This article describes possible side effects of Focalin oral forms. To learn more about Focalin, including the drug’s uses, side effects, ways to save on cost, and more, talk with your doctor or pharmacist.
Focalin is a brand-name medication that comes as an oral tablet and an extended-release (XR) oral capsule. (“Extended release” means the drug is slowly released into your body over a long period of time.) It’s available in a generic version called dexmethylphenidate. This article describes possible side effects of Focalin.
Boxed warning: Risk of abuse, misuse, and addiction
Focalin oral forms have a boxed warning for the risk of abuse, misuse, and addiction. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).
For details, see the “Misuse and Focalin” section below.
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More common side effects of Focalin
Focalin oral forms may cause mild or serious side effects. Below are some of the more common side effects of this medication.
Commonly reported side effects of Focalin oral forms include:
- belly pain
- decreased appetite*
- headache
- indigestion
- nausea
- fever
These side effects were reported in studies of Focalin oral tablet and Focalin XR oral capsule.
* To learn more about this side effect, see the “Side effects of Focalin in detail” section below.
Mild side effects of Focalin
Focalin oral forms may cause certain mild side effects. Usually, mild side effects are temporary and can be easily managed. Tell your doctor or pharmacist if you have side effects that don’t go away or become bothersome.
Mild side effects of Focalin oral forms that occurred in studies include:
- anxiety
- belly pain
- decreased appetite*
- dizziness
- dry mouth
- feeling jittery
- fever
- headache
- indigestion
- nausea
- trouble sleeping
- mild allergic reaction*†
* To learn more about this side effect, see the “Side effects of Focalin in detail” section below.
† An allergic reaction is possible with Focalin. But it’s unclear whether it occurred in the drug’s studies of Focalin oral tablet and Focalin XR oral capsule.
These side effects were reported in studies of Focalin oral tablet and Focalin XR oral capsule.
Focalin may cause more mild side effects than those listed above. For details, see the drug’s prescribing information for Focalin oral tablet and Focalin XR oral capsule.
Serious side effects of Focalin
Focalin may cause certain serious side effects. If you have any serious side effects from Focalin oral forms, call your doctor right away. But if you think you’re having a medical emergency or your side effects feel life threatening, take immediate action. Call 911 or a local emergency number, or go to the nearest emergency room.
After the FDA approves a drug, it tracks and reviews side effects of the medication. Visit MedWatch’s website if you’d like to notify the FDA about a side effect you’ve had with Focalin.
Serious side effects of Focalin oral forms that occurred in studies include:
* To learn more about this side effect, see the “Side effects of Focalin in detail” section below.
† Focalin oral tablet and Focalin XR oral capsule have a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the “Misuse and Focalin” section below.
‡ An allergic reaction is possible with Focalin. But it’s unclear whether it occurred in the drug’s studies of Focalin oral tablet and Focalin XR oral capsule.
These side effects were reported in studies of Focalin oral tablet and Focalin XR oral capsule.
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Common questions about side effects of Focalin
Here are answers to some common questions about side effects of Focalin oral forms. If you have other questions, talk with your doctor or pharmacist.
Are side effects of Focalin similar to those seen with Adderall?
Yes, the side effects of Focalin oral forms are similar to those seen with Adderall. Focalin and Adderall are both stimulant drugs. So they have many of the same side effects. These include mild side effects, such as decreased appetite, trouble sleeping, and feeling jittery.
They also have many of the same serious side effects. These include a boxed warning for abuse, misuse, and addiction. A boxed warning is the most serious warning from the FDA. To learn more, see the “Misuse and Focalin” section below.
You can learn more about how these two drugs compare by talking with your doctor or pharmacist.
How long do side effects of Focalin usually last?
It depends. Many of the side effects of Focalin oral forms are mild and temporary. Often, they ease or go away within a few days or weeks. This happens as your body gets used to the drug. But it’s possible for some side effects to continue as long as you take Focalin.
Talk with your doctor or pharmacist to learn more about what to expect with Focalin. If you have side effects that don’t go away or become bothersome, talk with your doctor.
Does Focalin cause long-term side effects?
Yes, in some cases, Focalin oral forms may cause long-term side effects. These can occur if you take the drug for a long time.
Examples of long-term side effects reported with Focalin include:
- slowed growth in children*
- physical dependence (when your body needs a drug in order to function like usual)†
These side effects were reported in studies of Focalin oral tablet and Focalin XR oral capsule.
Talk with your doctor to learn more about these side effects and how to manage them. Ask your doctor for more information about how long these side effects of Focalin may last.
* To learn more about this side effect, see the “Side effects of Focalin in detail” section below.
† Focalin oral tablet and Focalin XR oral capsule have a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the “Misuse and Focalin” section below.
Misuse and Focalin
Focalin oral forms have a boxed warning for the risk of abuse, misuse, and addiction. A boxed warning is the most serious warning from the FDA.
Focalin oral forms have a high risk of misuse. Misuse means a drug is taken in a way other than how it’s prescribed. This can lead to substance use problems, including addiction. Addiction refers to feeling unable to stop using a drug, even though it may be causing harm. This can lead to overdose or death. Misusing Focalin also increases the risk of suicidal thoughts or behaviors.
Taking Focalin for a long time can also lead to physical dependence. Physical dependence means your body needs the drug in order to function like usual. Withdrawal symptoms can occur if you are dependent on a drug and you suddenly stop taking it.
The risk of misuse and addiction may be higher in people who have misused drugs or alcohol in the past.
Talk with your doctor if you have concerns about misuse or addiction with Focalin oral forms. If you experience misuse or addiction, tell your doctor. They can suggest ways to get help. If you have thoughts about hurting yourself, call 911.
Suicide prevention
If you or someone you know is in crisis and considering suicide or self-harm, please seek support:
If you’re calling on behalf of someone else, stay with them until help arrives. You may remove weapons or substances that can cause harm if you can do so safely.
If you are not in the same household, stay on the phone with them until help arrives.
Side effects of Focalin in detail
Below you’ll find details on some of the side effects of Focalin oral forms.
Decreased appetite
In studies, decreased appetite was common in people taking Focalin oral forms. This side effect is usually mild, but it may be serious for some people. This side effect was reported in studies of Focalin oral tablet and Focalin XR oral capsule.
When you take Focalin, you may not feel hungry or want to eat. You may even feel nauseous when you try to eat. This is because stimulant drugs can cause a lack of appetite. For some people, this side effect is temporary and goes away as their body gets used to the medication. For others, it can lead to unhealthy weight loss.
Ways to manage
It can be hard to manage appetite loss with stimulant drugs. But there are a few things you can try. Eat a nutritious meal before you take Focalin in the morning. Then, eat several smaller meals or snacks throughout the day. Follow this in the evening with another nutritious meal.
If your appetite continues to be a problem, tell your doctor. They may be able to suggest other ways to increase the amount of food or calories you eat.
Slowed growth in children
Slowed growth in children is possible with Focalin oral forms. This side effect may be serious. This side effect was reported in the prescribing information for Focalin oral tablet and Focalin XR oral capsule.
Children taking Focalin may have slower-than-expected growth in height and weight. This side effect is common with stimulant drugs, such as Focalin oral forms. In most cases, children will catch up on their growth when doctors have them stop taking the medication.
Ways to manage
Due to this risk, doctors check children’s height and weight often during their treatment with Focalin. They may stop Focalin treatment if a child isn’t growing or gaining weight as expected.
If you have concerns about slowed growth in children, talk with your doctor.
Priapism
Priapism has been reported in people taking Focalin oral forms. This side effect is rare but may be serious. This side effect was reported in the prescribing information for Focalin oral tablet and Focalin XR oral capsule.
Priapism is a painful erection that lasts for 4 hours or longer. This side effect can be seen in both adults and children taking Focalin oral forms. In some cases, it has occurred after dosage increases. Without treatment right away, it can lead to permanent damage.
Ways to manage
If you experience frequent, painful erections, or if you experience an erection lasting 4 hours, get emergency medical care.
For some people, Focalin oral forms can cause an allergic reaction. But it’s not clear whether this side effect occurred in studies of Focalin oral tablet and Focalin XR oral capsule.
Symptoms can be mild or serious, and they may include:
- itchiness
- skin rash
- swelling under the skin, usually affecting eyelids, lips, hands, or feet
- swelling of the mouth, tongue, or throat, which can make it hard to breathe
- flushing (temporary warmth, redness, or deepening of skin color)
Ways to manage
For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.
For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Focalin, your doctor may recommend taking a different medication instead.
Warnings for Focalin
Below are some factors you may want to discuss with your doctor before taking Focalin oral forms.
Boxed warning: Risk of misuse and addiction
Focalin oral forms have a boxed warning for the risk of abuse, misuse, and addiction. A boxed warning is the most serious warning from the FDA.
For details, see the “Misuse and Focalin” section above.
Other warnings
It may not be safe for you to take Focalin oral forms if you have specific health conditions. These are sometimes called drug-condition interactions. Other things may also affect whether Focalin is a safe treatment option for you.
Before taking Focalin oral forms, tell your doctor about your health and medications you take. Things to consider include:
Focalin and pregnancy
It’s not known whether Focalin oral forms should be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication.
Your doctor may talk with you about a pregnancy registry. This registry monitors the outcome of taking Focalin oral forms during pregnancy. It helps scientists learn more about the effects of Focalin during pregnancy. You can learn more or register by visiting the website or calling 866-961-2388.
Focalin and breastfeeding
Focalin oral forms should not be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication. Your doctor may recommend other ways to feed your child during treatment with Focalin.
Focalin oral forms are not known to interact with alcohol.
If you drink alcohol, talk with your doctor about whether it’s safe to consume it during your treatment with Focalin.
What to ask your doctor
This article describes common and serious side effects of Focalin oral forms. If your doctor prescribes this medication, they can discuss possible side effects with you. Let your doctor know if you have concerns or questions about treatment with this medication.
Here’s a list of some possible questions you may want to ask your doctor:
- Does my risk of side effects depend on the dosage I take?
- How do the side effects of Focalin oral forms compare with other drugs that could treat my condition?
- Do any of my other medications increase the risk of side effects with Focalin oral forms?
Disclaimer: Optum Perks has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
