Indomethacin

• In rare cases, nonsteroidal anti-inflammatory drugs like Indomethacin may increase the risk of heart attack or stroke. This can occur at any time while taking this drug but is more likely if you take it for a long time.
• The risk of heart attack or stroke may be greater in older adults who have heart disease or increased risk for heart disease — for example, due to smoking, family history of heart disease or conditions such as high blood pressure or diabetes. Do not take this drug right before or after heart bypass surgery (CABG).
• In rare cases, Indomethacin may cause serious (rarely fatal) bleeding from the stomach or intestines, which can occur without warning symptoms at any time while taking it. Older adults may be at higher risk for this effect (see also “Precautions to be aware of” and “Drug interactions” sections).

• Stop taking Indomethacin and get medical help right away if you notice any of the following rare but serious side effects:

  • Stomach or abdominal pain that doesn't go away
  • Bloody or black/tarry stools
  • Vomit that looks like coffee grounds
  • Chest, jaw or left arm pain
  • Shortness of breath
  • Unusual sweating
  • Weakness on one side of the body
  • Sudden vision changes
  • Trouble speaking

• Talk with your medical provider or pharmacist about the risks and benefits of using this medication.

• This medication is used to relieve pain, swelling and joint stiffness caused by arthritis, gout, bursitis and tendonitis. It is also used to relieve pain from various other conditions.
• Indomethacin belongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). It works by blocking your body's production of certain natural substances that cause inflammation, helping to decrease swelling and pain.
• If you are treating a chronic condition such as arthritis, ask your medical provider about non-drug treatments and/or using other medications to treat your pain (see also “Warnings to be aware of” section).

• Read the Medication Guide provided by your pharmacist before you start using Indomethacin and each time you get a refill. If you have any questions, ask your medical provider or pharmacist.
• Take this medication by mouth as directed by your medical provider, usually 2 to 3 times a day with a full glass of water (8 ounces or 240 milliliters). Do not lie down for at least 10 minutes after taking this drug. If stomach upset occurs while taking this medication, take it with food, milk or an antacid.
• The dosage is based on your medical condition and response to treatment. In children, the dosage is also based on weight. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or use this drug more often or for longer than prescribed. For ongoing conditions such as arthritis, continue taking this medication as directed. Discuss the risks and benefits with your medical provider or pharmacist.
• With certain conditions (such as arthritis), it may take up to 4 weeks when Indomethacin is taken regularly before you notice the full benefits.
• If you are taking this drug on an "as needed" basis (not on a regular schedule), remember that pain medications work best if they are used when the first signs of pain occur. If you wait until the pain worsens, the medication may not work as well.
• Tell your medical provider if your condition worsens.

• Upset stomach, heartburn, headache, drowsiness or dizziness may occur. If any of these effects last or get worse, tell your medical provider or pharmacist right away.
• Remember that this medication has been prescribed because your medical provider has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not experience serious side effects.
• This medication may raise your blood pressure. Check your blood pressure regularly and tell your medical provider if the results are high.

• Tell your medical provider right away if you experience any serious side effects, including:

  • Hearing changes, such as ringing in the ears
  • Mental or mood changes such as confusion or hallucinations
  • Difficult or painful swallowing
  • Symptoms of heart failure, such as swelling ankles or feet, unusual tiredness or unusual/sudden weight gain
• Get medical help right away if you experience any very serious side effects, including signs of kidney problems, such as change in the amount of urine or unexplained stiff neck.

• In rare cases, this drug may cause serious (possibly fatal) liver disease. Get medical help right away if you experience any symptoms of liver damage, including:

  • Nausea or vomiting that doesn't stop
  • Loss of appetite
  • Dark urine
  • Severe stomach or abdominal pain
  • Yellowing eyes or skin

• 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:

  • Fever
  • Swollen lymph nodes
  • Rash
  • Itching or 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, request a callback for medical advice. You may also report side effects to the FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

• Before taking Indomethacin, tell your medical provider or pharmacist if you are allergic to it, Aspirin or other NSAIDs (such as Ibuprofen, Naproxen or Celecoxib) or have any other allergies. Go to your patient dashboard and request a callback for more details.
• This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

• Before using this medication, tell your medical provider or pharmacist your medical history, especially of:

  • Asthma, including a history of worsening breathing after taking Aspirin or other NSAIDs
  • Bariatric surgery
  • Bleeding or clotting problems
  • Depression
  • Epilepsy
  • Growths in the nose (nasal polyps)
  • Heart disease, including a previous heart attack
  • High blood pressure
  • Liver disease
  • Lupus or other connective tissue disorders
  • Parkinson's disease
  • Stomach, intestinal or esophagus problems, such as bleeding/ulcers/recurring heartburn
  • Stroke
• Kidney problems may occur with the use of NSAID medications, including Indomethacin. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult or take certain medications (see also “Drug interactions” section). To prevent dehydration, drink plenty of fluids as directed by your medical provider. Tell them right away if you experience a change in amount of urine. This medication can also increase potassium levels, which can be fatal, especially in setting of kidney disease.
• This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can exacerbate the effect. Do not drive, use machinery or do anything that requires alertness until you can do it safely. Talk to your medical provider if you are using marijuana.
• This medicine may cause stomach bleeding. Daily use of alcohol and tobacco – especially when combined with this medication – may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your medical provider or pharmacist for more information.
• Before having surgery, tell your doctor or dentist about all the products you use, including prescription drugs, nonprescription drugs and herbal products.
• This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your medical provider right away if you get sunburned or have skin blisters/redness.
• Older adults may be at greater risk for stomach or intestinal bleeding, kidney problems, heart attack, stroke and mental/mood changes while using this drug.
• Children may be more sensitive to the side effects of this drug, especially serious liver problems. Caution is advised when this drug is used by children. Discuss the risks and benefits of treatment with your medical provider.
• Before using this medication, women of childbearing age should talk with their medical provider(s) about the benefits and risks. Tell your medical provider if you are pregnant or if you plan to become pregnant. This medication may harm an unborn baby and cause problems with normal labor/delivery. It is not recommended for use in pregnancy from 20 weeks until delivery. If your medical provider decides that you need to use this medication between 20 and 30 weeks of pregnancy, you should use the lowest effective dose for the shortest possible time. You should not use this medication after 30 weeks of pregnancy.
• This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your medical provider before breastfeeding.

• Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions.
• Keep a list of all the products you use – including prescription/nonprescription drugs and herbal products – and share it with your medical provider and pharmacist.
• Do not start, stop or change the dosage of any medicines without your medical provider's approval.

• Some products that may interact with this drug include:

  • Aliskiren
  • ACE inhibitors, such as Captopril and Lisinopril
  • Angiotensin II receptor blockers, such as Valsartan and Losartan
  • Cidofovir
  • Corticosteroids, such as Prednisone
  • Digoxin
  • Haloperidol (Haldol)
  • Lithium
  • Methotrexate
  • Selective serotonin reuptake inhibitors (SSRIs), such as Citalopram, Fluoxetine and Sertraline
  • "Water pills," or diuretics, such as Furosemide
• This medication may increase the risk of bleeding when taken with other drugs that can also cause bleeding. Examples include anti-platelet drugs, such as Clopidogrel, and "blood thinners," such as Dabigatran, Enoxaparin and Warfarin, among others.
• Check all prescription and nonprescription medicine labels carefully, as many medications contain pain relievers/fever reducers (including Aspirin and NSAIDs, such as Celecoxib, Diflunisal, Ibuprofen or Ketorolac). These drugs are similar to Indomethacin and may increase your risk of side effects if taken together. However, if your medical provider has directed you to take low-dose Aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should continue taking it unless they instruct you otherwise. Ask your medical provider or pharmacist for more details.
• This medication can affect the results of certain lab tests. Make sure laboratory personnel and your medical providers know you use this drug.

• Symptoms of overdose may include:

  • Severe stomach pain
  • Vomit that looks like coffee grounds
  • Extreme drowsiness
  • Slow or shallow breathing
  • Confusion
  • Seizures
• If someone has overdosed and is experiencing serious symptoms – such as passing out or trouble breathing – call 911.
• If symptoms from taking this medication are less severe, call your local poison control center at 1-800-222-1222 right away.

• Do not share this medication with others.
• Lab and/or medical tests – such as blood pressure, complete blood count and liver/kidney function – may be performed while you are taking this medication. Keep all medical and lab appointments. Consult your medical provider for more details.
• Non-drug treatment for arthritis that is approved by your medical provider – such as weight loss if needed or strengthening and conditioning exercises – may help improve your flexibility, range of motion and joint function. Consult your medical provider for specific instructions.

If you are prescribed this drug on a regular schedule (not just "as needed") and you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

• Store at room temperature away from light and moisture. Do not store in the bathroom.
• Keep all medications away from children and pets.
• Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details.