Slideshows Images Quizzes

Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. See additional information.

Strattera

Last reviewed on RxList: 3/6/2020
Strattera Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Strattera?

Strattera (atomoxetine) is a selective norepinephrine reuptake inhibitor prescribed for treating attention deficit hyperactivity disorder (ADHD). Strattera is available as a generic drug.

What Are Side Effects of Strattera?

Common side effects of Strattera include:

Tell your doctor if you have serious side effects of Strattera including:

Dosage for Strattera

Strattera dose ranges from 40mg/day to 100mg/day given in 1-2 divided doses.

What Drugs, Substances, or Supplements Interact with Strattera?

Strattera may interact with albuterol, amiodarone, bupropion, celecoxib, cimetidine, doxorubicin, methadone, metoclopramide, quinidine, ritonavir, ranitidine, terbinafine, antidepressants, antihistamines, or sleep medicines. Tell your doctor all medication and supplements you use.

Strattera During Pregnancy and Breastfeeding

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. Tell your doctor if you are pregnant or plan to become pregnant or if you are breastfeeding before using Strattera.

Additional Information

Our Strattera 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.

SLIDESHOW

ADHD Symptoms in Children See Slideshow
Strattera Consumer Information

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

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

Atomoxetine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Stop using this medicine and call your doctor at once if you have:

  • signs of heart problems--chest pain, trouble breathing, feeling like you might pass out;
  • signs of psychosis--hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
  • liver problems--stomach pain (upper right side), itching, flu-like symptoms, dark urine, jaundice (yellowing of the skin or eyes);
  • painful or difficult urination; or
  • erection is painful or lasts longer than 4 hours (this is a rare side effect).

Common side effects may include:

  • nausea, vomiting, upset stomach, constipation;
  • dry mouth, loss of appetite;
  • mood changes, feeling tired;
  • dizziness;
  • urination problems; or
  • impotence, trouble having an erection.

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)

QUESTION

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

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
System Organ Class/ Adverse 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
a Reactions 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.
b Abdominal pain includes the terms: abdominal pain upper, abdominal pain, stomach discomfort, abdominal discomfort, epigastric discomfort.
c Somnolence 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
a Abdominal pain includes the terms: abdominal pain upper, abdominal pain, stomach discomfort, abdominal discomfort, epigastric discomfort.
b Constipation didn’t meet the statistical significance on Breslow-Day test but is included in the table because of pharmacologic plausibility.
c Mood 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 child and adolescent CYP2D6 PM patients and were statistically significantly more frequent in PM patients compared with CYP2D6 EM patients: insomnia (11% of PMs, 6% 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); middle insomnia (3% of PMs, 1% 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); sedation (4% of PMs, 2% of EMs).

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

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 Percentage of Patients Reporting Reaction
System Organ Class/ Adverse 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
a Reactions 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.
d Insomnia 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).

The following adverse events occurred in at least 2% of adult CYP2D6 poor metaboliser (PM) patients and were statistically significantly more frequent in PM patients compared to CYP2D6 extensive metaboliser (EM) patients: vision blurred (4% of PMs, 1% of EMs); dry mouth (35% of PMs, 17% of EMs); constipation (11% of PMs, 7% of EMs); feeling jittery (5% of PMs, 2% of EMs); decreased appetite (23% of PMs, 15% of EMs); tremor (5% of PMs, 1% of EMs); insomnia (19% of PMs, 11% of EMs); sleep disorder (7% of PMs, 3% of EMs); middle insomnia (5% of PMs, 3% of EMs); terminal insomnia (3% of PMs, 1% of EMs); urinary retention (6% of PMs, 1% of EMs); erectile dysfunction (21% of PMs, 9% of EMs); ejaculation disorder (6% of PMs, 2% of EMs); hyperhidrosis (15% of PMs, 7% of EMs); peripheral coldness (3% of PMs, 1% of EMs).

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.

Musculoskeletal system - Rhabdomyolysis.

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 - Alopecia, hyperhidrosis.

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

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

Related Resources for Strattera

Read the Strattera User Reviews »

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

SLIDESHOW

ADHD Symptoms in Children See Slideshow

Health Solutions From Our Sponsors

CONTINUE SCROLLING FOR RELATED SLIDESHOW