Atomoxetine (Oral route)
There is an increased risk of suicidal ideation in children and adolescents. No suicides occurred in clinical trials. Monitor patients closely for suicidal thinking and behavior, clinical worsening, or unusual changes in behavior .
Central Nervous System Agent
Norepinephrine Reuptake Inhibitor
Uses of This Medicine:
Atomoxetine is used to treat attention-deficit hyperactivity disorder (ADHD) in children, teenagers, and adults. It belongs to the group of medicines called selective norepinephrine reuptake inhibitors.
Atomoxetine works in the brain to increase attention and decrease restlessness in people who are hyperactive, have problems with concentration, or are easily distracted. This medicine may be used as part of a treatment program that includes social, educational, and psychologic treatment.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of atomoxetine in children. However, safety and efficacy have not been established in children younger than 6 years of age.
Appropriate studies on the relationship of age to the effects of atomoxetine have not been performed in the geriatric population. Safety and efficacy have not been established.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bipolar disorder (mood disorder), or family history of or
- Blood vessel problems or
- Depression, or family history of or
- Heart disease (eg, cardiomyopathy) or
- Heart rhythm problems or
- Hypertension (high blood pressure) or
- Hypotension (low blood pressure) or
- Mania or
- Problems with urination or
- Priapism (painful or prolonged erection of the penis) or
- Psychotic disorder (mental illness) or
- Tachycardia (rapid heart rate) Use with caution. May make these conditions worse.
- Liver disease Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Glaucoma, narrow angle or
- Heart disease, severe or
- Pheochromocytoma (an adrenal problem), or history of Should not be used in patients with these conditions.
Proper Use of This Medicine:
Take this medicine only as directed by your doctor. Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
If you or your child think this medicine is not working properly after you have taken it for several weeks, do not increase the dose. Check with your doctor.
This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
Swallow the capsule whole. Do not crush, break, chew, or open it. You may take this medicine with or without food.
Avoid touching a broken or opened capsule. Wash your hands with water right away if you do touch an opened capsule. If this medicine comes in contact with your eyes, rinse them with water and call your doctor right away.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For attention-deficit hyperactivity disorder (ADHD):
- Adults, teenagers, and children 6 years of age and older and weighing over 70 kilograms (kg) At first, 40 milligrams (mg) once a day. The dose is increased after a minimum of 3 days to a total daily dose of 80 mg as a single dose in the morning or divided in 2 doses (morning and late afternoon). Your doctor may adjust your dose as needed. However, the dose is usually not more than 100 mg per day.
- Teenagers and children 6 years of age and older and weighing less than 70 kilograms (kg) Dose is based on body weight and must be determined by your doctor. At first, 0.5 milligram (mg) per kilogram (kg) of body weight once a day. The dose is increased after a minimum of 3 days to a total daily dose of 1.2 mg/kg as a single dose in the morning or divided in 2 doses (morning and late afternoon). Your doctor may adjust your dose as needed. However, the dose is usually not more than 1.4 mg/kg per day.
- Children younger than 6 years of age Use and dose must be determined by your doctor.
- For attention-deficit hyperactivity disorder (ADHD):
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may make you more drowsy, dizzy, less alert, or lightheaded than normal. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. Dizziness, lightheadedness, or fainting may also occur when you get up suddenly from a lying or sitting position. Getting up slowly or lying down for awhile may help.
Do not use this medicine together with a drug for depression called a MAO inhibitor. Some examples of MAO inhibitors are isocarboxazid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®), and tranylcypromine (Parnate®). You should also not use a MAO inhibitor in the 14 days before starting atomoxetine and in the first 14 days after you stop using it.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have itching, hives, hoarseness, shortness of breath, trouble with breathing, trouble with swallowing, or any swelling of your hands, face, or mouth after you take this medicine.
Call your doctor right away if you or your child have more than one of the following symptoms: a skin rash, dark urine, loss of appetite, yellow skin or eyes, flu-like symptoms, or right upper belly pain or tenderness. These could be symptoms of a serious liver problem.
Atomoxetine may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you or your child have chest pain, shortness of breath, or fainting while taking this medicine.
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. These symptoms are more likely to occur when you begin taking this medicine or when the dose is increased. Getting up slowly or lying down for awhile may help.
Tell your doctor right away if you, your child, or a caregiver notices any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behavior. Also tell your doctor if you have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.
This medicine may cause slow growth in children. Your child's doctor will keep track of height and weight.
If you or your child experience a prolonged or painful erection of the penis for more than 4 hours, check with your doctor right away.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects of This Medicine:
- Less common
- Hives or welts
- irregular heartbeat
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- redness of the skin
- skin rash
- Painful, prolonged erection of your penis
- Incidence not known
- dark colored urine
- flu-like symptoms
- loss of bladder control
- muscle spasm or jerking of all extremities
- pelvic pain in male
- right upper belly pain or tenderness
- sudden loss of consciousness
- yellow eyes or skin
- More common
- Acid or sour stomach
- bleeding between periods
- change in amount of bleeding during periods
- change in pattern of monthly periods
- 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)
- dry mouth
- heavy bleeding
- inability to have or keep an erection
- loss in sexual ability, desire, drive, or performance
- pain or tenderness around the eyes and cheekbones
- painful urination
- shortness of breath
- sleepiness or unusual drowsiness
- stomach discomfort, upset, cramps, or pain
- stuffy or runny nose
- tightness of the chest
- trouble sleeping
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- unusual stopping of menstrual bleeding
- unusual tiredness or weakness
- 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
- cold sweats
- cracked, dry, or scaly skin
- decreased weight
- 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
- sinus headache
- sleep disorder
- swelling of the skin
- swollen joints
- swollen, tender prostate
Along with its needed effects, a medicine 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:
Some side effects 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:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 10/12/2016