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Precautions While Using This Drug

If you experience abdominal or stomach pain, dark urine, loss of appetite, nausea or vomiting, unusual tiredness or weakness, or yellow eyes or skin, check with your physician immediately . These may be symptoms of liver problems.

It is very important that your physician check your progress at regular visits to make sure that this drug is working properly and to check for unwanted effects

It is very important to follow carefully any instructions from your health care team about

• Alcohol–Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
• Other drugs–Do not take other drugs during the time you are taking avandia unless they have been discussed with your physician. This especially includes nonprescription drugs such as aspirin, and drugs for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling–Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, diabetic patients may need special counseling about diabetes drug dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
• Travel–Keep a recent prescription and your medicinal history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
• In case of emergency –There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medicinal identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your drugs.
• This drug does not cause hypoglycemia (low blood sugar). However, low blood sugar can occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting.
• Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.
• If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, nondiet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family also should know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic drug, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination should include the (frequency and amount); ketones in urine; loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your physician for instructions

Side Effects of This Drug

Along with its needed effects, a drug may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medicinal attention.

Check with your physician as soon as possible if any of the following side effects occur

More common

Fever, runny or stuffy nose; swelling of feet or lower legs

Other side effects may occur that usually do not need medicinal attention. These side effects may go away during treatment as your body adjusts to the drug. However, check with your physician if any of the following side effects continue or are bothersome:

More common

Back pain; headache

Less common

Dizziness or lightheadedness

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your physician.

Proper Use of This Drug

Follow carefully the special meal plan your physician gave you . This is the most important part of controlling your condition, and is necessary if the drug is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Avandia may be taken with or without food .

Dosing–The dose of avandia will be different for different patients. Follow your physician’s orders or the directions on the label . If your dose is different, do not change it unless your physician tells you to do so.

• For oral dosage form (tablets):
  • For type 2 diabetes:
    • Avandia alone:
      • Adults–At first, the dose is 4 milligrams (mg) once a day or 2 mg twice a day. After 12 weeks, the dose may be increased to 8 mg once a day or 4 mg twice a day
      • Children: Use and dose must be determined by your physician.
    • Avandia with metformin:
      • Adults–At first, the dose is 4 mg once a day or 2 mg twice a day. After 12 weeks, the dose may be increased to 8 mg once a day or 4 mg twice a day.
      • Children: Use and dose must be determined by your physician.
    • Avandia with a sulfonylurea:
      • Adults–4 mg once a day or 2 mg twice a day. Any changes in the dose will be determined by your physician.
      • Children: Use and dose must be determined by your physician.

Missed dose–If you miss a dose of this drug, take it as soon as you remember. However, if you do not remember it until it is time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage–To store this drug:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not keep outdated drug or drug no longer needed. Ask your health care professional how you should dispose of any drug you do not use. Be sure that any discarded drug is out of the reach of children.

Proper Use of This Drug

Follow carefully the special meal plan your physician gave you . This is the most important part of controlling your condition, and is necessary if the drug is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Avandia may be taken with or without food .

Dosing–The dose of avandia will be different for different patients. Follow your physician’s orders or the directions on the label . If your dose is different, do not change it unless your physician tells you to do so.

• For oral dosage form (tablets):
  • For type 2 diabetes:
    • Avandia alone:
      • Adults–At first, the dose is 4 milligrams (mg) once a day or 2 mg twice a day. After 12 weeks, the dose may be increased to 8 mg once a day or 4 mg twice a day
      • Children: Use and dose must be determined by your physician.
    • Avandia with metformin:
      • Adults–At first, the dose is 4 mg once a day or 2 mg twice a day. After 12 weeks, the dose may be increased to 8 mg once a day or 4 mg twice a day.
      • Children: Use and dose must be determined by your physician.
    • Avandia with a sulfonylurea:
      • Adults–4 mg once a day or 2 mg twice a day. Any changes in the dose will be determined by your physician.
      • Children: Use and dose must be determined by your physician.

Missed dose–If you miss a dose of this drug, take it as soon as you remember. However, if you do not remember it until it is time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage–To store this drug:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not keep outdated drug or drug no longer needed. Ask your health care professional how you should dispose of any drug you do not use. Be sure that any discarded drug is out of the reach of children.

Brand Names

Some commonly used brand names are:

• Avandia
• Rosiglitazone

Category

• Antidiabetic agent

Description

Avandia is used to treat a certain type of diabetes mellitus (sugar diabetes) called type 2 diabetes. It may be used alone or with another type of oral diabetes drug, such as metformin or a sulfonylurea.

This drug is available only with your physician’s prescription, in the following dosage form:

Oral

• Tablets (U.S. and Canada)

Before Using This Drug

In deciding to use a drug, the risks of taking the drug must be weighed against the good it will do. This is a decision you and your physician will make. For avandia, the following should be considered:

Allergies–Tell your physician if you have ever had any unusual or allergic reaction to avandia. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy–Avandia has not been studied in pregnant women. However, it is easier during pregnancy to control your blood sugar by using injections of insulin, rather than by taking avandia. Close control of your blood sugar can reduce the chance of your baby gaining too much weight, having birth defects, or having high blood sugar before birth. Be sure to tell your physician if you plan to become pregnant or you think you are pregnant.

Breast-feeding–It is not known whether avandia passes into the breast milk of humans. However, avandia is not recommended during breast-feeding.

Children–Studies on this drug have been done only in adult patients, and there is no specific information comparing use of avandia in children with use in other age groups.

Older adults–This drug has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicinal problems–The presence of other medicinal problems may affect the use of avandia. Make sure you tell your physician if you have any other medicinal problems, especially:

• Diabetic ketoacidosis (ketones in the blood) or

• Type 1 diabetes-Insulin is needed to control these conditions
• Heart disease or

• Liver disease-Avandia may make these conditions worse

Precautions While Using This Drug

It is important that your physician check your progress at regular visits to make sure that this drug is working properly and to check for unwanted effects.

Check with your physician immediately if you think that you may be pregnant . Avapro may cause birth defects or other problems in the baby if taken during pregnancy.

Do not take other drugs unless they have been discussed with your physician. This especially includes over-the-counter (nonprescription) drugs for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

Dizziness or lightheadedness may occur, especially if you have been taking a diuretic (water pill). Make sure you know how you react to this drug before you drive, use machines, or do anything else that could be dangerous if you experience these effects .

Check with your physician right away if you become sick while taking this drug, especially with severe or continuing nausea and vomiting or diarrhea. These conditions may cause you to lose too much water and lead to low blood pressure.

Dizziness, lightheadedness, or fainting may also occur if you exercise or if the weather is hot. Heavy sweating can cause loss of too much water and result in low blood pressure. Use extra care during exercise or hot weather.

Side Effects of This Drug

Along with its needed effects, a drug may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medicinal attention.

Other side effects may occur that usually do not need medicinal attention. These side effects may go away during treatment as your body adjusts to the drug. However, check with your physician if any of the following side effects continue or are bothersome:

Less common

Anxiety and/or nervousness; cold-like symptoms; belching, heartburn, and stomach discomfort; cold symptoms; diarrhea; headache; muscle or bone pain; unusual tiredness

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your physician.

Other medicinal problems–The presence of other medicinal problems may affect the use of avapro. Make sure you tell your physician if you have any other medicinal problems, especially:

• Congestive heart failure, severe–Lowering of blood pressure by avapro may make this condition worse

• Dehydration–Blood pressure-lowering effects of avapro may be increased.

• Kidney disease–Effects of avapro may be increased because of slower removal of drug from the body.

Proper Use of This Drug

Take this drug only as directed by your physician . Do not take more of it and do not take it more often than your physician ordered. This drug works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at the same time each day .

Dosing–The dose of avapro will be different for different patients. Follow your physician’s orders or the directions on the label . The following information includes only the average doses of avapro. If your dose is different, do not change it unless your physician tells you to do so.

The number of tablets that you take depends on the strength of the drug.

• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults–75 or 150 milligrams (mg) once a day. Your physician may increase your dose if needed.
    • Children–Use and dose must be determined by your physician.

Missed dose–If you miss a dose of this drug, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage–To store this drug:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the drug to break down.
• Do not keep outdated drug or drug no longer needed. Be sure that any discarded drug is out of the reach of children.

Brand Names

• Avapro
• Irbesartan

Category

• Antihypertensive

Description

Avapro belongs to the class of drugs called angiotensin II inhibitor antihypertensives. It is used to treat high blood pressure (hypertension).

High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure also may increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Avapro works by blocking the action of a substance in the body that causes blood vessels to tighten. As a result, avapro relaxes blood vessels. This lowers blood pressure.

This drug is available only with your physician’s prescription, in the following dosage form(s):

Oral

• Tablets (U.S.)

Before Using This Drug

In deciding to use a drug, the risks of taking the drug must be weighed against the good it will do. This is a decision you and your physician will make. For avapro, the following should be considered:

Allergies–Tell your physician if you have ever had any unusual or allergic reaction to avapro. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy–Use of avapro during pregnancy, especially during the second and third trimesters (after the first 3 months), can cause low blood pressure, severe kidney failure, or even death in the newborn. Therefore, it is important that you check with your physician immediately if you think that you may have become pregnant . Be sure that you have discussed this with your physician before taking this drug.

Breast-feeding–It is not known whether avapro passes into breast milk. However, avapro passes into the milk of lactating rats. Because this drug may cause serious side effects, breast-feeding is generally not recommended while you are taking it.

Children–Studies on this drug have been done only in adult patients, and there is no specific information comparing use of avapro in children with use in other age groups.

Older adults–This drug has been tested in patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, blood levels of avapro may be increased in the elderly and elderly patients may be more sensitive to the effects of avapro.

Other drugs–Although certain drugs should not be used together at all, in other cases two different drugs may be used together even if an interaction might occur. In these cases, your physician may want to change the dose, or other precautions may be necessary. When you are taking avapro, it is especially important that your health care professional know if you are taking any of the following:

• Diuretics (water pills)–Effects on blood pressure may be increased

Precautions While Using This Drug

It is very important that your physician check your progress at regular visits . This drug may cause blood problems, especially if it is taken for a long time.

If your symptoms (including diarrhea) do not improve within 1 or 2 months, or if they become worse, check with your physician.

Sulfasalazine may cause blood problems. These problems may result in a greater chance of certain infections, slow healing, and bleeding of the gums. Therefore, you should be careful when using regular toothbrushes, dental floss, and toothpicks. Dental work should be delayed until your blood counts have returned to normal. Check with your medicinal physician or dentist if you have any questions about proper oral hygiene (mouth care) during treatment.

Sulfasalazine may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this drug:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your physician .

This drug may also cause some people to become dizzy. Make sure you know how you react to this drug before you drive, use machines, or do anything else that could be dangerous if you are dizzy . If this reaction is especially bothersome, check with your physician.

Before you have any medicinal tests, tell the physician in charge that you are taking this drug. The results of the bentiromide (e.g., Chymex) test for pancreas function are affected by this drug.

Side Effects of This Drug

Along with its needed effects, a drug may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medicinal attention.

Check with your physician immediately if any of the following side effects occur:

More common

Aching of joints; headache (continuing); itching; skin rash

Less common or rare

Aching of joints and muscles; back, leg, or stomach pains; bloody diarrhea; bluish fingernails, lips, or skin; chest pain; cough; difficult breathing; difficulty in swallowing; fever, chills, or sore throat; general feeling of discomfort or illness; loss of appetite; pale skin; redness, blistering, peeling, or loosening of skin; unusual bleeding or bruising; unusual tiredness or weakness; yellow eyes or skin

Also, check with your physician as soon as possible if the following side effect occurs:

More common

Increased sensitivity of skin to sunlight

Other side effects may occur that usually do not need medicinal attention. These side effects may go away during treatment as your body adjusts to the drug. However, check with your physician if any of the following side effects continue or are bothersome:

More common

Abdominal or stomach pain or upset; diarrhea; loss of appetite; nausea or vomiting

In some patients this drug may also cause the urine or skin to become orange-yellow. This side effect does not need medicinal attention.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your physician.

Additional Information

Once a drug has been approved for marketing for a certain use, experience may show that it is also useful for other medicinal problems. Although these uses are not included in product labeling, sulfasalazine is used in certain patients with the following medicinal conditions:

• Ankylosing spondylitis

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Proper Use of This Drug

Do not give sulfasalazine to infants and children up to 2 years of age , unless otherwise directed by your physician. It may cause brain problems.

Sulfasalazine is best taken right after meals or with food to lessen stomach upset. If stomach upset continues or is bothersome, check with your physician.

Each dose of sulfasalazine should also be taken with a full glass (8 ounces) of water. Several additional glasses of water should be taken every day , unless otherwise directed by your physician. Drinking extra water will help to prevent some unwanted effects of the sulfa drug.

For patients taking the enteric-coated tablet form of this drug:

• Swallow tablets whole. Do not break or crush.

Keep taking this drug for the full time of treatment , even if you begin to feel better after a few days. Do not miss any doses .

Dosing–The dose of sulfasalazine will be different for different patients. Follow your physician’s orders or the directions on the label . The following information includes only the average doses of sulfasalazine. If your dose is different, do not change it unless your physician tells you to do so.

The number of tablets that you take depends on the strength of the drug. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the drug depend on the medicinal problem for which you are taking sulfasalazine .

• For prevention or treatment of inflammatory bowel disease:
  • For oral dosage forms (tablets, enteric-coated tablets):
    • Adults and teenagers–To start, 500 milligrams (mg) to 1000 mg (1 gram) every six to eight hours. Your physician may then decrease the dose to 500 mg every six hours. Later, your physician may change your dose as needed.
    • Children 2 years of age and over–Dose is based on body weight and must be determined by your physician.
      • To start, the dose is usually:
        • 6.7 to 10 mg per kilogram (kg) (3.05 to 4.55 mg per pound) of body weight every four hours or
        • 10 to 15 mg per kg (4.55 to 6.82 mg per pound) of body weight every six hours or
        • 13.3 to 20 mg per kg (6.05 to 9.09 mg per pound) of body weight every eight hours.
      • Then, the dose is usually 7.5 mg per kg (3.41 mg per pound) of body weight every six hours.
    • Infants and children up to 2 years of age–Use is not recommended.
• For treatment of rheumatoid arthritis:
  • For oral dosage forms (tablets, enteric-coated tablets):
    • Adults and teenagers–To start, 500 mg to 1000 mg (1 gram) daily. Your physician may increase your dose as needed, but the dose is generally not more than 3000 mg (3 grams) a day.
    • Children 2 years of age and over–Dose must be determined by your physician.
    • Infants and children up to 2 years of age–Use is not recommended.

Missed dose–If you do miss a dose of this drug, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage–To store this drug:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the tablet form of this drug in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the drug to break down.
• Keep the enema form of this drug from freezing.
• Do not keep outdated drug or drug no longer needed. Be sure that any discarded drug is out of the reach of children.

Other drugs–Although certain drugs should not be used together at all, in other cases two different drugs may be used together even if an interaction might occur. In these cases, your physician may want to change the dose, or other precautions may be necessary. When you are taking sulfasalazine, it is especially important that your health care professional know if you are taking any of the following:

• Acetaminophen (e.g., Tylenol) (with long-term, high-dose use) or
• Amiodarone (e.g., Cordarone) or
• Anabolic steroids (nandrolone [e.g., Anabolin], oxandrolone [e.g., Anavar], oxymetholone [e.g., Anadrol], stanozolol [e.g., Winstrol]) or
• Androgens (male hormones) or
• Carbamazepine (e.g., Tegretol) or
• Carmustine (e.g., BiCNU) or
• Dantrolene (e.g., Dantrium) or
• Daunorubicin (e.g., Cerubidine) or
• Disulfiram (e.g., Antabuse) or
• Divalproex (e.g., Depakote) or
• Estrogens (female hormones) or
• Ethionamide (e.g., Trecator-SC) or
• Etretinate (e.g., Tegison) or
• Fat emulsions, intravenous (e.g., Intralipid) (with prolonged use) or
• Fluconazole (e.g., Diflucan) or
• Gold salts (drug for arthritis) or
• Inflammation or pain drug, except narcotics or
• Iron (with overdose) or
• Labetalol (e.g., Normodyne) or
• Lovastatin (e.g., Mevacor) or
• Mercaptopurine (e.g., Purinethol) or
• Methimazole (e.g., Tapazole) or
• Naltrexone (e.g., ReVia) (with long-term, high-dose use) or
• Niacin (with high doses, sustained release, and antihyperlipidemic use) or
• Nitrofurans or
• Other anti-infectives by mouth or by injection (drug for infection) or
• Phenothiazines (acetophenazine [e.g., Tindal], chlorpromazine [e.g., Thorazine], fluphenazine [e.g., Prolixin], mesoridazine [e.g., Serentil], perphenazine [e.g., Trilafon], prochlorperazine [e.g., Compazine], promazine [e.g., Sparine], promethazine [e.g., Phenergan], thioridazine [e.g., Mellaril], trifluoperazine [e.g., Stelazine], triflupromazine [e.g., Vesprin], trimeprazine [e.g., Temaril]) or
• Plicamycin (e.g., Mithracin) or
• Pravastatin (e.g., Pravachol) or
• Propylthiouracil (e.g., Propyl-Thyracil) or
• Simvastatin (e.g., Zocor) or
• Troleandomycin or
• Valproic acid (e.g., Depakene) or
• Vitamin A (with chronic overdose)–Use of sulfasalazine with these drugs may increase the chance of side effects affecting the liver

• Acetohydroxamic acid (e.g., Lithostat) or
• Dapsone or
• Furazolidone (e.g., Furoxone) or
• Menadiol (e.g., Synkavite) or
• Nitrofurantoin (e.g., Furadantin) or
• Primaquine or
• Procainamide (e.g., Pronestyl) or
• Quinidine (e.g., Quinidex) or
• Quinine (e.g., Quinamm) or
• Sulfoxone (e.g., Diasone)–Use of sulfasalazine with these drugs may increase the chance of side effects affecting the blood

• Anticoagulants (blood thinners) or
• Ethotoin (e.g., Peganone) or
• Mephenytoin (e.g., Mesantoin)–Use of sulfasalazine with these drugs may increase the chance of side effects of these drugs

• Antidiabetics, oral (diabetes drug you take by mouth)–Use of oral antidiabetics with sulfasalazine may increase the chance of side effects affecting the blood and/or increase the side effects of oral antidiabetics

• Methotrexate (e.g., Mexate)–Use of methotrexate with sulfasalazine may increase the chance of side effects affecting the liver and/or increase the side effects of methotrexate

• Methyldopa (e.g., Aldomet)–Use of methyldopa with sulfasalazine may increase the chance of side effects affecting the liver and/or the blood

• Phenytoin (e.g., Dilantin)–Use of phenytoin with sulfasalazine may increase the chance of side effects affecting the liver and/or increase the side effects of phenytoin

Other medicinal problems–The presence of other medicinal problems may affect the use of sulfasalazine. Make sure you tell your physician if you have any other medicinal problems, especially:

• Allergies, severe or
• Asthma, bronchial–The risk of an allergic reaction to sulfasalazine may be increased
• Blood problems or
• Glucose-6-phosphate dehydrogenase deficiency (lack of G6PD enzyme)–Patients with these problems may have an increase in side effects affecting the blood

• Intestinal blockage–Sulfasalazine will not reach the site of action in the bowel

• Kidney disease or
• Liver disease–Patients with kidney disease or liver disease may have an increased chance of side effects

• Porphyria–Use of sulfasalazine may cause an attack of porphyria

• Urinary blockage–Sulfasalazine may not be eliminated properly, causing an increased risk of side effects