Summary
Commonly reported side effects of pimecrolimus topical include: application site reaction and localized burning. Other side effects include: local irritation and local pruritus. Continue reading for a comprehensive list of adverse effects.
Applies to pimecrolimus topical: topical cream.
Warning
Topical route (Cream)
Long-term safety of topical calcineurin inhibitors has not been established, and rare cases of malignancy (eg, skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors including pimecrolimus. Avoid continuous long-term use in any age group and apply to limited areas affected by atopic dermatitis. Not indicated for use in children less than 2 years of age.
Serious side effects
Along with its needed effects, pimecrolimus topical may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking pimecrolimus topical:
More common
- Abdominal or stomach pain
- body aches or pain
- burning, itching, redness, skin rash, swelling, or soreness at the application site
- change in hearing
- chills
- cold or flu-like symptoms
- congestion (ear or nasal)
- cough producing mucus
- diarrhea
- difficulty with breathing or shortness of breath
- dryness or soreness of the throat
- earache or pain in the ear
- ear drainage
- fever
- general feeling of discomfort or illness
- headache
- hoarseness
- itching
- joint pain
- loss of appetite
- loss of voice
- muscle aches and pains
- nausea
- pain
- redness
- runny nose
- shivering
- sneezing
- sweating
- swelling
- tenderness
- tender, swollen glands in the neck
- tightness in the chest
- trouble with swallowing
- trouble with sleeping
- unusual tiredness or weakness
- voice changes
- vomiting
- warmth on the skin
- wheezing
Less common
- Blistering, crusting, irritation, itching, or reddening of the skin
- blurred vision or other change in vision
- eye pain
- fast heartbeat
- hives
- itchy, raised, round, smooth, skin-colored bumps found on just one area of the body that are oozing, thick, white fluid
- irritation
- joint pain, stiffness or swelling
- rash
- redness of the eye
- redness of the skin
- sensitivity of the eyes to light
- skin rash on the face, scalp, or stomach
- swelling of the eyelids, face, lips, hands, or feet
- tearing
- troubled breathing or swallowing
Incidence not known
- Black, tarry stools
- change in size, shape, or color of existing mole
- cough
- dizziness
- itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- large, hive-like swelling on the face
- mole that leaks fluid or bleeds
- new mole
- small, red skin lesion, growth, or bump usually on the face, ears, neck, hands, or arms
- sores that will not heal
- weight loss
- yellow eyes and skin
Other side effects
Some side effects of pimecrolimus topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Burning, itching, and pain in hairy areas
- pus at the root of the hair
Less common
- Blemishes on the skin
- bloody nose
- burning or stinging of the skin
- difficulty having a bowel movement (stool)
- flushing; redness of skin; unusually warm skin at site
- heavy bleeding
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- pimples
- redness or swelling in the ear
- vaginal pain and cramps
Incidence not known
- Burning, stinging, itching, or mild discomfort of the eye (after applying the cream to the eyelids or near the eyes)
- feeling of warmth (with alcohol use)
- redness of the face, neck, arms, and occasionally, upper chest (with alcohol use)
For Healthcare Professionals
Applies to pimecrolimus topical: topical cream.
Dermatologic
Common (1% to 10%): Folliculitis, acne
Uncommon (0.1% to 1%): Furuncle, impetigo, herpes simplex, herpes zoster, skin papilloma, molluscum contagiosum, urticaria
Rare (less than 0.1%): Rash, angioedema, skin discoloration (e.g., hypopigmentation, hyperpigmentation)[Ref]
Gastrointestinal
Common (1% to 10%): Gastroenteritis, sore throat, diarrhea, nausea
Uncommon (0.1% to 1%): Tonsillitis, upper abdominal pain, vomiting, toothache[Ref]
Genitourinary
Common (1% to 10%): Dysmenorrhea[Ref]
Hypersensitivity
Very rare (less than 0.01%): Anaphylaxis[Ref]
Immunologic
Common (1% to 10%): Influenza
Uncommon (0.1% to 1%): Molluscum contagiosum, staphylococcal infection, chickenpox[Ref]
Local
Very common (10% or more): Application site burning (26%), application site reactions (i.e., irritation, pruritus erythema) (14.6%)
Common (1% to 10%): Application site irritation
Uncommon (0.1% to 1%): Application site disorders (i.e., rash, pain, paresthesia, desquamation, dryness, edema)[Ref]
Musculoskeletal
Common (1% to 10%): Back pain, arthralgia[Ref]
Nervous system
Common (1% to 10%): Headache[Ref]
Metabolic
Rare (less than 0.1%): Alcohol intolerance (in most cases, flushing, rash, burning, itching, or swelling occurred shortly after the intake of alcohol)[Ref]
Oncologic
Postmarketing reports: Cutaneous and other types of lymphoma, skin cancers[Ref]
Other
Common (1% to 10%): Pyrexia
Uncommon (0.1% to 1%): Ear infection, otitis media[Ref]
Ocular
Common (1% to 10%): Conjunctivitis
Uncommon (0.1% to 1%): Eye infection[Ref]
Respiratory
Common (1% to 10%): Influenza, nasopharyngitis, upper respiratory infection, cough, asthma, rhinitis, bronchitis
Uncommon (0.1% to 1%): Sinus congestion, pharyngitis, nasal congestion, tonsillitis, sinusitis, dyspnea, epistaxis, pneumonia, viral upper respiratory tract infection, pharyngolaryngeal pain[Ref]
