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Tacrolimus Ointment Side Effects

Common Side Effects

Tacrolimus ointment has been studied extensively in clinical trials. In these studies, the side effects that occurred in a group of people using the drug were carefully documented and compared to the side effects reported by a group of people using a placebo ointment (an ointment with no active ingredients). As a result, it was possible to see what side effects occurred, how often they appeared, and how they compared to the group using the placebo.
 
In these clinical studies, the most commonly observed adverse reactions to tacrolimus ointment included:
 
  • Skin reactions, such as burning, stinging, and itching -- in up to 58 percent of people
  • Flu-like symptoms -- up to 34 percent
  • Skin redness -- up to 28 percent
  • Fever -- up to 21 percent
  • Headache -- up to 20 percent
  • Increased coughing -- up to 18 percent
  • Skin infection -- up to 16 percent
  • Allergic reaction to the medication -- up to 13 percent
  • Asthma -- up to 13 percent
  • Sore throat -- up to 12 percent
  • Ear infection -- up to 12 percent.
     
Other common side effects, occurring in 1 to 10 percent of people, included but were not limited to:
 
  • Infections, including urinary tract infection, pneumonia, and the common cold
  • Skin infections, including fungal infections, cold sores, chickenpox, and shingles
  • Stuffy nose
  • Tingling skin
  • Accidental injuries
  • Flushing (sudden warmth and redness of the skin) when drinking alcohol
  • Acne
  • Increased sensitivity of the skin to hot or cold temperatures
  • Vomiting
  • Rash
  • Swollen or infected hair follicles
  • Dry skin
  • Diarrhea
  • Stomach flu
  • Insomnia
  • Painful menstruation
  • Heartburn or indigestion
  • Swelling of the face, arms, hands, legs, ankles, or feet
  • Nausea
  • Pain, including back, muscle, joint, and abdominal (stomach) pain
  • Inflammation of the skin
  • Tingling, pricking, or numbing sensations of the skin
  • Swollen or enlarged lymph nodes
  • Worsening or new eczema
  • Cysts
  • Sunburn
  • Pink eye
  • Warts
  • Lack of energy
  • Depression
  • Cellulitis
  • Toothache or gum tissue problems
  • Increased blood pressure (hypertension)
  • Hair loss (alopecia).
     

Tacrolimus Ointment Information

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