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Elidel Side Effects

Generic Name: pimecrolimus topical

Note: This document contains side effect information about pimecrolimus topical. Some of the dosage forms listed on this page may not apply to the brand name Elidel.

In Summary

Common side effects of Elidel include: application site reaction and localized burning. Other side effects include: local irritation and local pruritus. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to pimecrolimus topical: topical cream

Along with its needed effects, pimecrolimus topical (the active ingredient contained in Elidel) 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

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]

References

1. "Product Information. Elidel (pimecrolimus topical)." Novartis Pharmaceuticals, East Hanover, NJ.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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