Pimecrolimus (Topical Route)

Side Effects

Drug information provided by: Merative, Micromedex®

Along with its needed effects, a medicine 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:

More common

1. Abdominal or stomach pain
2. body aches or pain
3. burning, itching, redness, skin rash, swelling, or soreness at the application site
4. change in hearing
5. chills
6. cold or flu-like symptoms
7. congestion (ear or nasal)
8. cough producing mucus
9. diarrhea
10. difficulty with breathing or shortness of breath
11. dryness or soreness of the throat
12. earache or pain in the ear
13. ear drainage
14. fever
15. general feeling of discomfort or illness
16. headache
17. hoarseness
18. itching
19. joint pain
20. loss of appetite
21. loss of voice
22. muscle aches and pains
23. nausea
24. pain
25. redness
26. runny nose
27. shivering
28. sneezing
29. sweating
30. swelling
31. tenderness
32. tender, swollen glands in the neck
33. tightness in the chest
34. trouble with swallowing
35. trouble with sleeping
36. unusual tiredness or weakness
37. voice changes
38. vomiting
39. warmth on the skin
40. wheezing

Less common

1. Blistering, crusting, irritation, itching, or reddening of the skin
2. blurred vision or other change in vision
3. eye pain
4. fast heartbeat
5. hives
6. itchy, raised, round, smooth, skin-colored bumps found on just one area of the body that are oozing, thick, white fluid
7. irritation
8. joint pain, stiffness or swelling
9. rash
10. redness of the eye
11. redness of the skin
12. sensitivity of the eyes to light
13. skin rash on the face, scalp, or stomach
14. swelling of the eyelids, face, lips, hands, or feet
15. tearing
16. troubled breathing or swallowing

Incidence not known

1. Black, tarry stools
2. change in size, shape, or color of existing mole
3. cough
4. dizziness
5. itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
6. large, hive-like swelling on the face
7. mole that leaks fluid or bleeds
8. new mole
9. small, red skin lesion, growth, or bump usually on the face, ears, neck, hands, or arms
10. sores that will not heal
11. weight loss
12. yellow eyes and skin

Some side effects 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

1. Burning, itching, and pain in hairy areas
2. pus at the root of the hair

Less common

1. Blemishes on the skin
2. bloody nose
3. burning or stinging of the skin
4. difficulty having a bowel movement (stool)
5. flushing; redness of skin; unusually warm skin at site
6. heavy bleeding
7. painful cold sores or blisters on the lips, nose, eyes, or genitals
8. pimples
9. redness or swelling in the ear
10. vaginal pain and cramps

Incidence not known

1. Burning, stinging, itching, or mild discomfort of the eye (after applying the cream to the eyelids or near the eyes)
2. feeling of warmth (with alcohol use)
3. redness of the face, neck, arms, and occasionally, upper chest (with alcohol use)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Precautions

Portions of this document last updated: Feb. 01, 2023