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Strattera

"Jan. 21, 2013 -- The number of children with ADHD is rising rapidly, according to a study of more than 840,000 California children.

While the research findings echo those of nationwide studies, the new study is stronger than some other stud"...

Strattera

Strattera Side Effects Center

Pharmacy Editor: Eni Williams, PharmD, PhD

Strattera (atomoxetine) is a medication that belongs to the drug class called selective norepinephrine reuptake inhibitor. Strattera is available as a generic drug. Strattera is prescribed for treating attention deficit hyperactivity disorder (ADHD). Common side effects of Strattera include trouble sleeping, dry mouth, decreased appetite, upset stomach, nausea or vomiting, dizziness, problems urinating, and sexual side effects.

Strattera dose ranges from 40mg/day to 100mg/day given in 1-2 divided doses. Drug interactions include monoamine oxidase inhibitors (MAOIs) (for example, phenelzine sulfate [Nardil], fluoxetine [Prozac] and quinidine). Strattera may cause severe liver injury. There are no adequate studies of Strattera in pregnant women and it is not known if Strattera is secreted in human breast milk.

Our Strattera Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. articles.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Strattera in Detail - Patient Information: Side Effects

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

Stop taking atomoxetine and call your doctor at once if you have a serious side effect such as:

  • chest pain, shortness of breath, fast or uneven heartbeats;
  • feeling like you might pass out;
  • unusual thoughts or behavior, aggression, hallucinations (seeing things that are not there);
  • nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • increased blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, seizure);
  • urinating less than usual or not at all; or
  • numbness, burning pain, or tingly feeling.

Less serious side effects may include:

  • feeling irritable;
  • feeling dizzy or drowsy;
  • constipation;
  • cough, dry mouth;
  • skin rash or itching;
  • sleep problems (insomnia);
  • increased menstrual cramps; or
  • impotence, loss of interest in sex, or trouble having an orgasm.

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 Strattera (Atomoxetine HCl) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Strattera Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Stomach upset, nausea, vomiting, constipation, tiredness, loss of appetite/weight loss, dry mouth, dizziness, drowsiness, trouble sleeping, or decrease in sexual ability/desire may occur. In women, menstrual cramps or missed/irregular periods may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To lessen the chance of dizziness, get up slowly from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: difficulty urinating, unusually fast/irregular heartbeat, fainting, numbness/tingling.

Atomoxetine may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, stomach/abdominal pain, yellowing eyes/skin.

This medication may rarely cause serious problems such as a heart attack or stroke. Get medical help right away if you experience any of the following: chest/jaw/left arm pain, shortness of breath, unusual sweating, weakness on one side of the body, confusion, slurred speech, sudden vision changes.

Rarely, males (including young boys and teens) may have a painful or prolonged erection lasting 4 or more hours while using this medication. Caregivers/parents should also be watchful for this serious side effect in boys. If a painful or prolonged erection occurs, stop using this drug and get medical help right away, or permanent problems could occur. Ask your doctor or pharmacist for more details.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Strattera (Atomoxetine HCl)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Strattera FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

STRATTERA was administered to 5382 children or adolescent patients with ADHD and 1007 adults with ADHD in clinical studies. During the ADHD clinical trials, 1625 children and adolescent patients were treated for longer than 1 year and 2529 children and adolescent patients were treated for over 6 months.

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.

Child and Adolescent Clinical Trials

Reasons for discontinuation of treatment due to adverse reactions in child and adolescent clinical trials - In acute child and adolescent placebo-controlled trials, 3.0% (48/1613) of atomoxetine subjects and 1.4% (13/945) placebo subjects discontinued for adverse reactions. For all studies, (including open-label and long-term studies), 6.3% of extensive metabolizer (EM) patients and 11.2% of poor metabolizer (PM) patients discontinued because of an adverse reaction. Among STRATTERA-treated patients, irritability (0.3%, N=5); somnolence (0.3%, N=5); aggression (0.2%, N=4); nausea (0.2%, N=4); vomiting (0.2%, N=4); abdominal pain (0.2%, N=4); constipation (0.1%, N=2); fatigue (0.1%, N=2); feeling abnormal (0.1%, N=2); and headache (0.1%, N=2) were the reasons for discontinuation reported by more than 1 patient.

Seizures - STRATTERA has not been systematically evaluated in pediatric patients with seizure disorder as these patients were excluded from clinical studies during the product's premarket testing. In the clinical development program, seizures were reported in 0.2% (12/5073) of children whose average age was 10 years (range 6 to 16 years). In these clinical trials, the seizure risk among poor metabolizers was 0.3% (1/293) compared to 0.2% (11/4741) for extensive metabolizers.

Commonly observed adverse reactions in acute child and adolescent, placebo-controlled trials - Commonly observed adverse reactions associated with the use of STRATTERA (incidence of 2% or greater) and not observed at an equivalent incidence among placebo-treated patients (STRATTERA incidence greater than placebo) are listed in Table 2. Results were similar in the BID and the QD trial except as shown in Table 3, which shows both BID and QD results for selected adverse reactions based on statistically significant Breslow-Day tests. The most commonly observed adverse reactions in patients treated with STRATTERA (incidence of 5% or greater and at least twice the incidence in placebo patients, for either BID or QD dosing) were: nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence (see Tables 2 and 3).

Additional data from ADHD clinical trials (controlled and uncontrolled) has shown that approximately 5 to 10% of pediatric patients experienced potentially clinically important changes in heart rate ( ≥ 20 beats per min) or blood pressure ( ≥ 15 to 20 mm Hg) [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

Table 2: Common Treatment-Emergent Adverse Reactions Associated with the Use of STRATTERA in Acute (up to 18 weeks) Child and Adolescent Trials

Adverse Reactiona Percentage of Patients Reporting Reaction
STRATTERA
(N=1597)
Placebo
(N=934)
Gastrointestinal Disorders
  Abdominal painb 18 10
  Vomiting 11 6
  Nausea 10 5
General Disorders and Administration Site Conditions
  Fatigue 8 3
  Irritability 6 3
  Therapeutic response unexpected 2 1
Investigations
  Weight decreased 3 0
Metabolism and Nutritional Disorders
  Decreased appetite 16 4
  Anorexia 3 1
Nervous System Disorders
  Headache 19 15
  Somnolencec 11 4
  Dizziness 5 2
Skin and Subcutaneous Tissue Disorders
  Rash 2 1
aReactions reported by at least 2% of patients treated with atomoxetine, and greater than placebo. The following reactions did not meet this criterion but were reported by more atomoxetine-treated patients than placebo-treated patients and are possibly related to atomoxetine treatment: blood pressure increased, early morning awakening (terminal insomnia), flushing, mydriasis, sinus tachycardia, asthenia, palpitations, mood swings, constipation, and dyspepsia. The following reactions were reported by at least 2% of patients treated with atomoxetine, and equal to or less than placebo: pharyngolaryngeal pain, insomnia (insomnia includes the terms, insomnia, initial insomnia, middle insomnia). The following reaction did not meet this criterion but shows a statistically significant dose relationship: pruritus.
bAbdominal pain includes the terms: abdominal pain upper, abdominal pain, stomach discomfort, abdominal discomfort, epigastric discomfort.
cSomnolence includes the terms: sedation, somnolence.

Table 3: Common Treatment-Emergent Adverse Reactions Associated with the Use of STRATTERA in Acute (up to 18 weeks) Child and Adolescent Trials

Adverse Reaction Percentage of Patients Reporting Reaction from BID Trials Percentage of Patients Reporting Reaction from QD Trials
STRATTERA
(N=715)
Placebo
(N=434)
STRATTERA
(N=882)
Placebo
(N=500)
Gastrointestinal Disorders
  Abdominal paina 17 13 18 7
  Vomiting 11 8 11 4
  Nausea 7 6 13 4
  Constipationb 2 1 1 0
General Disorders
  Fatigue 6 4 9 2
Psychiatric Disorders
  Mood swingsc 2 0 1 1
aAbdominal pain includes the terms: abdominal pain upper, abdominal pain, stomach discomfort, abdominal discomfort, epigastric discomfort.
bConstipation didn't meet the statistical significance on Breslow-Day test but is included in the table because of pharmacologic plausibility.
cMood swings didn't meet the statistical significance on Breslow-Day test at 0.05 level but p-value was < 0.1 (trend).

The following adverse reactions occurred in at least 2% of PM patients and were either twice as frequent or statistically significantly more frequent in PM patients compared with EM patients: insomnia (15% of PMs, 10% of EMs); weight decreased (7% of PMs, 4% of EMs); constipation (7% of PMs, 4% of EMs); depression1 (7% of PMs, 4% of EMs); tremor (5% of PMs, 1% of EMs); excoriation (4% of PMs, 2% of EMs); conjunctivitis (3% of PMs, 1% of EMs); syncope (3% of PMs, 1% of EMs); early morning awakening (2% of PMs, 1% of EMs); mydriasis (2% of PMs, 1% of EMs).

Adult Clinical Trials

Reasons for discontinuation of treatment due to adverse reactions in acute adult placebo-controlled trials - In the acute adult placebo-controlled trials, 11.3% (61/541) atomoxetine subjects and 3.0% (12/405) placebo subjects discontinued for adverse reactions. Among STRATTERA-treated patients, insomnia (0.9%, N=5); nausea (0.9%, N=5); chest pain (0.6%, N=3); fatigue (0.6%, N=3); anxiety (0.4%, N=2); erectile dysfunction (0.4%, N=2); mood swings (0.4%, N=2); nervousness (0.4%, N=2); palpitations (0.4%, N=2); and urinary retention (0.4%, N=2) were the reasons for discontinuation reported by more than 1 patient.

Seizures - STRATTERA has not been systematically evaluated in adult patients with a seizure disorder as these patients were excluded from clinical studies during the product's premarket testing. In the clinical development program, seizures were reported on 0.1% (1/748) of adult patients. In these clinical trials, no poor metabolizers (0/43) reported seizures compared to 0.1% (1/705) for extensive metabolizers.

Commonly observed adverse reactions in acute adult placebo-controlled trials - Commonly observed adverse reactions associated with the use of STRATTERA (incidence of 2% or greater) and not observed at an equivalent incidence among placebo-treated patients (STRATTERA incidence greater than placebo) are listed in Table 4. The most commonly observed adverse reactions in patients treated with STRATTERA (incidence of 5% or greater and at least twice the incidence in placebo patients) were: constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitation (see Table 4).

Additional data from ADHD clinical trials (controlled and uncontrolled) has shown that approximately 5 to 10% of adult patients experienced potentially clinically important changes in heart rate ( ≥ 20 beats per min) or blood pressure ( ≥ 15 to 20 mm Hg) [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

Table 4: Common Treatment-Emergent Adverse Reactions Associated with the Use of STRATTERA in Acute (up to 25 weeks) Adult Trials

Adverse Reactiona System Organ Class/Adverse Reaction Percentage of Patients Reporting Reaction
STRATTERA
(N=1697)
Placebo
(N=1560)
Cardiac Disorders
  Palpitations 3 1
Gastrointestinal Disorders
  Dry mouth 20 5
  Nausea 26 6
  Constipation 8 3
  Abdominal painb 7 4
  Dyspepsia 4 2
  Vomiting 4 2
General Disorders and Administration Site Conditions
  Fatigue 10 6
  Chills   3 0
  Feeling jittery 2 1
  Irritability   5 3
  Thirst 2 1
Investigations
  Weight decreased 2 1
Metabolism and Nutritional Disorders
  Decreased appetite 16 3
Nervous System Disorders
  Dizziness 8 3
  Somnolencec 8 5
  Paraesthesia 3 0
Psychiatric Disorders
  Abnormal dreams 4 3
  Insomniad   15 8
  Libido decreased 3 1
  Sleep disorder 3 1
Renal and Urinary Disorders
  Urinary hesitatione 6 1
  Dysuria 2 0
Reproductive System and Breast Disorders
  Erectile dysfunctionf 8 1
  Dysmenorrheag 3 2
  Ejaculation delayedf and/or ejaculation disorderf 4 1
Skin and Subcutaneous Tissue Disorders
  Hyperhidrosis 4 1
Vascular Disorders
  Hot flush 3 0
aReactions reported by at least 2% of patients treated with atomoxetine, and greater than placebo. The following reactions did not meet this criterion but were reported by more atomoxetine-treated patients than placebo-treated patients and are possibly related to atomoxetine treatment: peripheral coldness, tachycardia, prostatitis, testicular pain, orgasm abnormal, flatulence, asthenia, feeling cold, muscle spasm, dysgeusia, agitation, restlessness, micturition urgency, pollakiuria, pruritus, urticaria, flushing, tremor, menstruation irregular, rash, and urinary retention. The following reactions were reported by at least 2% of patients treated with atomoxetine, and equal to or less than placebo: anxiety, diarrhea, back pain, headache, and oropharyngeal pain.
bAbdominal pain includes the terms: abdominal pain upper, abdominal pain, stomach discomfort, abdominal discomfort, epigastric discomfort.
cSomnolence includes the terms: sedation, somnolence.
dInsomnia includes the terms: insomnia, initial insomnia, middle insomnia, and terminal insomnia.
eUrinary hesitation includes the terms: urinary hesitation, urine flow decreased.
fBased on total number of males (STRATTERA, N=943; placebo, N=869).
gBased on total number of females (STRATTERA, N=754; placebo, N=691).

Male and female sexual dysfunction - Atomoxetine appears to impair sexual function in some patients. Changes in sexual desire, sexual performance, and sexual satisfaction are not well assessed in most clinical trials because they need special attention and because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling are likely to underestimate the actual incidence. Table 4 above displays the incidence of sexual side effects reported by at least 2% of adult patients taking STRATTERA in placebo-controlled trials.

There are no adequate and well-controlled studies examining sexual dysfunction with STRATTERA treatment. While it is difficult to know the precise risk of sexual dysfunction associated with the use of STRATTERA, physicians should routinely inquire about such possible side effects.

Postmarketing Spontaneous Reports

The following adverse reactions have been identified during post approval use of STRATTERA. Unless otherwise specified, these adverse reactions have occurred in adults and children and adolescents. 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.

Cardiovascular system - QT prolongation, syncope.

Peripheral vascular effects - Raynaud's phenomenon.

General disorders and administration site conditions - Lethargy.

Nervous system disorders - Hypoaesthesia; paraesthesia in children and adolescents; sensory disturbances; tics.

Psychiatric disorders - Depression and depressed mood; anxiety, libido changes.

Seizures - Seizures have been reported in the postmarketing period. The postmarketing seizure cases include patients with pre-existing seizure disorders and those with identified risk factors for seizures, as well as patients with neither a history of nor identified risk factors for seizures. The exact relationship between STRATTERA and seizures is difficult to evaluate due to uncertainty about the background risk of seizures in ADHD patients.

Skin and subcutaneous tissue disorders - Hyperhidrosis.

Urogenital system - Male pelvic pain; urinary hesitation in children and adolescents; urinary retention in children and adolescents.

REFERENCES

1Depression includes the following terms: depression, major depression, depressive symptoms, depressed mood, dysphoria.

Read the entire FDA prescribing information for Strattera (Atomoxetine HCl) »

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Strattera - User Reviews

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