Tetrahydrocannabinol and Cannabidiol

This information from Lexicomp^® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.

Brand Names: Canada

Sativex

What is this drug used for?

• It is used to treat pain or muscle stiffness in patients with MS (multiple sclerosis).
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take this drug?

• If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you or a family member have ever had schizophrenia or any other mental or mood problem.
• If you have liver disease.
• If you plan to father a child while you are being treated.
• If you are able to get pregnant and are not using birth control.
• If you are pregnant or may be pregnant. Do not take this drug if you are pregnant.
• If you are breast-feeding. Do not breast-feed while you take this drug.
• If the patient is a child. Do not give this drug to a child.

This is not a list of all drugs or health problems that interact with this drug.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take this drug?

• Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
• Do not use more than what your doctor told you to use. Do not use more often or longer than what you were told. Doing any of these things may raise the chance of very bad side effects.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Use care to prevent injury and avoid falls or crashes.
• Avoid grapefruit and grapefruit juice.
• Do not smoke or use other forms of cannabis (marijuana) while taking this drug. Talk with your doctor.
• This drug has alcohol in it. Talk with the doctor.
• This drug may catch on fire. Do not use near an open flame or while smoking.
• If you are 65 or older, use this drug with care. You could have more side effects.
• Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking this drug.
• This drug may cause harm to the unborn baby if you take it while you are pregnant.
• If you or your sex partner may become pregnant, you must use birth control while taking this drug and for some time after the last dose. Ask your doctor how long to use birth control. If you or your sex partner gets pregnant, call your doctor right away.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• A fast heartbeat.
• Seizures.
• Trouble passing urine.
• Not able to focus.
• Change in balance.
• Slurred speech.
• Blurred eyesight.
• Appetite changes.
• Trouble speaking.
• Anxiety.
• Hallucinations (seeing or hearing things that are not there).
• This drug may cause dizziness, memory problems, mood or behavior changes, strong urges that are hard to control, confusion, or losing contact with reality. People have also passed out when taking this drug. Some of these effects may get better if the dose is lowered or the doctor changes how often you take this drug. Call your doctor right away if you have any of these effects, mood changes, or thoughts of suicide.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where this drug was used.
• Feeling dizzy, sleepy, tired, or weak.
• Constipation, diarrhea, stomach pain, upset stomach, or throwing up.
• Dry mouth.
• Change in taste.
• Change in color of mouth and teeth.
• Cough.
• Throat irritation.
• Feeling sluggish, drunk, or out of sorts.
• Feeling high (easy laughing and feeling good).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to your national health agency.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

How is this drug best taken?

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Shake gently before use.
• Prime pump before first use by spraying it 2 to 3 times into a tissue until you see a fine mist.
• Spray into mouth below the tongue or on the inside of the cheeks.
• Space each spray by at least 15 minutes.
• Put the cap back on after you are done using your dose.
• Move the site in your mouth with each spray.
• Do not spray into nose.
• Do not spray the back of the throat.
• Do not spray onto sore or swollen areas in the mouth.
• Keep the spray away from the eyes. If this drug gets in the eyes, rinse right away with water. If eye irritation or redness lasts, call the doctor.

What do I do if I miss a dose?

• If you use this drug on a regular basis, use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.
• Many times this drug is used on an as needed basis. Do not use more often than told by the doctor.

How do I store and/or throw out this drug?

• Store unopened vials in a refrigerator. Do not freeze.
• Store upright with the cap on.
• After opening, store at room temperature.
• Throw away any part not used 6 weeks after opening.
• Protect from heat and sunlight.
• Store this drug in a safe place where children cannot see or reach it, and where other people cannot get to it. A locked box or area may help keep this drug safe. Keep all drugs away from pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

General drug facts

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else’s drugs.
• Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This generalized information is a limited summary of diagnosis, treatment, and/or medication information. It is not meant to be comprehensive and should be used as a tool to help the user understand and/or assess potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a specific patient. It is not intended to be medical advice or a substitute for the medical advice, diagnosis, or treatment of a health care provider based on the health care provider’s examination and assessment of a patient’s specific and unique circumstances. Patients must speak with a health care provider for complete information about their health, medical questions, and treatment options, including any risks or benefits regarding use of medications. This information does not endorse any treatments or medications as safe, effective, or approved for treating a specific patient. UpToDate, Inc. and its affiliates disclaim any warranty or liability relating to this information or the use thereof. The use of this information is governed by the Terms of Use, available at https://www.wolterskluwer.com/en/know/clinical-effectiveness-terms.

Last Reviewed Date

2022-03-14

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