-release capsules (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 |
| a 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. b Also includes abdominal pain upper, abdominal pain lower, abdominal tenderness, abdominal discomfort, and gastrointestinal pain. c Also includes asthenia. d Frequency based on weight measurement meeting potentially clinically significant threshold of ≥3.5% weight loss (N = 467 duloxetine delayed-release capsules; N = 354 Placebo). e Also includes hypersomnia and sedation. f Also includes initial insomnia, insomnia, middle insomnia, and terminal insomnia. | ||
Other adverse reactions that occurred at an incidence of less than 2% but were reported by more duloxetine delayed-release capsules treated patients than placebo treated patients and are associated duloxetine delayed-release capsules 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 delayed-release capsules. The most commonly reported symptoms following discontinuation of duloxetine delayed-release capsules in pediatric clinical trials have included headache, dizziness, insomnia, and abdominal pain [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
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 delayed-release capsules 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 delayed-release capsules group than in the placebo group (14% and 6%, respectively). Subsequently, over the 4 to 6 month uncontrolled extension periods, duloxetine delayed-release capsules-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 delayed-release capsules-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 duloxetine delayed-release capsules.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of duloxetine delayed-release capsules. 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 delayed-release capsules therapy and not mentioned elsewhere in labeling include: acute pancreatitis, anaphylactic reaction, aggression and anger (particularly early in treatment or after treatment discontinuation), angioneurotic edema, angle-closure glaucoma, colitis (microscopic or unspecified), cutaneous vasculitis (sometimes associated with systemic involvement), 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 Drizalma Sprinkle (Duloxetine Delayed-release Capsules)
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