Ergotamine-Caffeine

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Warning

This medication has rarely caused a serious lack of blood flow to the arms/hands, or to the feet, or to the brain, which could cause a stroke. The risk is increased when this medication is taken with other drugs that can affect the removal of ergotamine from your body. Examples include mifepristone, telithromycin, certain antidepressants (such as nefazodone), azole antifungals (such as ketoconazole, itraconazole), cobicistat, macrolide antibiotics (such as clarithromycin, erythromycin, troleandomycin), HIV protease inhibitors (such as nelfinavir, indinavir), ritonavir, SSRIs (such as fluoxetine, paroxetine, fluvoxamine), among others.

Precautions

Before taking this medication, tell your doctor or pharmacist if you are allergic to ergotamine or caffeine; or to other ergot alkaloids (such as dihydroergotamine); or if you have any other allergies. This product may contain inactive ingredients (such as tartrazine found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (for example, in your legs, arms/hands, or stomach), certain types of headaches (hemiplegic or basilar migraine), heart problems (such as chest pain, irregular heartbeat, previous heart attack), kidney disease, liver disease, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), stroke or "mini-stroke" (transient ischemic attack).

Certain conditions can increase your risk for heart problems. Tell your doctor if you have any of these conditions, including: high blood pressure, high cholesterol, diabetes, family history of heart disease, overweight, postmenopausal (women), age more than 40 years (men).

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Remember that alcohol may cause headaches.

Using tobacco/nicotine products while using this medication can increase the risk of serious side effects such as heart problems and decreased blood flow to the brain/hands/feet. Do not use tobacco while taking this medication. If you smoke, talk to your doctor about how to stop smoking.

Before having surgery or certain medical procedures (such as a heart stress test or a procedure to restore a normal heart rhythm if you have an unusually fast heartbeat), tell your doctor or dentist that you use this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.

This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Side Effects

Nausea, vomiting, upset stomach, restlessness, trouble sleeping, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: slow/fast/irregular heartbeat, numbness/tingling in fingers/toes, blue fingers/toes/nails, cold hands/feet, muscle pain/weakness, severe stomach/abdominal pain, lower back pain, signs of kidney problems (such as change in the amount of urine).

Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, confusion, trouble speaking, vision changes, weakness on one side of the body.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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Drug information is selected from data included with permission and copyrighted by First DataBank, Inc. This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional. Always seek the advice of your healthcare professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your healthcare professional. This information does not contain any assurances that this product is safe, effective or appropriate for you.

This information is intended only for residents of the United States. Products sold under the same brand names in other countries may contain different ingredients.

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Information expires December 2025.