DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Strattera (Atomoxetine Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Most common adverse reactions (≥5% and at least twice the incidence of placebo patients)

  • Child and Adolescent Clinical Trials – Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence. (6.1)
  • Adult Clinical Trials – Constipation, dry mouth, nausea, fatigue, decreased appetite, insomnia, erectile dysfunction, urinary hesitation and/or urinary retention and/or dysuria, dysmenorrhea, and hot flush. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

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 (5)].

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

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, 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 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).

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, fatigue, decreased appetite, insomnia, erectile dysfunction, urinary hesitation and/or urinary retention and/or dysuria, dysmenorrhea, and hot flush (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 (5)].

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=540)
Placebo
(N=402)
Cardiac Disorders
    Palpitations 3 1
Gastrointestinal Disorders
    Dry mouth 21 7
    Nausea 21 5
    Constipation 9 3
    Abdominal painb 7 5
    Dyspepsia 4 2
    Vomiting 3 2
General Disorders and Administration Site Conditions
    Fatigue 9 4
    Chills 3 1
    Therapeutic response unexpected 3 1
    Feeling jittery 2 0
Investigations
    Weight decreased 2 1
Metabolism and Nutritional Disorders
    Decreased appetite 11 2
Nervous System Disorders
    Dizziness 6 4
    Somnolencec 4 3
    Paraesthesia 3 1
    Sinus headache 3 1
    Tremor 2 0
Psychiatric Disorders
    Insomniad 15 7
    Libido decreased 4 2
    Sleep disorder 3 1
Renal and Urinary Disorders
    Urinary hesitation and/or urinary retention 7 1
    Dysuria 3 0
Reproductive System and Breast Disorders
    Erectile dysfunctione 9 1
    Dysmenorrheaf 6 2
    Ejaculation delayede and/or ejaculation disordere 3 1
    Menstruation irregularf 2 0
Skin and Subcutaneous Tissue Disorders
    Hyperhidrosis 4 1
    Rash 2 1
Vascular Disorders
    Hot flush 8 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: early morning awakening, peripheral coldness, tachycardia, prostatitis, testicular pain, orgasm abnormal, and flatulence. The following reactions were reported by at least 2% of patients treated with atomoxetine, and equal to or less than placebo: headache, pharyngolaryngeal pain, irritability.

b Abdominal pain includes the terms: abdominal pain upper, abdominal pain, stomach discomfort, abdominal discomfort, epigastric discomfort.

c Somnolence includes the terms: sedation, somnolence.

d Insomnia includes the terms: insomnia, initial insomnia, middle insomnia.

e Based on total number of males (STRATTERA, N=326; placebo, N=260).

f Based on total number of females (STRATTERA, N=214; placebo, N=142).

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.

 

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.

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.

 



REPORTS OF SUSPECTED STRATTERA SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Strattera. The information is not vetted and should not be considered as verified clinical evidence.

Possible Strattera side effects / adverse reactions in 23 year old male

Reported by a physician from United States on 2011-10-03

Patient: 23 year old male

Reactions: Thrombosis

Adverse event resulted in: hospitalization

Suspect drug(s):
Strattera

Other drugs received by patient: Nicotine



Possible Strattera side effects / adverse reactions in 12 year old male

Reported by a consumer/non-health professional from United States on 2011-10-07

Patient: 12 year old male

Reactions: Testicular Torsion

Suspect drug(s):
Strattera

Other drugs received by patient: Advair Diskus 100/50



Possible Strattera side effects / adverse reactions in 7 year old male

Reported by a physician from Spain on 2011-10-11

Patient: 7 year old male weighing 21.0 kg (46.2 pounds)

Reactions: Vomiting, Malaise, Nausea, Haematemesis

Suspect drug(s):
Strattera

Other drugs received by patient: Artane; Thiamine Hydrochloride



See index of all Strattera side effect reports >>

Drug label data at the top of this Page last updated: 2013-05-09

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015