Summary

Commonly reported side effects of atomoxetine include: constipation, insomnia, decreased appetite, and xerostomia. Other side effects include: dermatitis, dysmenorrhea, erectile dysfunction, dizziness, dyspepsia, ejaculatory disorder, urinary hesitancy, ejaculation failure, and diaphoresis. Continue reading for a comprehensive list of adverse effects.

Applies to atomoxetine: oral capsule.

Serious side effects of Atomoxetine

Along with its needed effects, atomoxetine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking atomoxetine:

Less common

• Hives, itching, skin rash
• irregular heartbeat
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• redness of the skin

Rare

• Painful, prolonged erection of your penis

Incidence not known

• Dark colored urine
• fainting
• flu-like symptoms
• irregular heartbeat recurrent
• loss of bladder control
• muscle spasm or jerking of all extremities
• paleness or cold feeling in the fingertips and toes
• pelvic pain in male
• right upper stomach pain or tenderness
• seizures
• sudden loss of consciousness
• tingling or pain in the fingers or toes when exposed to cold
• yellow eyes or skin

Other side effects of Atomoxetine

Some side effects of atomoxetine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach
• belching
• bleeding between periods
• change in amount of bleeding during periods
• change in pattern of monthly periods
• chest tightness
• cough
• decrease in the frequency of urination
• decrease in urine amount
• decreased appetite
• decreased interest in sexual intercourse
• difficulty having a bowel movement (stool)
• difficulty in passing urine (dribbling)
• dizziness
• dry mouth
• fever
• headache
• heartburn
• heavy bleeding
• inability to have or keep an erection
• indigestion
• irritability
• loss in sexual ability, desire, drive, or performance
• nausea
• pain or tenderness around the eyes and cheekbones
• painful urination
• sleepiness or unusual drowsiness
• stomach discomfort, upset, cramps, or pain
• stuffy or runny nose
• trouble breathing
• trouble sleeping
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• unusual stopping of menstrual bleeding
• vomiting

Less common

• Abnormal dreams
• abnormal orgasm
• back pain
• blistering, crusting, irritation, itching, or reddening of the skin
• bloated or full feeling
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in hearing
• change or problem with discharge of semen
• chills
• cold sweats
• confusion
• cough
• cracked, dry, or scaly skin
• crying
• decreased weight
• diarrhea
• difficulty with moving
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• ear drainage
• earache or pain in the ear
• excess air or gas in the stomach or intestines
• feeling of warmth, redness of the face, neck, arms, and occasionally, upper chest
• feeling unusually cold
• frequent urination
• general feeling of discomfort or illness
• groin pain
• increased or sudden sweating
• joint pain
• loss of appetite
• mood swings
• muscle aches, cramping, pains, or stiffness
• pain or burning with urination
• passing gas
• shivering
• sinus headache
• sleep disorder
• swelling of the skin
• swollen joints
• swollen, tender prostate

Incidence not known

• Loss or thinning of the hair

For Healthcare Professionals

Applies to atomoxetine: oral capsule.

Gastrointestinal

Very common (10% or more): Dry mouth (up to 35%), nausea (up to 26%), abdominal pain/discomfort (up to 18%), constipation (up to 11%), vomiting (up to 11%)

Common (1% to 10%): Dyspepsia, gastroenteritis, diarrhea, flatulence^[Ref]

Metabolic

Very common (10% or more): Decreased appetite (up to 24%)

Common (1% to 10%): Decreased weight, anorexia^[Ref]

Cardiovascular

Very common (10% or more): Increased heart rate (up to 23.4%), increased blood pressure (up to 21.5%)

Common (1% to 10%): Orthostatic hypotension, palpitations, flushing/hot flush, sinus tachycardia, tachycardia

Uncommon (0.1% to 1%): QT interval prolongation

Rare (less than 0.1%): Raynaud's phenomenon and/or peripheral vascular instability

Frequency not reported: Myocardial infarction^[Ref]

Endocrine

Very common (10% or more): Erectile dysfunction (up to 21%)

Common (1% to 10%): Dysmenorrhea, delayed ejaculation/ejaculation disorder/ejaculation failure, sexual dysfunction, impotence, prostatitis, abnormal orgasm, irregular menstruation, testicular pain, male genital pain

Postmarketing reports: Priapism, male pelvic pain^[Ref]

Nervous system

Very common (10% or more): Headache (up to 19%), somnolence/sedation (up to 11%)

Common (1% to 10%): Dizziness, tremor, syncope/syncope vasovagal, paraesthesia, feeling jittery, dysgeusia

Uncommon (0.1% to 1%): Seizures, hypoesthesia

Frequency not reported: Stroke^[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 19%)

Common (1% to 10%): Aggression/hostility, irritability, mood swings, depression/depressed mood, early morning awakening, abnormal dreams, decreased libido, sleep disorder, agitation, anxiety

Uncommon (0.1% to 1%): Suicide-related behavior (suicide attempts, suicidal ideation), psychotic/manic symptoms (e.g., hallucinations, delusional thinking, mania), restlessness, emotional lability, generalized anxiety disorder

Frequency not reported: Panic attacks, impulsivity, akathisia, hypomania

Postmarketing reports: Tics, libido changes, sensory disturbances, completed suicide^[Ref]

Dermatologic

Very common (10% or more): Hyperhidrosis (up to 15%)

Common (1% to 10%): Rash, excoriation, dermatitis, pruritus

Uncommon (0.1% to 1%): Urticaria^[Ref]

Other

Very common (10% or more): Fatigue (up to 10%)

Common (1% to 10%): Unexpected therapeutic response, chills, thirst, peripheral coldness/feeling cold, influenza, pyrexia, rigors, lethargy, asthenia, chest pain

Frequency not reported: Delayed growth (height and weight), sudden death^[Ref]

Genitourinary

Common (1% to 10%): Urinary retention, urinary hesitation/decreased urine flow, dysuria, pollakiuria

Uncommon (0.1% to 1%): Micturition urgency, enuresis^[Ref]

Ocular

Common (1% to 10%): Conjunctivitis, mydriasis, blurred vision^[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infection

Uncommon (0.1% to 1%): Pharyngitis, dyspnea

Frequency not reported: Pharyngolaryngeal pain, oropharyngeal pain^[Ref]

Hepatic

Uncommon (0.1% to 1%): Increased blood bilirubin

Rare (less than 0.1%): Liver failure, abnormal/increased liver function tests, jaundice, hepatitis, liver injury, acute hepatic failure^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reactions (anaphylactic reactions, angioneurotic edema, urticarial, rash)^[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Muscle spasms

Frequency not reported: Back pain

Postmarketing reports: Rhabdomyolysis^[Ref]