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

STRATTERA was administered to 2067 children or adolescent patients with ADHD and 270 adults with ADHD in clinical studies. During the ADHD clinical trials, 169 patients were treated for longer than 1 year and 526 patients were treated for over 6 months.

The data in the following tables and text cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with data obtained from other clinical investigations involving different treatments, uses, or investigators. The cited data provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence in the population studied.

Child and Adolescent Clinical Trials

Reasons for discontinuation of treatment due to adverse events in child and adolescent clinical trials  — In acute child and adolescent placebo-controlled trials, 3.5% (15/427) of atomoxetine subjects and 1.4% (4/294) placebo subjects discontinued for adverse events. For all studies, (including open-label and long-term studies), 5% of extensive metabolizer (EM) patients and 7% of poor metabolizer (PM) patients discontinued because of an adverse event. Among STRATTERA-treated patients, aggression (0.5%, N=2); irritability (0.5%, N=2); somnolence (0.5%, N=2); and vomiting (0.5%, N=2) were the reasons for discontinuation reported by more than 1 patient.

Commonly observed adverse events in acute child and adolescent, placebo-controlled trials  — Commonly observed adverse events 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 1 for the BID trials. Results were similar in the QD trial except as shown in Table 2, which shows both BID and QD results for selected adverse events. The most commonly observed adverse events 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: dyspepsia, nausea, vomiting, fatigue, appetite decreased, dizziness, and mood swings (see  Tables 1 and  2).

Table 1: Common Treatment-Emergent Adverse Events Associated with the Use of STRATTERA in Acute (up to 9 weeks) Child and Adolescent Trials
Adverse Event1 Percentage of Patients Reporting Events from BID Trials
STRATTERA
(N=340)
Placebo
(N=207)

1 Events reported by at least 2% of patients treated with atomoxetine, and greater than placebo. The following events did not meet this criterion but were reported by more atomoxetine-treated patients than placebo-treated patients and are possibly related to atomoxetine treatment: anorexia, blood pressure increased, early morning awakening, flushing, mydriasis, sinus tachycardia, tearfulness. The following events were reported by at least 2% of patients treated with atomoxetine, and equal to or less than placebo: arthralgia, gastroenteritis viral, insomnia, sore throat, nasal congestion, nasopharyngitis, pruritus, sinus congestion, upper respiratory tract infection.

Gastrointestinal Disorders
   Abdominal pain upper2016
   Constipation31
   Dyspepsia42
   Vomiting119
Infections
   Ear infection31
   Influenza31
Investigations
   Weight decreased20
Metabolism and Nutritional Disorders
   Appetite decreased146
Nervous System Disorders
   Dizziness (exc vertigo)63
   Headache2725
   Somnolence75
Psychiatric Disorders
   Crying21
   Irritability85
   Mood swings20
Respiratory, Thoracic, and Mediastinal Disorders
   Cough117
   Rhinorrhea43
Skin and Subcutaneous Tissue Disorders
   Dermatitis41
Table 2: Common Treatment-Emergent Adverse Events Associated with the Use of STRATTERA in Acute (up to 9 weeks) Child and Adolescent Trials
Adverse Event Percentage of Patients Reporting Events from BID TrialsPercentage of Patients Reporting Events from
QD Trials
STRATTERA
(N=340)
Placebo
(N=207)
STRATTERA
(N=85)
Placebo
(N=85)
Gastrointestinal Disorders
   Abdominal pain upper2016169
   Constipation3100
   Diarrhea3641
   Dry mouth1241
   Dyspepsia4280
   Nausea78122
   Vomiting119151
General Disorders
   Fatigue4591
Psychiatric Disorders
   Mood swings2052

The following adverse events 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: decreased appetite (23% of PMs, 16% of EMs); insomnia (13% of PMs, 7% of EMs); sedation (4% of PMs, 2% of EMs); depression (6% of PMs, 2% of EMs); tremor (4% of PMs, 1% of EMs); early morning awakening (3% of PMs, 1% of EMs); pruritus (2% of PMs, 1% of EMs); mydriasis (2% of PMs, 1% of EMs).

Adult Clinical Trials

Reasons for discontinuation of treatment due to adverse events in acute adult placebo-controlled trials  — In the acute adult placebo-controlled trials, 8.5% (23/270) atomoxetine subjects and 3.4% (9/266) placebo subjects discontinued for adverse events. Among STRATTERA-treated patients, insomnia (1.1%, N=3); chest pain (0.7%, N=2); palpitations (0.7%, N=2); and urinary retention (0.7%, N=2) were the reasons for discontinuation reported by more than 1 patient.

Commonly observed adverse events in acute adult placebo-controlled trials — Commonly observed adverse events 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 3. The most commonly observed adverse events in patients treated with STRATTERA (incidence of 5% or greater and at least twice the incidence in placebo patients) were: constipation, dry mouth, nausea, appetite decreased, dizziness, insomnia, decreased libido, ejaculatory problems, impotence, urinary hesitation and/or urinary retention and/or difficulty in micturition, and dysmenorrhea (see  Table 3).

Table 3: Common Treatment-Emergent Adverse Events Associated with the Use of STRATTERA in Acute (up to 10 weeks) Adult Trials
Adverse Event 1Percentage of Patients Reporting Event

System Organ Class/Adverse Event
STRATTERA
(N=269)
Placebo
(N=263)

1 Events reported by at least 2% of patients treated with atomoxetine, and greater than placebo. The following events 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. The following events were reported by at least 2% of patients treated with atomoxetine, and equal to or less than placebo: abdominal pain upper, arthralgia, back pain, cough, diarrhea, influenza, irritability, nasopharyngitis, sore throat, upper respiratory tract infection, vomiting.

2 Based on total number of males (STRATTERA, N=174; placebo, N=172).

3 Based on total number of females (STRATTERA, N=95; placebo, N=91).

Cardiac Disorders
   Palpitations41
Gastrointestinal Disorders
   Constipation104
   Dry mouth216
   Dyspepsia64
   Flatulence21
   Nausea125
General Disorders and Administration Site Conditions
   Fatigue and/or lethargy74
   Pyrexia32
   Rigors31
Infections
   Sinusitis64
Investigations
   Weight decreased21
Metabolism and Nutritional Disorders
   Appetite decreased103
Musculoskeletal, Connective Tissue, and Bone Disorders
   Myalgia32
Nervous System Disorders
   Dizziness62
   Headache1717
   Insomnia and/or middle insomnia168
   Paraesthesia42
   Sinus headache31
Psychiatric Disorders
   Abnormal dreams43
   Libido decreased62
   Sleep disorder42
Renal and Urinary Disorders
   Urinary hesitation and/or urinary retention and/or
   difficulty in micturition
80
   Reproductive System and Breast Disorders
   Dysmenorrhea373
   Ejaculation failure2 and/or ejaculation disorder252
   Erectile disturbance271
   Impotence230
   Menses delayed321
   Menstrual disorder332
   Menstruation irregular320
   Orgasm abnormal21
   Prostatitis230
Skin and Subcutaneous Tissue Disorders
   Dermatitis21
   Sweating increased41
Vascular Disorders
   Hot flushes31

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. The table below displays the incidence of sexual side effects reported by at least 2% of adult patients taking STRATTERA in placebo-controlled trials.

Table 4
 STRATTERAPlacebo

1 Males only.

Erectile disturbance17%1%
Impotence13%0%
Orgasm abnormal2%1%

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 list of undesirable effects (adverse drug reactions) is based on post-marketing spontaneous reports, and corresponding reporting rates have been provided.

Vascular disorders  — Very rare (<0.01%):  Peripheral vascular instability and/or Raynaud's phenomenon (new onset and exacerbation of preexisting condition).



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: 2006-02-23

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

All Rights reserved - Copyright DrugLib.com, 2006-2012