Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes Protopic (Tacrolimus-topical). If you are concerned about side effects, discuss the risks and benefits of Protopic (Tacrolimus-topical) with your doctor.

The following side effects have been reported by at least 1% of people taking Protopic (Tacrolimus-topical). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Acne
• cysts (closed pouches of tissue filled with materials such as air, fluid, or pus)
• Diarrhea
• Fever
• flu-like symptoms (e.g., congestion, coughing, or sneezing)
• flushing or redness of the skin or face after drinking alcohol
• headache
• herpes zoster infection (Chickenpox or Shingles)
• increased sensitivity of the skin to hot or cold temperatures
• muscle pain
• skin infection in the area where the medication was applied
• skin tingling
• stinging, burning, or itching of the skin area being treated
• swollen or infected hair follicles
• upset stomach

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., Hives, difficulty breathing, swelling of the face or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Protopic (Tacrolimus-topical).

Each gram of white to slightly yellowish ointment contains either 0.03% or 0.1% tacrolimus. Nonmedicinal ingredients: mineral oil, paraffin, propylene carbonate, white petrolatum, and white wax.

Tacrolimus topical ointment should not be used by anyone who is allergic to tacrolimus or to any of the ingredients of the medication.

There may be an interaction between tacrolimus topical ointment and any of the following:

• alcohol
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• calcium channel blockers (e.g., Diltiazem, Verapamil)
• Danazol
• grapefruit juice
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
• medications that weaken the immune system
• Azathioprine
• corticosteroids (e.g., budesonide, Dexamethasone, Hydrocortisone, fluticasone, Prednisone)
• Cyclosporine
• Fingolimod
• Hydroxyurea
• Infliximab
• Leflunomide
• medications to treat cancer (e.g., Carboplatin, Cyclophosphamide, Doxorubicin, Ifosfamide, Vincristine)
• mycophenolate
• Rituximab
• Sirolimus
• other forms of tacrolimus
• other medications applied to the skin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Protopic (Tacrolimus-topical). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Protopic (Tacrolimus-topical).

Infections: Before you start treatment with tacrolimus topical ointment, you should be free of infections. Long-term use of Protopic (Tacrolimus-topical) may increase the risk of developing infections.

Kidney function: If you are applying tacrolimus topical ointment over a large part of your body, it may be absorbed through the skin, which can affect kidney function. If you have reduced kidney function or Kidney Disease, discuss with your doctor how Protopic (Tacrolimus-topical) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Protopic (Tacrolimus-topical), and whether any special monitoring is needed.

Skin Cancer and other cancers: Although rare, there have been reports of skin cancer and lymphoma in people using tacrolimus topical ointment. The relationship between long-term use of Protopic (Tacrolimus-topical) and certain types of skin cancers or lymphomas has not been established. Discuss any concerns you have with your doctor.

Skin reaction: During the first few days of treatment with Protopic (Tacrolimus-topical), you may experience skin reactions (e.g., burning sensation, stinging, soreness). This is normal and usually goes away after a short period of time.

Sun exposure: If you use tacrolimus topical ointment, protect yourself from too much sun exposure. Use a sunscreen with a sun protection factor (SPF) of at least 30, wear hats and long-sleeved clothing, and avoid the sun during its strongest times (between 10 am and 4 pm). Avoid tanning beds and other ultraviolet (UV) A or B treatments while using Protopic (Tacrolimus-topical).

Pregnancy: Protopic (Tacrolimus-topical) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while using Protopic (Tacrolimus-topical), contact your doctor immediately.

Breast-feeding: Protopic (Tacrolimus-topical) passes into breast milk. If you are a breast-feeding mother and are using tacrolimus topical ointment, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using tacrolimus topical ointment have not been established for children under 2 years of age. Children aged 2 to 15 years should use the 0.03% strength of tacrolimus ointment only.