Xcopri is a brand-name oral tablet that’s prescribed for partial-onset seizures. Xcopri contains the active ingredient cenobamate.
Drug details
You’ll find key information about Xcopri below.
- Drug class: antiepileptic drug (AED), also known as an anticonvulsant
- Drug form: oral tablet
- Generic available? no
- Prescription required? yes
- Controlled substance? yes
- Year of FDA approval: 2020
Xcopri is available only as a brand-name medication. It’s not currently available in generic form.
A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.
Xcopri can cause mild or serious side effects in some people. The following lists contain some of the key side effects that may occur while taking Xcopri. These lists do not include all possible side effects.
For more information about the possible side effects of Xcopri, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you would like to notify the FDA about a side effect you’ve had with Xcopri, you can do so through MedWatch.
Mild side effects
Mild side effects* of Xcopri can include:
- weight loss
- mild drowsiness
- dizziness†
- fatigue
- headache
- digestive problems, such as nausea, constipation, diarrhea, or vomiting
Most of these side effects may go away within a few days to a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.
* This is a partial list of mild side effects from Xcopri. To learn about other mild side effects, talk with your doctor or pharmacist, or view Xcopri’s prescribing information.
† For more information about this side effect, see “Side effect details” below.
Serious side effects
Serious side effects from Xcopri aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.
Serious side effects and their symptoms can include:
- Problems with coordination. Symptoms can include:
- vertigo or balance problems
- trouble walking or changes in the way you walk
- Cognitive (brain-related) problems, such as:
- confusion
- trouble remembering things or paying attention
- difficulty thinking and speaking
- Vision changes. Symptoms can include:
- nystagmus (a condition that causes eye movement you can’t control)
- blurred or double vision
- changes in how well you can see
- Serious allergic reaction, including drug reaction with eosinophilia and systemic symptoms (DRESS).*
- Severe drowsiness.*
- Atypical heart rhythm.*
- Suicidal thoughts or behavior.*
* For more information about this side effect, see “Side effect details” below.
Side effect details
Here are some details on certain side effects this drug may cause.
Note: In addition to the information above and below, you can also refer to this in-depth article about Xcopri’s side effects.
Allergic reactionAs with most drugs, some people can have an allergic reaction after taking Xcopri. Allergic reactions while taking Xcopri were rare in clinical studies of the drug.
Symptoms of a mild allergic reaction can include:
A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:
- swelling under your skin, typically in your eyelids, lips, hands, or feet
- swelling of your tongue, mouth, or throat
- trouble breathing
DRESS reaction explained
Xcopri can also cause a rare but possibly life threatening allergic reaction called drug reaction with eosinophilia and systemic symptoms (DRESS). This reaction can affect your blood cells, skin, and internal organs, such as your liver, kidneys, or heart.
DRESS is a serious side effect of seizure drugs, including Xcopri. DRESS symptoms can vary but may include:
- swollen lymph nodes
- facial swelling
- skin rash
- dark urine
- fever
- trouble breathing
- leg swelling
- jaundice (yellowing of the skin or the whites of your eyes)
When to seek help
Call your doctor right away if you have an allergic reaction to Xcopri, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.
Drowsiness
Feeling drowsy was one of the most common side effects of Xcopri in clinical studies of this drug. For most people, this side effect is usually mild and temporary.
Symptoms can include:
- fatigue
- feeling tired after getting plenty of sleep
- feeling too weak or sluggish to do your usual activities
Severe drowsiness is a less common side effect of Xcopri. In clinical studies, this side effect caused some people to stop taking the drug. To find out how often drowsiness occurred in clinical studies, see the drug’s prescribing information.
Because of the risk of drowsiness, you should not drive or operate machinery when you first start taking Xcopri. Alcohol and other drugs that cause sleepiness can further increase your risk of severe drowsiness with Xcopri. Before starting Xcopri treatment, be sure to tell your doctor about any other medications that you currently take.
You should also talk with your doctor if you have drowsiness that doesn’t go away or becomes severe. They may adjust your dosage or recommend a different medication.
Atypical heart rhythm
Xcopri can cause an atypical heart rhythm called QT shortening. This condition occurs when a specific pattern in your heart’s usual rhythm becomes shorter. Symptoms may include:
- heart palpitations, which may feel like your heart is fluttering
- fast heartbeat
- losing consciousness or fainting
In clinical studies, QT shortening wasn’t common. Heart palpitations were also not common, and were reported only in people taking 400 milligrams (mg) of Xcopri per day. This is the maximum dosage of Xcopri. To find out how often QT shortening occurred in clinical studies, see the drug’s prescribing information.
Because of the possibility of QT shortening, the manufacturer of Xcopri recommends against using the drug if you have a condition called familial short QT syndrome. To learn more, see the “Xcopri precautions” section below.
If you develop heart palpitations or other side effects that concern you, talk with your doctor right away. They may test your heart for QT shortening. If you have QT shortening, they’ll typically have you stop taking Xcopri and recommend other treatment options.
Suicidal thoughts or behavior
In rare cases, taking Xcopri may increase the risk of having suicidal thoughts or behavior. This side effect is a risk with all anti-epileptic drugs (the group of drugs that Xcopri belongs to). To find out how often this side effect occurred in clinical studies, see the drug’s prescribing information.
Symptoms of suicidal thoughts or behavior may include:
- thoughts about harming yourself
- prolonged sadness and loss of interest in favorite activities
- anxiety or panic attacks
- other unusual changes in mood or behavior
After starting Xcopri treatment, pay attention to any sudden changes in the way you think or act. Your doctor will also monitor you closely for any changes.
If you experience any suicidal thoughts or behaviors or mood changes while taking Xcopri, seek help immediately. Talk with your doctor right away or go to a hospital for emergency medical care.
Suicide prevention
If you know someone at immediate risk of self-harm, suicide, or hurting another person:
- Ask the tough question: “Are you considering suicide?”
- Listen to the person without judgment.
- Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
- Stay with the person until professional help arrives.
- Try to remove any weapons, medications, or other potentially harmful objects.
If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.
As with all medications, the cost of Xcopri can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.
Drug coupons: You can visit Optum Perks for price estimates of Xcopri. These estimates are based on the use of Optum Perks coupons. Note: Optum Perks coupons cannot be used with any insurance copays or benefits.
Financial and insurance assistance: If you need financial support to pay for Xcopri, or if you need help understanding your insurance coverage, help is available.
A trial offer and a program called SK Life Science Navigator are available for Xcopri. For more information and to find out if you’re eligible for support, call 866-756-2844 or visit the program website.
Generic version: Xcopri is not available in a generic form. A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics tend to cost less than brand-name drugs.
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Here are answers to some frequently asked questions about Xcopri.
Are there any reviews available from people who’ve used Xcopri?
Before trying something new, it’s common to look for written reviews about the experiences of others. You may be able to find testimonials online from people who take Xcopri.
But reviews and complaints about medications, including Xcopri, may not be as reliable as other types of consumer reviews. This is because every person’s body responds differently to medications. You can’t reliably predict how your body will react to a treatment based on someone else’s experience.
To help you decide whether Xcopri is a good treatment choice for you, talk with your doctor or pharmacist. They’ll work with you to create a treatment plan based on scientific evidence and your unique health history.
Are there coupons available to help me pay for Xcopri?
Xcopri’s manufacturer offers a free trial coupon. You can download it and give it to your pharmacist. To use this coupon, you’ll also need a prescription for Xcopri from your doctor.
For potential ways to save money during continued treatment with the drug, see the “Xcopri cost” section above for available resources.
Can Xcopri make me feel ‘high’?
Possibly. A euphoric mood (feeling “high”) was a less common side effect in clinical studies of Xcopri. This side effect occurred only in people who took 400 milligrams (mg) of Xcopri per day. This is the maximum dosage of Xcopri.
According to the studies, taking more than your prescribed dose of Xcopri can make you feel high or “drunk.” Because of this risk, Xcopri is classified as a Schedule V prescription drug, which is a controlled substance. The government regulates controlled substances such as Xcopri because they can lead to dependence and misuse.*
It’s important to take only the dose of Xcopri that your doctor prescribes for you. Taking more than this may raise your risk for serious side effects, such as excessive drowsiness.
If you have questions about these risks, talk with your doctor before starting treatment with Xcopri.
* Dependence refers to needing a drug to feel like usual. Misuse refers to taking a drug in a way other than how it’s prescribed. See “Xcopri withdrawal and dependence” below for details.
The mechanism of action of how Xcopri treats partial-onset seizures (also called focal seizures) isn’t fully understood. (“Mechanism of action” refers to how a drug works.)
Xcopri reduces the frequency of certain signals in the brain that keep repeating. This seems to help prevent the brain from becoming too stimulated. As a result, Xcopri can reduce the frequency of seizures.
How long does it take to work?
It may take several weeks to months for Xcopri to start working. Typically, your doctor will start by prescribing a low dosage. Then they’ll slowly increase your dosage over 12 weeks. Because of this gradual increase, it may take a while for Xcopri to build up in your system and reach its full effect.
In clinical trials, some people who took Xcopri experienced significantly fewer partial-onset seizures per month over the 12-week study. This was in comparison with how many partial-onset seizures they usually had per month before they started taking the drug.
How long does Xcopri stay in your system?
Xcopri can stay in your system for 10–13 days after your last dose.
Xcopri has a half-life of 50–60 hours. (The half-life of a drug is the amount of time it takes for your body to remove half a dose of Xcopri from your system.) It typically takes about five half-lives for a drug to be completely removed from your system.
The Xcopri dosage your doctor prescribes will depend on several factors. These include:
- the severity of the condition you’re taking Xcopri to treat
- other medical conditions you may have
- your age
Typically, your doctor will start by prescribing a low dosage. Then they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.
Drug forms and strengths
Xcopri comes as an oral tablet in six strengths: 12.5 milligrams (mg), 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg.
Dosage for partial-onset seizures
The following information describes dosages of Xcopri that are commonly recommended for partial-onset seizures.
Starting Xcopri treatment
When you start taking Xcopri, you’ll receive the medication in starter packages. The first starter package contains 12.5 mg and 25 mg tablets. Your doctor will typically have you follow the starter dosing schedule (also called a titration schedule) for Xcopri:
| Week | Dosage once per day |
|---|---|
| 1 and 2 | 12.5 mg |
| 3 and 4 | 25 mg |
| 5 and 6 | 50 mg |
| 7 and 8 | 100 mg |
| 9 and 10 | 150 mg |
| 11 and on | 200 mg |
After you take 200 mg of Xcopri per day for at least 2 weeks, your doctor may continue to increase your dosage over time. This depends on how Xcopri affects you and how well it works for you. Your dosage shouldn’t be increased by more than 50 mg every 2 weeks.
Xcopri maintenance dosage
Once you and your doctor find the Xcopri dosage that helps you manage your seizures, you’ll likely take it long term. This is called a maintenance dosage. The recommended maintenance dosage of Xcopri is 200 mg per day.
For most people, the maximum dosage of Xcopri is 400 mg per day.
Your doctor may prescribe a lower maximum dose if you have certain liver problems. A lower dose may also be used if you have certain kidney problems or if you’re age 65 years or older.
What if I miss a dose?
It’s important not to miss doses of Xcopri. If you miss a dose, talk with your doctor right away. They’ll give you instructions on what your next steps should be.
To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.
Will I need to use this drug long term?
Xcopri is meant to be used as a long-term treatment. If you and your doctor determine that Xcopri is safe and effective for you, you’ll likely take it long term.
Note: For more details about Xcopri’s dosage, you can refer to this in-depth article.
Can I suddenly stop taking Xcopri?
No, you should not suddenly stop taking Xcopri. It’s important not to stop taking Xcopri unless your doctor specifically instructs you to do so.
Suddenly stopping seizure medications, such as Xcopri, can increase your risk of having more seizures. It may also lead to status epilepticus, which is a seizure that lasts longer than 5 minutes. Status epilepticus may be life threatening.
If your doctor decides you’ll stop Xcopri treatment, they’ll gradually decrease your dose before you completely stop taking it.
The Food and Drug Administration (FDA) approves prescription drugs such as Xcopri to treat certain conditions.
Xcopri for partial-onset seizures
Xcopri is FDA-approved to treat partial-onset seizures (also called focal seizures) in adults.
Xcopri belongs to a group of drugs called anti-epileptic drugs (AEDs), also known as anticonvulsants. Xcopri may be prescribed by itself or in combination with other drugs, such as other AEDs. These medications are used to manage, treat, or help prevent seizures in people with epilepsy (a brain condition that causes recurring seizures).
About partial-onset seizures
With partial-onset seizures, an irregular surge of electrical activity occurs in one area of the brain. Symptoms may occur before, during, and after a seizure and usually affect one side of the body.
Seizure symptoms can vary, but may include:
- uncontrolled movements
- muscle twitching or stiffness
- staring blankly
- repetitive movements, such as rapid blinking, lip-smacking, or skin-picking
Partial-onset seizures can last for seconds to 2 minutes. During this type of seizure, you may be aware of what’s happening, or you may lose consciousness (pass out). Afterward, you may feel confused, tired, and you may not remember what happened.
You can refer to our epilepsy and seizure hub for details about this condition.
Effectiveness for partial-onset seizures
Xcopri is an effective treatment for reducing the number of partial-onset seizures in adults.
In clinical trials, some people who took Xcopri experienced significantly fewer partial-onset seizures per month. This was in comparison with how many partial-onset seizures they usually had per month before they started taking the drug.
For more information about Xcopri’s clinical trial results, see the manufacturer’s website or the drug’s prescribing information.
Xcopri and children
Xcopri is FDA-approved to treat partial-onset seizures in adults. It’s not known whether Xcopri is safe or effective for children.
Xcopri can interact with several other medications.
Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.
Xcopri and other medications
Below is a list of medications that can interact with Xcopri. This list does not contain all drugs that may interact with Xcopri.
Before taking Xcopri, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.
If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
Types of drugs that can interact with Xcopri include:
- Hormonal birth control medications: Taking Xcopri with birth control medications that contain hormones (such as forms of estrogen) can make the birth control less effective. Examples of these drugs include:
- birth control pills
- etonogestrel/ethinyl estradiol vaginal ring (NuvaRing, EluRyng)
- levonorgestrel (Plan B One-Step)
- norelgestromin/ethinyl estradiol transdermal patch (Ortho Evra, Xulane, Zafemy)
- Other central nervous system depressants: Taking other central nervous system (CNS) depressants with Xcopri may increase your risk for side effects.* Some examples include:
- opioids, such as codeine, oxycodone (OxyContin), and tramadol (Ultram)
- benzodiazepines, such as clonazepam (Klonopin) and diazepam (Valium)
- sedatives (“sleeping pills”), such as zolpidem (Ambien and Ambien CR) or suvorexant (Belsomra)
- alcohol
- Certain drugs that affect heart rhythm: Xcopri can cause QT shortening (a specific pattern when your heart’s usual rhythm becomes shorter). The manufacturer of Xcopri recommends against taking Xcopri with drugs that can also cause QT shortening. An example of this drug is rufinamide (Banzel).
Taking Xcopri in combination with other types of drugs, including certain other seizure medications, may affect how well the medications work. If your doctor also prescribes one or more of these medications for you along with Xcopri, they may adjust the dosage of each of your drugs.
Some examples of drugs that may be affected by Xcopri include:
- carbamazepine (Tegretol)
- clobazam (Onfi)
- lamotrigine (Lamictal)
- phenytoin (Dilantin)
* To learn more about side effects, see the “Xcopri side effects” section above.
Xcopri and herbs and supplements
There aren’t any herbs or supplements that have been specifically reported to interact with Xcopri. However, you should still check with your doctor or pharmacist before using any of these products while taking Xcopri.
Xcopri and foods
There aren’t any foods that have been specifically reported to interact with Xcopri.
You can take Xcopri with or without food.
If you have any questions about eating certain foods with Xcopri, talk with your doctor.
Drinking alcohol while you’re taking Xcopri is not recommended. Doing so can your risk of certain side effects, such as:
- excessive drowsiness
- dizziness
- trouble with coordination and walking
If you drink alcohol, talk with your doctor before you start taking Xcopri.
You should take Xcopri according to the instructions your doctor or another healthcare professional gives you.
Xcopri comes as an oral tablet that you swallow with a liquid, such as water.
You’ll take your prescribed dose of Xcopri once daily. You may take your dose with or without food.
Your doctor may prescribe a dose of Xcopri that requires you to take more than one tablet. For example, if your dosage is 400 milligrams (mg) per day, you’ll likely take two 200-mg tablets once daily. In such situations, you should swallow both tablets at once (or one right after the other). You should not space them apart throughout the day.
When to take
You should take Xcopri once daily. You can take your dose at any time of day but try to take it at the same time every day. This keeps a consistent level of the drug in your body so it can work effectively.
To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.
Taking Xcopri with food
You can take Xcopri with or without food.
Can Xcopri be crushed, split, or chewed?
No, you should not crush, split, or chew Xcopri tablets. They should be swallowed whole with water or another liquid. If you have trouble swallowing pills, talk with your doctor or pharmacist. They may offer advice on how to swallow pills or recommend a different treatment option.
It’s unknown whether Xcopri is safe to take during pregnancy. The drug’s clinical trials didn’t include people who were pregnant. However, in studies of pregnant animals, Xcopri caused harmful effects in fetuses.
If you’re pregnant or planning to become pregnant, talk with your doctor. They can guide you on the safest treatment options for you.
Pregnancy registry
If you become pregnant while taking Xcopri, talk with your doctor about signing up with the North American Antiepileptic Drug Pregnancy Registry. This registry collects information about the safety of certain seizure medications during pregnancy. This information can then help you make informed decisions about the treatments you take during pregnancy.
Learn more by calling 888-233-2334 or visiting the program website.
It’s not known whether Xcopri is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while taking Xcopri.
For more information about taking Xcopri during pregnancy, see the “Xcopri and pregnancy” section above.
Note: Sex and gender exist on spectrums. Use of the terms “female” and “male” in this article refers to sex assigned at birth.
For females taking Xcopri
If you’re a female who takes birth control, Xcopri may interact with hormonal birth control, such as birth control pills. If you use hormonal birth control, your doctor may suggest switching to a nonhormonal treatment.
Some examples of nonhormonal birth control include condoms, spermicides, and a copper intrauterine device (IUD). In some cases, your doctor may recommend using condoms in addition to your hormonal birth control.
For males taking Xcopri
There are no specific birth control recommendations for males taking Xcopri. If you are sexually active with a partner who can become pregnant, talk with your doctor about your birth control options while taking Xcopri.
It’s not known whether Xcopri is safe to take while breastfeeding. The effects of Xcopri on human breast milk or children who are breastfed haven’t been studied.
If you’re breastfeeding or planning to breastfeed, talk with your doctor. They may suggest other treatment options. Or if your condition is severe, they may recommend other ways to feed your child so that you can take Xcopri.
Before taking Xcopri, talk with your doctor about your health history. Xcopri may not be right for you if you have certain medical conditions or other factors affecting your health. These include:
- Short QT syndrome: If you have a heart condition called short QT syndrome, your doctor won’t prescribe Xcopri. This is because the drug can affect the heart’s rhythm. Specifically, it can shorten a part of the rhythm called the QT interval. If you have short QT syndrome or familial short QT syndrome (a type of genetic condition that causes heart rhythm problems), your doctor will prescribe a different treatment for you.
- Liver or kidney problems: If you have liver or kidney problems, talk with your doctor before starting Xcopri treatment. They may check the health of these organs using blood tests. If your doctor finds that your liver or kidney problems are severe, they’ll likely prescribe a different medication for you. But if your problems aren’t severe, they may prescribe a lower dosage of Xcopri than usual. They’ll also monitor your liver or kidneys during treatment.
- Depression: If you have depression, talk with your doctor before taking Xcopri. It’s possible that this drug could worsen your condition. Very rarely, taking Xcopri may raise the risk of suicidal thoughts or behavior. Your doctor will monitor you closely after you start taking Xcopri, especially as they increase your dosage during your first few months of treatment. If you notice any unusual changes in your mood, thoughts, or behavior, talk with your doctor right away.
- Allergic reaction: If you’ve had an allergic reaction to Xcopri or any of its ingredients, you should not take Xcopri. Ask your doctor about other medications that may be better options for you.
- Pregnancy: It’s unknown whether Xcopri is safe to take during pregnancy. For more information, see the “Xcopri and pregnancy” section above.
- Breastfeeding: It’s not known whether Xcopri is safe to take while breastfeeding. For more information, see the “Xcopri and breastfeeding” section above.
Note: For more information about the potential negative effects of Xcopri, see the “Xcopri side effects” section above.
Do not take more Xcopri than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.
What to do in case you take too much Xcopri
If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.
Xcopri can cause drug dependence (needing the drug to feel like you usually do).
Because of this risk, Xcopri is classified as a Schedule V prescription drug, which is a controlled substance. The government regulates controlled substances such as Xcopri because they can lead to dependence and misuse. Misuse refers to taking a drug in a way other than how it’s prescribed.
According to clinical studies, stopping Xcopri may cause withdrawal symptoms. These are effects that can occur after you stop taking a drug you’re dependent on. Withdrawal symptoms may include:
- insomnia (trouble sleeping)
- reduced appetite
- depressed mood
- tremors
- memory problems
If your doctor recommends that you stop taking Xcopri, they’ll gradually decrease your dose for at least 2 weeks before you stop taking the drug completely.
When you get Xcopri from the pharmacy, the pharmacist will add an expiration date to the label on the bottle or packaging. This date is typically 1 year from the date they dispensed the medication.
The expiration date helps guarantee that the medication is effective during this time. The
Storage
How long a medication remains good to use can depend on many factors, including how and where you store the medication.
Xcopri tablets should be stored at room temperature, 68–77°F (20–25°C), in their original package. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.
Disposal
If you no longer need to take Xcopri and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.
This article provides several useful tips on medication disposal. You can also ask your pharmacist for information about how to dispose of your medication.
Disclaimer: Medical News Today 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.
