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Pimecrolimus topical Side Effects

In Summary

Commonly reported side effects of pimecrolimus topical 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

As well as its needed effects, pimecrolimus topical may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking pimecrolimus topical, check with your doctor immediately:

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

Minor Side Effects

Some pimecrolimus topical side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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. "UK Summary of Product Characteristics." O 0

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

It is possible that some side effects of pimecrolimus topical may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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