Dexamethasone Intensol

Serious side effects have been reported with dexamethasone. See the “Dexamethasone Precautions” section.

Oral and injectable forms:

Common side effects of oral and injectable forms of dexamethasone include the following:

• upset stomach
• stomach irritation
• vomiting
• headache
• dizziness
• insomnia
• restlessness
• depression
• anxiety
• acne
• increased hair growth
• easy bruising
• irregular or absent menstrual periods
• increased appetite and weight gain

Intravitreal form:

Common side effects of the dexamethasone intravitreal implant include increased intraocular pressure and conjunctival hemorrhage.

This is not a complete list of dexamethasone side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Aminoglutethimide (Cytadren)
• Amphotericin B (Amphocin, Fungizone Intravenous)
• Cholesterol-lowering drugs
• Anticoagulants such as warfarin (Coumadin)
• Antidiabetic agents
• Isoniazid (Hyzyd, Laiazid, INH, Nydrazid, Rimifon, Stanozide, Tubizid)
• Cholestyramine (Locholest, Prevalite, Questran)
• Cyclosporine (Neoral, Sandimmune)
• Digoxin (Lanoxin)
• Diuretics
• Ephedrine
• Estrogens, including oral contraceptives
• Barbiturates such as phenobarbital
• Phenytoin (Dilantin)
• Carbamazepine (Carbatrol, Epitol, Tegretol)
• Rifampin (Rifadin)
• Ketoconazole (Nizoral)
• Erythromycin (EES, ERY-C, Ery-Tab, Erythrocin, Pediamycin)
• Indinavir (Crixivan)
• Nonsteroidal anti-inflammatory drugs, including aspirin, ibuprofen (Motrin), naproxen (Aleve), celecoxib (Celebrex), and piroxicam (Feldene)
• Thalidomide (Thalomid)
• Theophylline (Theo-Dur)

This is not a complete list of dexamethasone drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with oral and injectable forms of dexamethasone including the following:

Fluid and electrolyte disturbances. Tell your healthcare provider right away if you have some or all of the following symptoms of a fluid or electrolyte disturbance:

• Fluid retention
• Increased blood pressure

Muscle or skeletal problems. Tell your healthcare provider right away if you have some or all of the following symptoms of a muscle or skeletal problem:

• Muscle weakness
• Muscle pain
• Loss of muscle mass
• Osteoporosis
• Compression fractures of the vertebrae
• Tendon rupture

​Gastrointestinal upset. Tell your healthcare provider right away if you have some or all of the following symptoms of gastrointestinal upset:

• Peptic ulcer
• Inflammation of the pancreas
• Abdominal distention or bloating

​Dermatologic complications. Tell your healthcare provider right away if you have some or all of the following symptoms of a dermatologic complication:

• Skin wounds that will not heal
• Redness, itching, or swelling of the skin
• Increased sweating
• Petechiae or ecchymosis, which are small red or purple spots or discolorations on the body caused by broken blood vessels under the skin
• Changes in the color of the skin

​Neurologic reactions. Tell your healthcare provider right away if you have some or all of the following symptoms of a neurologic reaction:

• Convulsions
• Vertigo
• Headache
• Psychic disturbances

​Endocrine abnormalities. Tell your healthcare provider right away if you have some or all of the following symptoms of endocrine abnormalities:

• Menstrual irregularities
• Growth suppression in children
• Onset or worsening of diabetes mellitus
• Increased hair growth

​Ophthalmic complications. Tell your healthcare provider right away if you have some or all of the following symptoms of ophthalmic complications:

• Increased intraocular pressure
• Glaucoma
• Exophthalmus

​Myocardial rupture following recent heart attack.

Serious side effects have been reported with the dexamethasone intravitreal implant including inflammation of the eye, increased intraocular pressure, glaucoma, and retinal detachment.

Do not take dexamethasone if you:

• are allergic to dexamethasone or to any of its ingredients
• have a systemic fungal infection

Patients who are taking dexamethasone should not receive live or live, attenuated vaccines. Killed or inactivated vaccines may be administered, but the patient’s response to the vaccines cannot be predicted.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of dexamethasone, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking dexamethasone, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to dexamethasone or to any of its ingredients
• are allergic to aspirin
• are allergic to tartrazine (a yellow dye used in processed foods and drugs)
• have a systemic fungal infection
• have or have had liver problems
• have or have had heart problems
• have or have had kidney problems
• have or have had intestinal problems
• have or have had diabetes
• have or have had thyroid problems
• have or have had high blood pressure
• have or have had mental illness
• have myasthenia gravis
• have osteoporosis
• have or have had seizures
• have or have had tuberculosis
• have or have had ulcers
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Dexamethasone falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Dexamethasone has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from dexamethasone, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Your dose needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using dexamethasone.

Do not stop using dexamethasone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Wear a medical alert tag or carry an ID card stating that you take dexamethasone. Any medical care provider who treats you should know that you are using steroid medication.

Store at room temperature away from moisture and heat.

Many drugs can interact with dexamethasone. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

• aspirin (taken on a daily basis or at high doses);

• cyclosporine;

• digoxin;

• an antibiotic such as erythromycin or rifampin;

• antifungal medicine such as ketoconazole;

• birth control pills or hormone replacement therapy;

• a blood thinner such as warfarin (Coumadin, Jantoven);

• a diuretic (water pill);

• glaucoma medication;

• insulin or diabetes medications you take by mouth;

• medicine to treat dementia or Parkinson's disease;

• an NSAID (nonsteroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, meloxicam, and others; or

• seizure medications such as carbamazepine, phenytoin, or phenobarbital.

This list is not complete and many other drugs can interact with dexamethasone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any unwanted effects that may be caused by this medicine. Blood or urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

If you are using this medicine for a long time, tell your doctor about any extra stress or anxiety in your life, including other health concerns and emotional stress. Your dose of this medicine might need to be changed for a short time while you have extra stress.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor right away if you have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

While you are being treated with dexamethasone, do not have any immunizations (vaccines) without your doctor's approval. Dexamethasone may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine might cause thinning of the bones (osteoporosis) or slow growth in children if used for a long time. Tell your doctor if you have any bone pain or if you have an increased risk for osteoporosis. If your child is using this medicine, tell the doctor if you think your child is not growing properly.

This medicine may cause changes in mood or behavior for some patients. Tell your doctor right away if you have depression; mood swings; a false or unusual sense of well-being; trouble with sleeping; or personality changes while taking this medicine.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain skin tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.