*An off-label use of a medication is a use that is not FDA-approved. Prescribers can decide to use a medication off-label because, in their professional judgment, they believe it may offer a benefit to someone.
Cobenfy is a newly FDA-approved medication to treat schizophrenia in adults. The medication has a few rare but serious side effects related to the bladder, digestive tract, and heart that patients should be aware of. Cobenfy can also cause less serious side effects such as nausea, dizziness, constipation, sleepiness, and gastrointestinal reflux. Take time to understand Cobenfy’s risks before use to ensure a safe and effective treatment with the drug.
Key takeaways
Cobenfy is a new FDA-approved antipsychotic medication to treat schizophrenia in adults and is a type of antipsychotic medication called a muscarinic agonist. It is not approved for use for children or teens under the age of 18.
Cobenfy has a lower risk of side effects than standard schizophrenia treatments, but it is not without risks.
Cobenfy alternatives may be necessary for some to consider, including typical and atypical antipsychotics.
If you are considering an alternative to Cobenfy, a good place to start is with an evaluation from a medical provider. Lifestance Health is a reliable online psychiatry platform offering online assessments and medication management.
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What Is Cobenfy & How Is it Used?
Cobenfy is a newly FDA-approved medication to treat schizophrenia in adults and is a type of antipsychotic medication called a muscarinic agonist. FDA approval means that the FDA has determined the drug to be safe and effective when used as intended by the manufacturer based on submitted studies. Cobenfy is not intended to be used by children or adolescents under 18 years old. The usual administration of Cobenfy is one capsule twice daily 1 hour before or 2 hours after a meal.
Cobenfy is a combination of two medications called xanomeline and trospium chloride that affect receptors in the body called muscarinic receptors.1 The two medications work together to reduce all types of schizophrenia symptoms. They also carry a lower risk of side effects than the usual antipsychotic treatments for schizophrenia.2 In clinical trials, patients taking Cobenfy showed a significant lessening in all symptoms of schizophrenia.1
How Does Cobenfy Make You Feel?
Cobenfy should start working within a few days to a few weeks. Your prescriber will most likely increase your dose slowly over time. Only change your dose at the direction of your provider.1
Cobenfy will cause symptoms of schizophrenia to lessen over time. For example, using Cobenfy may lead to a reduction in delusional thinking, hostility, social or emotional withdrawal, disorientation, anxiety, or depression.3 Some side effects may impact your alertness, such as dizziness. Others may be related to your digestive tract, such as nausea, constipation, or diarrhea.1
Your prescriber will help track the improvement of schizophrenic symptoms. It is important to keep scheduled meetings with your prescriber and to follow your prescription exactly. Keep notes of how you feel each day, whether better or worse, to provide detailed and accurate information for your prescriber.
Common Side Effects of Cobenfy
Common side effects from Cobenfy can be mild to severe. Being aware of your risk can help you identify and treat them accordingly if they occur. Cobenfy is unique since it contains two medications that work in different ways. Side effects can vary widely from constipation to diarrhea or fainting from low blood pressure to high blood pressure and a fast heartbeat.1
While most common side effects will be mild, some can be severe and require medical attention. If side effects do not go away or become worse you or your caretaker should seek medical help. If you have severe pain, faint, or have a very fast heart beat also seek medical attention.1
Common side effects of Cobenfy include:1*
- Nausea
- Indigestion
- Constipation
- Vomiting
- Hypertension (high blood pressure)
- Abdominal pain
- Diarrhea
- Elevated heart rate
- Dizziness
- GERD (gastroesophageal reflux disease)
- Dry mouth
- Drowsiness
*All medications, including Cobenfy, can cause side effects which can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your doctor about any questions you have and to understand the potential side effects and benefits of any medication.
Serious Side Effects of Cobenfy
Taking Cobenfy can put a patient at risk for serious side effects. If you experience any of the following side effects you should emergency medical care right away. These side effects can happen when first starting Cobenfy or weeks to months after starting treatment. Be sure to look for signs of something wrong and seek help early. Many severe side effects are related to the body slowing down such as central nervous depression, slowing of the digestive tract, or urinary retention.1
Serious side effects of Cobenfy include:*1
- Urinary retention, including weak stream, incomplete emptying, or painful urination
- Serious liver injury
- Acute biliary disease
- Slowed movement within the digestive tract
- Swelling of the face, lips, tongue and/or larynx
- Increased heart rate
- Severe central nervous depression such as confusion, dizziness, hallucinations, drowsiness
*All medications, including Cobenfy, can cause side effects which can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your doctor about any questions you have and to understand the potential side effects and benefits of any medication.
Cobenfy Long-Term Side Effects
There are numerous warnings to be aware of if taking Cobenfy long term. While Cobenfy is a newly approved medication, it contains medications that have been around and used for some time. Serious long term side effects can occur and each patient should be aware of these before starting treatment. This includes cardiovascular, gastrointestinal, and neurological side effects, which have been observed during shorter-term use.
If your doctor determines you are at an increased risk for any of these long term side effects, additional monitoring may be required. Your doctor will conduct tests before treatment with Cobenfy and then frequently monitor you throughout treatment to detect signs of serious long term side effects. Your doctor may recommend you not take Cobenfy at all if your risk for long term side effects is too high.1
Resources For Schizophrenia
Treatment for Schizophrenia, Covered by Insurance – Grow Therapy enables you to find a psychiatrist or psychiatric nurse practitioner who can diagnose your condition, prescribe appropriate medications, and monitor your reaction to medication. Find A Provider
Schizophrenia Newsletter – Free newsletter from Choosing Therapy for those impacted by Schizophrenia. Get encouragement, tips, and latest info sent twice per week. Sign Up
What Are the Risks & Warnings for Cobenfy?
Confusion or Hallucinations
Some patients, particularly older adults or those with certain medical conditions, may experience confusion, dizziness, or even hallucinations while taking Cobenfy. Caution is advised when performing tasks that require alertness, such as driving.
Problems Emptying Bladder Completely
Cobenfy may cause difficulty emptying the bladder completely (urinary retention), especially in older adults or those with bladder issues such as an enlarged prostate. Patients should watch for symptoms like trouble starting to urinate or a weak stream.
Liver Damage
Cobenfy can increase the risk of liver injury, particularly in those with liver problems. Regular monitoring of liver enzymes is required, and symptoms such as yellowing skin or dark urine should be reported immediately.
Bile Duct Blockage
Some patients may experience problems with bile flow, leading to gallstones and pancreatitis. Symptoms like upper abdominal pain, nausea, or vomiting should prompt medical attention.
Slowed Digestion
Cobenfy may reduce the movement of food through the stomach, especially in patients with pre-existing gastrointestinal issues such as colitis or myasthenia gravis. Watch for signs of stomach pain or constipation.
Angioedema (Severe Swelling)
Swelling of the face, lips, tongue, or throat has been reported and may require emergency care.
Increased Heart Rate
Cobenfy may raise heart rates, especially in patients with pre-existing heart conditions. Monitoring heart rate during treatment is recommended.
Narrow-angle Glaucoma Risk
Cobenfy can trigger or worsen glaucoma in those with anatomically narrow angles. Patients with this eye condition should use the medical only under close supervision.
Central Nervous Side Effects
Cobenfy can cause side effects that affect the central nervous system (CNS), also called anticholinergic CNS side effects. These include dizziness, confusion, hallucinations, and drowsiness. Those with kidney problems may experience stronger anticholinergic side effects like dry mouth, constipation, or trouble urinating. The medication is not recommended for individuals with moderate to severe kidney impairment.
There may be additional warnings or precautions with this medication. Talk with your healthcare provider about all the risks before you start taking this medication.
Allergic Reactions to Cobenfy
Allergic reactions to medications can be serious and life threatening. Allergic reactions can be mild or severe and life threatening. The important thing to do is seek emergency medical help right away if you suspect an allergic reaction.
If you have any allergic reactions in the past to trospium chloride you should not take Cobenfy. Trospium chloride is part of Cobenfy and taking Cobenfy could lead to another allergic reaction.
Allergic reactions to Cobenfy include:1
- Itching
- Hives
- Trouble breathing
- Swelling of the face, mouth, lips and throat
If any of these symptoms appear or you suspect an allergic reaction call 911 right away. A serious allergic reaction can cause difficulty breathing and if left untreated, death. Quick emergency medical help is crucial to reducing harm and preventing death.
Interactions That May Worsen Cobenfy Side Effects
Many drugs can interact with Cobenfy, negatively affecting your treatment or causing worse side effects. It is important to alert your prescriber of all the medications you are taking at the same time as Cobenfy. This can help your prescriber determine your correct dose, or alert you of important interactions.
If you start a new medication while on Cobenfy, be sure to let your provider know.1 Additionally, Cobenfy can affect the way that other drugs work in your body. It is also important to tell any other providers you have that you are taking Cobenfy, since other medication doses may need to be altered.
In general, drugs that have similar risks of side effects can cause worse side effects than usual. An example would be a medication, or alcohol, that causes central nervous depression. This type of medication taken with Cobenfy can cause dangerous and severe CNS depression. A great resource is your local pharmacist. They can help to review all your current medications and determine any dangerous side effects that may occur with Cobenfy.
Disclaimer: This is not a comprehensive list of the possible interactions with Cobenfy. You should talk with your healthcare provider and your pharmacist about all prescription and over-the-counter medications, herbs, and supplements you take before starting Cobenfy.
How to Manage Cobenfy Side Effects
Many common side effects from taking Cobenfy can be managed by you or your doctor, keeping you safe and comfortable during treatment. Not everyone will experience the same side effects while taking Cobenfy. Talk with your prescriber before starting Cobenfy to understand what side effects you may be most at risk for. Having a side effect management plan before you begin treatment can help you act quickly if side effects do occur.
It is important to remember that moderate or severe side effects should be treated by a medical professional. If you are unsure whether a side effect you are experiencing is severe, seek immediate health care or call 911.
Nausea or Vomiting
A common side effect of Cobenfy is nausea or severe nausea leading to vomiting. This risk can be worsened by the need for Cobenfy to be taken on an empty stomach. If nausea is limiting your ability to eat meals, try taking Cobenfy two hours after meals rather than 1 hour before meals. If you feel the nausea is limiting you throughout the day, talk with your prescriber about additional medications that can be prescribed to reduce nausea symptoms.
Indigestion or Abdominal pain
Cobenfy can slow down the activity of the digestive tract, leading to abdominal pain or indigestion. You may need to adjust the size of your meals, the timing or your meals, or the contents of your meals to reduce discomfort. Alternatively, your doctor may alter your dose if the discomfort does not go away. Work with your doctor to find the right times during the day to take your Cobenfy. The goal is to take your Cobenfy doses 12 hours apart.1
Constipation or Diarrhea
Taking Cobenfy can change the way the digestive tract works, leading to constipation or diarrhea. Both conditions can be dangerous if not dealt with promptly. If diarrhea occurs, rehydrate well with electrolytes if needed. Monitor how often you have a loose stool and consult your prescriber if you should take antidiarrheal medication.
If constipation is the issue, be sure to drink plenty of water and incorporate fiber into your diet. If constipation does not improve consider taking a stool softener or consult your doctor about taking a laxative. Addressing constipation or diarrhea promptly with your prescriber is important to keep you healthy during treatment with Cobenfy.1
Dizziness or Drowsiness
Cobenfy can cause drowsiness and dizziness that can become dangerous if not managed accordingly. Do not drive or operate heavy machinery when starting Cobenfy. Cobenfy affects people differently and the level of drowsiness can vary. Talk to your doctor if you feel you are too drowsy to be alert during the day as your dose may be too high. Do not try to combat drowsiness with other medications or substances like caffeine because this combination could be dangerous.
Lifestyle Tips to Reduce Cobenfy Side Effects
Starting a new medication regimen can be stressful, especially when the new treatment brings about additional unwanted side effects. Having a routine in place for taking your medications, eating a well balanced diet and exercising, can help reduce some of the side effects from Cobenfy.
Avoid food that may upset your stomach and lead to worse digestive side effects. Maintain a sufficient sleep schedule, as not enough sleep could worsen Cobenfy related drowsiness. While these lifestyle tips will not eliminate side effects from Cobenfy, they can help reduce their severity. 4
When to Seek an Alternative to Cobenfy Due to Side Effects
Initial side effects of Cobenfy typically subside after a few weeks. If after some time you are looking to change your medication due to continued side effects, work with a doctor to find an alternative.
LifeStance Health is a reliable online provider that offers Cobenfy alternatives available. Both typical and atypical antipsychotic can help reduce symptoms of psychosis, and some are more suitable for certain conditions than others. The potential risks and benefits of each medication varies.
Other atypical antipsychotics are usually the first medications considered as Cobenfy alternatives because of their safety and effectiveness. These medications are newer and offer fewer side effects and less frequent dosing schedules. Still, they require close monitoring throughout therapy.
Typical antipsychotic medications are also known as first-generation antipsychotics. These medications usually come with a risk of more severe side effects that need to be monitored. Additionally, typical antipsychotics often need to be taken multiple times per day.
How to Get a Prescription for Cobenfy or an Alternative
If you are looking to start Cobenfy, or are considering an alternative due to side effects, start by speaking with a prescriber. To get a prescription for Cobenfy or an alternative in person, start with an evaluation for your symptoms. Your primary care provider, who may be a physician, nurse practitioner, or physician assistant, can help you get the process started. They may make a referral to a psychiatrist or specialist to determine if a prescription Cobenfy alternatives should be included in your treatment plan.
To get an online prescription for Cobenfy or an alternative, you will also start by getting evaluated by an online psychiatry platform. We have thoroughly reviewed platforms like Lifestance Health that prescribe antipsychotic medications.
Schizophrenia Treatment, Covered by Insurance
Grow Therapy enables you to find a psychiatrist or psychiatric nurse practitioner who can diagnose your condition, prescribe appropriate medications, and monitor your reaction to medication. Find A Provider
Questions to Ask Your Provider
It is important to discuss the potential side effects of Cobenfy, psychiatrist, or therapist you may experience immediately after starting the treatment. Ask them whether these side effects will go away on their own or if any intervention is needed.
Also, many online psychiatry services are available with convenient access to mental health care. Individuals may even change prescribers and get a mental health evaluation, diagnosis, and personalized treatment plan.
Questions to ask your care team about Cobenfy side effects:
- How long will it take for me to adjust to taking Cobenfy?
- Will my dosage change over time?
- Am I at risk for more serious symptoms if I am already taking other medications?
- What is the best dosage to ensure fewer side effects?
- How should I take Cobenfy? Multiple times each day? With or without food?
- I have to drive for my job, will Cobenfy affect my ability to drive?
- What can I do if I experience common side effects that won’t go away?
- How do I know that Cobenfy is working?
- Can I drink alcohol or use cannabis products while taking Cobenfy?
- What are signs of serious side effects?
Prescriber’s Tips
Your prescriber will share important information about your Cobenfy prescription. They will explain how to take and store your medication, what to avoid when taking it, and what to do about side effects. Follow these tips for safe and effective use of Cobenfy.
- Keep routine appointments with your prescriber for the safest and most effective treatment possible. Your prescriber will likely start you on a lower dose and increase it over time while monitoring you for side effects.
- Tell your provider about side effects right away. Use management strategies recommended by your provider, or reach out to your care team. Side effects may not necessarily go away on their own.
- Cobenfy works best taken on an empty stomach. Taking the medication with food can lessen the medication’s effect and may cause an upset stomach. Do your best to take Cobenfy at least 1 hour before or 2 hours after a meal.
- Keep track of how often you use the bathroom while on Cobenfy. Rare but serious side effects include urinary retention and slowing of the digestive tract. It is important to identify changes in bathroom use promptly and seek medical care.
Frequently Asked Questions
Is Cobenfy Safe for Older Adults?
Cobenfy is most likely not safe for older adults. Studies have not included geriatric patients. In addition, geriatric patients often have decreased function of kidneys and the liver, which can increase the risk for dangerous side effects. Additionally, older male patients are already at a higher risk for urinary retention. If you are older than 65 and are interested in taking Cobenfy, talk with your prescriber about whether it may be a fit for you.1
Can Cobenfy Be Used During Pregnancy or While Breastfeeding?
It is not yet known how Cobenfy will affect the pregnant parent or fetus during pregnancy or breastfeeding. Considering any medication treatment, including Cobenfy, while pregnant should be a conversation between you and your provider that weighs the risks and benefits. Studies have shown that both components of Cobenfy are present in breast milk.1
Is Cobenfy an Antipsychotic?
Cobenfy is not considered an antipsychotic medication. While it is used to treat schizophrenia, it is a combination of two medications that work on muscarinic receptors throughout the body.1
Is Cobenfy Safer Than Other Medications for Schizophrenia?
Cobenfy is a new and unique medication to treat schizophrenia. Antipsychotics are the usual treatments for schizophrenia, and these medications come with a risk for developing tardive dyskinesia. This is a serious chronic condition that causes involuntary, repetitive movements in the body. Although Cobenfy is also an antipsychotic, it works differently in the body and seems to have less of a risk for developing these involuntary movements.5
Is it Safe to Drive While Taking Cobenfy?
Cobenfy can cause drowsiness that would make it dangerous to drive. However, after understanding how Cobenfy affects your alertness, it may be safe to drive. Work with your doctor to make an informed decision.1
Choosing Therapy strives to provide our readers with mental health content that is accurate and actionable. We have high standards for what can be cited within our articles. Acceptable sources include government agencies, universities and colleges, scholarly journals, industry and professional associations, and other high-integrity sources of mental health journalism. Learn more by reviewing our full editorial policy.
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Bristol Myers Squibb. (September, 2024). Cobenfy U.S. Prescribing Information. Retrieved from: https://packageinserts.bms.com/pi/pi_cobenfy.pdf
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Foster, D. J., Bryant, Z. K., & Conn, P. J. (May 21, 2021). Targeting muscarinic receptors to treat schizophrenia. Behavioural brain research, 405, 113201. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8006961/
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A Systematic Review of Combination and High-Dose Atypical Antipsychotic Therapy in Patients with Schizophrenia. (December, 2011). Canadian Agency for Drugs and Technologies in Health; VALIDITY OF PSYCHIATRIC SYMPTOM SCALES AND CLINICAL IMPLICATIONS. Retrieved from: https://www.ncbi.nlm.nih.gov/books/NBK169692/
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Living with – Schizophrenia. (September 13, 2021). NHS, Mental Health Conditions. Retrieved from: https://www.nhs.uk/mental-health/conditions/schizophrenia/living-with/
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Cornett, E. M., Novitch, M., Kaye, A. D., Kata, V., & Kaye, A. M. (2017). Medication-Induced Tardive Dyskinesia: A Review and Update. Ochsner journal, 17(2), 162–174. Retrieved from: https://pmc.ncbi.nlm.nih.gov/articles/PMC5472076/
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