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Strattera Side Effects

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Strattera Safety Reports reported to FDA

Total Strattera reports: 657.
Strattera FDA safety alerts: 2004 2005 .
Reported deaths: 39    Reported hospitalizations: 181.
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Reported Strattera Side Effects: suicidal ideation, aggression, convulsion, suicide attempt, alanine aminotransferase increased, loss of consciousness, nausea, syncope, aspartate aminotransferase increased, abnormal behaviour, fatigue.
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< Previous  Showing 101-150 of 657 Next >

Strattera Side Effects Report #5259226-X
Physician from UNITED STATES reported STRATTERA problem on Feb 22, 2007. Female patient, 31 years of age, weighting 146.3 lb, was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: autoimmune hepatitis, hepatitis cholestatic, hepatitis viral, jaundice, liver disorder, nausea. STRATTERA dosage: 40 MG, DAILY (1/D). During the same period patient was treated with WELLBUTRIN. Patient recovered.

Strattera Side Effects Report #5259595-0
STRATTERA problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 07, 2007. Male patient, 25 years of age, weighting 155.0 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: visual acuity reduced. STRATTERA dosage: unknown. Patient recovered.

Strattera Side Effects Report #5260751-6
Physician from AUSTRALIA reported STRATTERA problem on Feb 23, 2007. Male patient, child 7 years of age, weighting 57.32 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: supraventricular tachycardia. STRATTERA dosage: 10 MG, DAILY (1/D). Patient recovered.

Strattera Side Effects Report #5263266-4
STRATTERA problem was reported by a Physician from UNITED STATES on Feb 26, 2007. Male patient, child 5 years of age, was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: hydronephrosis. STRATTERA dosage: unknown. During the same period patient was treated with RISPERDAL. Patient was hospitalized. Patient recovered.

Strattera Side Effects Report #5263270-6
Physician from UNITED STATES reported STRATTERA problem on Feb 26, 2007. Male patient, 21 years of age, was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: convulsion, loss of consciousness. STRATTERA dosage: unknown. During the same period patient was treated with AMNESTEEM. Patient recovered.

Strattera Side Effects Report #5263273-1
STRATTERA problem was reported by a Consumer or non-health professional from UNITED STATES on Feb 26, 2007. Male patient, child 7 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: dehydration, dysarthria, fatigue, headache, heart rate increased, lethargy, neck pain, oral discharge. STRATTERA dosage: 18 MG, DAILY (1/D). During the same period patient was treated with ACETAMINOPHEN. Patient was hospitalized. Patient recovered.

Strattera Side Effects Report #5263275-5
Physician from GERMANY reported STRATTERA problem on Feb 26, 2007. Male patient, 28 years of age, weighting 191.8 lb, was diagnosed with attention deficit/hyperactivity disorder, diabetes mellitus insulin-dependent and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia. STRATTERA dosage: 60 MG, DAILY (1/D). During the same period patient was treated with HUMALOG, EFEROX. Patient recovered.

Strattera Side Effects Report #5264048-X
STRATTERA problem was reported by a Physician from UNITED KINGDOM on Feb 27, 2007. Male patient, child 5 years of age, weighting 50.16 lb, was diagnosed with attention deficit/hyperactivity disorder, ear infection, chest discomfort and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, anxiety, blood pressure increased, fear, hallucination. STRATTERA dosage: 10 MG, UNK. During the same period patient was treated with AMOXICILLIN, BECOTIDE, FISH OIL, VENTOLIN. Patient recovered.

Strattera Side Effects Report #5265307-7
Physician from UNITED STATES reported STRATTERA problem on Feb 28, 2007. Male patient, 15 years of age, was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: jaundice, liver function test abnormal. STRATTERA dosage: unknown. Patient recovered.

Strattera Side Effects Report #5265339-9
STRATTERA problem was reported by a Physician from UNITED STATES on Feb 28, 2007. Male patient, 19 years of age, weighting 154.3 lb, was diagnosed with attention deficit/hyperactivity disorder, sedation and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, aggression, agitation, cardiac murmur, depressed level of consciousness, electrocardiogram qt prolonged, hallucination, auditory, hallucination, visual, intentional overdose. STRATTERA dosage: 1200 MG, OTHER. During the same period patient was treated with OLANZAPINE, OXCARBAZEPINE, QUETIAPINE FUMARATE, PAROXETINE, ALBUTEROL, MONTELUKAST, ATIVAN. Patient was hospitalized. Patient recovered.

Strattera Side Effects Report #5266340-1
Physician from CANADA reported STRATTERA problem on Mar 01, 2007. Male patient was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: educational problem, fatigue, impulsive behaviour. STRATTERA dosage: 60 MG, UNK. Patient recovered.

Strattera Side Effects Report #5266379-6
STRATTERA problem was reported by a Physician from UNITED KINGDOM on Mar 02, 2007. Male patient, child 10 years of age, weighting 68.34 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: confusional state, cyanosis, depression, feeling abnormal, feeling cold, loss of consciousness, malaise, nasopharyngitis, pallor. STRATTERA dosage: 40 MG, DAILY (1/D). Patient recovered.

Strattera Side Effects Report #5269038-9
Physician from UNITED KINGDOM reported STRATTERA problem on Mar 05, 2007. Female patient, 15 years of age, weighting 83.99 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: intentional overdose, mydriasis, tachycardia. STRATTERA dosage: 50 MG, DAILY (1/D). During the same period patient was treated with RITALIN. Patient was hospitalized. Patient recovered.

Strattera Side Effects Report #5269074-2
STRATTERA problem was reported by a Physician from UNITED STATES on Mar 05, 2007. Male patient, 16 years of age, was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: skin discolouration. STRATTERA dosage: 80 MG, DAILY (1/D). Patient recovered.

Strattera Side Effects Report #5269076-6
Physician from UNITED STATES reported STRATTERA problem on Mar 05, 2007. Female patient, 14 years of age, was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: hypoaesthesia, skin discolouration. STRATTERA dosage: 80 MG, DAILY (1/D). Patient recovered.

Strattera Side Effects Report #5269077-8
STRATTERA problem was reported by a Physician from UNITED STATES on Mar 05, 2007. Male patient, 15 years of age, was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: peripheral coldness, skin discolouration. STRATTERA dosage: 80 MG, DAILY (1/D). Patient recovered.

Strattera Side Effects Report #5269084-5
Physician from CANADA reported STRATTERA problem on Mar 07, 2007. Male patient, 17 years of age, weighting 141.1 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, blood creatine phosphokinase increased, fatigue, high density lipoprotein decreased, malaise. STRATTERA dosage: 40 MG, DAILY (1/D). Patient recovered.

Strattera Side Effects Report #5270110-8
STRATTERA problem was reported by a Physician from GERMANY on Mar 06, 2007. Male patient, 28 years of age, weighting 191.8 lb, was diagnosed with attention deficit/hyperactivity disorder, diabetes mellitus insulin-dependent and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia, vomiting. STRATTERA dosage: 40 MG, DAILY (1/D). During the same period patient was treated with HUMALOG, EFEROX. Patient recovered.

Strattera Side Effects Report #5271389-9
Consumer or non-health professional from UNITED STATES reported STRATTERA problem on Mar 07, 2007. Male patient, 19 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: abdominal discomfort, blood lactate dehydrogenase increased, cough, sputum abnormal. STRATTERA dosage: 80 MG, UNK. Patient recovered.

Strattera Side Effects Report #5271392-9
STRATTERA problem was reported by a Physician from PUERTO RICO on Mar 09, 2007. Male patient, child 9 years of age, weighting 74.99 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: completed suicide, injury asphyxiation. STRATTERA dosage: 18 MG, UNK. Patient died on 12/05/2005.

Strattera Side Effects Report #5271399-1
Physician from UNITED STATES reported STRATTERA problem on Mar 07, 2007. Female patient was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: ileus, oedema. STRATTERA dosage: 100 MG, UNK. During the same period patient was treated with LEXAPRO, NEXIUM, CLARINEX, HYDROCHLOROTHIAZIDE. Patient was hospitalized. Patient recovered.

Strattera Side Effects Report #5272320-2
STRATTERA problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 20, 2007. Male patient, child 8 years of age, weighting 50.00 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: heart rate increased. STRATTERA dosage: 18MG 1 DAILY FOR 4 DAYS PO. Patient recovered.

Strattera Side Effects Report #5273385-4
Physician from GERMANY reported STRATTERA problem on Mar 12, 2007. Male patient, child 12 years of age, weighting 114.4 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: depression, intentional self-injury, suicidal ideation. STRATTERA dosage: 25 MG, EACH MORNING. Patient recovered.

Strattera Side Effects Report #5276240-9
STRATTERA problem was reported by a Physician from UNITED STATES on Mar 12, 2007. Male patient, child 10 years of age, was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: chest pain, supraventricular tachycardia. STRATTERA dosage: 36 MG, DAILY (1/D). Patient recovered.

Strattera Side Effects Report #5276243-4
Physician from UNITED KINGDOM reported STRATTERA problem on Mar 12, 2007. Male patient, 13 years of age, weighting 123.5 lb, was diagnosed with attention deficit/hyperactivity disorder, epilepsy and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: anaphylactoid reaction, confusional state, dizziness, feeling cold, hyperhidrosis, loss of consciousness, rash erythematous, somnolence, vertigo. STRATTERA dosage: 25 MG, UNK. During the same period patient was treated with TEGRETOL, RITALIN, CONCERTA. Patient recovered.

Strattera Side Effects Report #5277794-9
STRATTERA problem was reported by a Physician from AUSTRIA on Mar 14, 2007. Female patient, 16 years of age, weighting 161.6 lb, was diagnosed with attention deficit/hyperactivity disorder, aggression and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: impulse-control disorder, restlessness, sleep disorder. STRATTERA dosage: 72 MG, DAILY (1/D). During the same period patient was treated with TRUXAL. Patient was hospitalized. Patient recovered.

Strattera Side Effects Report #5279129-4
Pharmacist from UNITED STATES reported STRATTERA problem on Mar 27, 2007. Male patient, child 7 years of age, weighting 48.50 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: aggression, mania. STRATTERA dosage: 60 MG DAILY PO. Patient was hospitalized and became disabled. Patient recovered.

Strattera Side Effects Report #5279428-6
STRATTERA problem was reported by a Physician from UNITED STATES on Mar 14, 2007. Male patient, child 10 years of age, was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: accident, dysphagia, trismus. STRATTERA dosage: unknown. During the same period patient was treated with ZOLOFT, RISPERDAL. Patient recovered.

Strattera Side Effects Report #5279429-8
Physician from UNITED KINGDOM reported STRATTERA problem on Mar 14, 2007. Male patient, 15 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: depression, psychomotor retardation, social avoidant behaviour, tearfulness. STRATTERA dosage: 70 MG, UNK. During the same period patient was treated with CANNABIS. Patient recovered.

Strattera Side Effects Report #5280388-2
STRATTERA problem was reported by a Physician from CANADA on Mar 14, 2007. Male patient, child 9 years of age, was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: electrocardiogram qt prolonged. STRATTERA dosage: unknown. Patient recovered.

Strattera Side Effects Report #5280799-5
Consumer or non-health professional from UNITED STATES reported STRATTERA problem on Mar 15, 2007. Male patient, 13 years of age, was diagnosed with attention deficit/hyperactivity disorder, blood growth hormone and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: conduct disorder, convulsion, gaze palsy, tremor, unresponsive to stimuli. STRATTERA dosage: 25 MG, DAILY (1/D). During the same period patient was treated with HUMATROPE. Patient recovered.

Strattera Side Effects Report #5280800-9
STRATTERA problem was reported by a Physician from UNITED STATES on Mar 16, 2007. Male patient, child 7 years of age, was diagnosed with attention deficit/hyperactivity disorder, sleep disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: aggression, convulsion, pyromania, snoring, somnolence. STRATTERA dosage: 2 MG/KG, UNK. During the same period patient was treated with ZOLOFT, RISPERDAL, MELATONIN. Patient was hospitalized. Patient recovered.

Strattera Side Effects Report #5280803-4
Physician from UNITED STATES reported STRATTERA problem on Mar 16, 2007. Male patient, 14 years of age, weighting 119.5 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: chest pain, dizziness, dyspnoea, electrocardiogram abnormal, epistaxis, loss of consciousness, panic attack, rhinitis allergic, scleritis. STRATTERA dosage: 60 MG, UNK. During the same period patient was treated with WELLBUTRIN. Patient recovered.

Strattera Side Effects Report #5283665-4
STRATTERA problem was reported by a Health Professional from UNITED STATES on Mar 29, 2007. Male patient, 44 years of age, weighting 195.0 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, aggression, agitation, amnesia, insomnia, poor quality sleep, psychotic disorder. STRATTERA dosage: unknown. Patient recovered.

Strattera Side Effects Report #5283068-2
Physician from UNITED STATES reported STRATTERA problem on Mar 19, 2007. Male patient, 21 years of age, was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: convulsion, loss of consciousness. STRATTERA dosage: unknown. During the same period patient was treated with AMNESTEEM. Patient recovered.

Strattera Side Effects Report #5283072-4
STRATTERA problem was reported by a Physician from UNITED STATES on Mar 19, 2007. Male patient, 15 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: abdominal pain, chromaturia, fatigue, jaundice, liver function test abnormal, prescribed overdose. STRATTERA dosage: 60 MG, EACH MORNING. Patient recovered.

Strattera Side Effects Report #5283073-6
Physician from UNITED STATES reported STRATTERA problem on Mar 20, 2007. Female patient, 25 years of age, was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: dizziness postural, syncope. STRATTERA dosage: unknown. Patient recovered.

Strattera Side Effects Report #5283107-9
STRATTERA problem was reported by a Physician from AUSTRIA on Mar 20, 2007. Male patient, child 9 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: decreased appetite, rash. STRATTERA dosage: 18 MG, DAILY (1/D). Patient recovered.

Strattera Side Effects Report #5283115-8
Consumer or non-health professional from UNITED STATES reported STRATTERA problem on Mar 21, 2007. Male patient, child 10 years of age, weighting 125.0 lb, was diagnosed with attention deficit/hyperactivity disorder, anxiety and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: feeling abnormal, head injury, loss of consciousness, post concussion syndrome. STRATTERA dosage: 40 MG, UNK. During the same period patient was treated with KLONOPIN. Patient recovered.

Strattera Side Effects Report #5283117-1
STRATTERA problem was reported by a Physician from IRELAND on Mar 20, 2007. Male patient, 14 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: abdominal pain, gastric ulcer. STRATTERA dosage: 25 MG, UNK. Patient recovered.

Strattera Side Effects Report #5283121-3
Physician from UNITED STATES reported STRATTERA problem on Mar 20, 2007. Male patient, 22 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: haematemesis. STRATTERA dosage: 40 MG, UNK. During the same period patient was treated with NARCAN, NEURONTIN, RITALIN, ULTRAM. Patient recovered.

Strattera Side Effects Report #5283133-X
STRATTERA problem was reported by a Physician from GERMANY on Mar 21, 2007. Male patient, 15 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: migraine with aura. STRATTERA dosage: 18 MG, DAILY (1/D). During the same period patient was treated with MEDIKINET. Patient was hospitalized. Patient recovered.

Strattera Side Effects Report #5288769-8
Physician from GERMANY reported STRATTERA problem on Mar 23, 2007. Male patient, child 12 years of age, weighting 114.4 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: intentional self-injury, suicidal ideation. STRATTERA dosage: 25 MG, EACH MORNING. Patient recovered.

Strattera Side Effects Report #5288771-6
STRATTERA problem was reported by a Physician from UNITED KINGDOM on Mar 22, 2007. Male patient, child 10 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: apathy, chills, diarrhoea, feeling cold, headache, influenza like illness, insomnia, pain in extremity, pollakiuria. STRATTERA dosage: 40 MG, UNK. During the same period patient was treated with EQUASYM, RISPERIDONE. Patient recovered.

Strattera Side Effects Report #5288780-7
Physician from GERMANY reported STRATTERA problem on Mar 22, 2007. Male patient, 16 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: blood alkaline phosphatase increased, blood bilirubin increased. STRATTERA dosage: 25 MG, 2/D. During the same period patient was treated with MEDIKINET. Patient recovered.

Strattera Side Effects Report #5288788-1
STRATTERA problem was reported by a Physician from UNITED STATES on Mar 23, 2007. Male patient, child 7 years of age, weighting 44.09 lb, was diagnosed with attention deficit/hyperactivity disorder, sleep disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: aggression, convulsion, prescribed overdose, pyromania, snoring, somnolence. STRATTERA dosage: 2 MG/KG, DAILY (1/D). During the same period patient was treated with ZOLOFT, RISPERDAL, MELATONIN. Patient was hospitalized. Patient recovered.

Strattera Side Effects Report #5290983-2
Physician from NETHERLANDS reported STRATTERA problem on Mar 26, 2007. Male patient, 13 years of age, weighting 78.71 lb, was diagnosed with attention deficit/hyperactivity disorder, sleep disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: arrhythmia, dyspnoea, exercise tolerance decreased, heart rate increased. STRATTERA dosage: 40 MG, UNK. During the same period patient was treated with MELATONIN. Patient recovered.

Strattera Side Effects Report #5291004-8
STRATTERA problem was reported by a Physician from SWEDEN on Mar 26, 2007. Male patient, 14 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: electrocardiogram qt prolonged, loss of consciousness. STRATTERA dosage: 40 MG, DAILY (1/D). Patient was hospitalized. Patient recovered.

Strattera Side Effects Report #5293639-5
Physician from NORWAY reported STRATTERA problem on Mar 28, 2007. Male patient, 15 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: alcohol poisoning, respiratory failure. STRATTERA dosage: unknown. During the same period patient was treated with RITALIN, ETHANOL. Patient was hospitalized. Patient recovered.

Strattera Side Effects Report #5293640-1
STRATTERA problem was reported by a Physician from UNITED STATES on Mar 29, 2007. Male patient, 25 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, gilbert's syndrome, haematuria, hepatocellular damage, hyperbilirubinaemia. STRATTERA dosage: unknown. Patient recovered.

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Drug Information: Atomoxetine

URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a603013.html

(at' oh mox e teen)

IMPORTANT WARNING:

Studies have shown that children and teenagers with attention-deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) who take atomoxetine are more likely to think about killing themselves than children and teenagers with ADHD who do not take atomoxetine.While your child is taking atomoxetine, you should watch his or her behavior very carefully, especially at the beginning of treatment and any time his or her dose is increased or decreased. Your child may develop serious symptoms very suddenly, so it is important to pay attention to his or her behavior every day. Ask other people who spend a lot of time with your child, such as brothers, sisters, and teachers to tell you if they notice changes in your child's behavior. Call your child's doctor right away if your child experiences any of these symptoms: acting more subdued or withdrawn than usual; feeling helpless, hopeless, or worthless; new or worsening depression; thinking or talking about harming or killing him- or herself or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; irritability; aggressive or violent behavior; acting without thinking; extreme increase in activity or talking; frenzied, abnormal excitement; or any other sudden or unusual changes in behavior.Your child's doctor will want to see your child often while he or she is taking atomoxetine, especially at the beginning of his or her treatment. Your child's doctor may also want to speak with you or your child by telephone from time to time. Be sure that your child keeps all appointments for office visits or telephone conversations with his or her doctor.Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with atomoxetine and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/cder) or the manufacturer's website to obtain the Medication Guide.Talk to your doctor about the risks of giving atomoxetine to your child, of using other treatments for your child's condition, and of not treating your child's condition.

Why is this medication prescribed?

Atomoxetine is used as part of a total treatment program to increase the ability to pay attention and decrease impulsiveness and hyperactivity in children and adults with ADHD. Atomoxetine is in a class of medications called selective norepinephrine reuptake inhibitors. It works by increasing the levels of norepinephrine, a natural substance in the brain that is needed to control behavior.

How should this medicine be used?

Atomoxetine comes as a capsule to take by mouth. It is usually taken either once a day in the morning, or twice a day in the morning and late afternoon or early evening. Atomoxetine may be taken with or without food. However, taking atomoxetine with food may help prevent the medication from upsetting your stomach. Take atomoxetine at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take atomoxetine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow atomoxetine capsules whole; do not open, chew, or crush them. If a capsule is accidentally broken or opened, wash away the loose powder with water right away. Try not to touch the powder and be especially careful not to get the powder in your eyes. If you do get powder in your eyes, rinse them with water right away and call your doctor.

Your doctor will probably start you on a low dose of atomoxetine and increase your dose after at least 3 days. Your doctor may increase your dose again after 2-4 weeks.You may notice improvement in your symptoms during the first week of your treatment, but it may take up to one month for you to feel the full benefit of atomoxetine.

Atomoxetine may help control the symptoms of ADHD but will not cure the condition. Continue to take atomoxetine even if you feel well. Do not stop taking atomoxetine without talking to your doctor.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking atomoxetine,

  • tell your doctor and pharmacist if you are allergic to atomoxetine, any other medications, or any of the inactive ingredients in atomoxetine capsules.
  • tell your doctor if you are taking monoamine oxidase (MAO) inhibitors, including isocaraboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking them within the past 2 weeks. Your doctor will probably tell you not to take atomoxetine. If you stop taking atomoxetine, you should wait at least 2 weeks before you start taking an MAO inhibitor.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: albuterol syrup or tablets (Proventil, Ventolin), amiodarone (Cordarone, Pacerone), bupropion (Wellbutrin), chlorpheniramine (antihistamine in cold medications),cimetidine (Tagamet), clomipramine (Anafranil), fluoxetine (Prozac, Sarafem), haloperidol (Haldol), metaproterenol syrup or tablets , medications for high blood pressure, methadone (Dolophine), metoclopramide (Reglan), nefazodone, paroxetine (Paxil), quinidine, ritonavir (Norvir), and sertraline (Zoloft). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had glaucoma (an eye disease that may cause vision loss). Your doctor may tell you not to take atomoxetine.
  • tell your doctor if anyone in your family has or has ever had an irregular heartbeat or has died suddenly. Also tell your doctor if you have recently had a heart attack and if you have or have ever had a heart defect, an irregular heartbeat, heart or blood vessel disease, or other heart problems. Your doctor will probably examine you to see if your heart and blood vessels are healthy. Your doctor may tell you not to take atomoxetine if you have a heart condition or if there is a high risk that you may develop a heart condition.
  • tell your doctor if you or anyone in your family has or has ever had depression or bipolar disorder (manic depressive disorder; a condition that causes episodes of depression, episodes of frenzied, abnormal excitement and other abnormal moods) or has ever thought about or attempted suicide. Also tell your doctor if you have or have ever had high or low blood pressure, seizures, or liver disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking atomoxetine, call your doctor.
  • you should know that atomoxetine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
  • you should know that atomoxetine has caused severe liver damage in some patients. Call your doctor right away if you have any of the following symptoms: itchy skin, dark urine, yellowing of your skin or eyes, pain in the upper right part of your stomach, or flu-like symptoms.
  • you should know that atomoxetine may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
  • you should know that atomoxetine should be used as part of a total treatment program for ADHD, which may include counseling and special education. Make sure to follow all of your doctor's and/or therapist's instructions.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. Do not take more than the prescribed daily amount of atomoxetine in 24 hours.

What side effects can this medication cause?

Atomoxetine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • heartburn
  • nausea
  • vomiting
  • loss of appetite
  • weight loss
  • constipation
  • stomach pain
  • gas
  • dry mouth
  • excessive tiredness
  • dizziness
  • headache
  • mood swings
  • decreased sex drive or ability
  • difficulty urinating
  • painful or irregular menstrual periods
  • muscle pain
  • sweating
  • hot flashes
  • unusual dreams
  • burning or tingling in the hands, arms, feet, or legs

Some side effects can be serious. If you experience any of the following symptoms, or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS section, call your doctor immediately:

  • fast or pounding heartbeat
  • chest pain
  • shortness of breath
  • slow or difficult speech
  • dizziness or faintness
  • weakness or numbness of an arm or leg
  • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
  • hoarseness
  • difficulty swallowing or breathing
  • hives
  • rash
  • abnormal thoughts
  • hallucinating (seeing things or hearing voices that do not exist)
  • erection that lasts for several hours or longer
  • seizures

Atomoxetine may cause sudden death in children and teenagers with heart defects or serious heart problems. This medication also may cause sudden death, heart attack or stroke in adults, especially adults with heart defects or serious heart problems. Talk to your doctor about the risks of taking this medication or of giving this medication to your child.

Atomoxetine may slow down children's growth or weight gain. Your child's doctor will probably monitor your child carefully during his or her treatment with atomoxetine. Talk to your child's doctor about the risks of giving this medication to your child.

Atomoxetine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

  • sleepiness
  • agitation
  • an increase in activity or talking
  • abnormal behavior
  • stomach problems
  • wide pupils (black circles in the middle of the eyes)
  • fast heartbeat
  • dry mouth

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to atomoxetine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand name(s):

  • Strattera®

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