Pimecrolimus
Side effects
Options:
Hide MedDRA Preferred Terms
MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
Headache
|
Headache
|
7.01% - 25.4%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervous system disorder
|
Nervous system disorder
|
7.01% - 25.4%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
4.27% - 19.4%
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
Infestation
|
Infestation NOS
|
4.27% - 19.4%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Infection
|
Infection
|
4.27% - 19.4%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
2.44% - 15.8%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nasopharyngitis
|
Nasopharyngitis
|
7.35% - 26.5%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhinorrhoea
|
0% - 1.9%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Application site pain
|
Application site burn
|
1.49% - 25.9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Application site burn
|
Application site burn
|
1.49% - 25.9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cough
|
Cough
|
2.4% - 15.8%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
1.2% - 12.5%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Influenza
|
Influenza
|
0.7% - 13.2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin infection
|
Skin infection
|
common, 2.2% - 6.62%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erythema
|
Erythema
|
common
|
|
x
|
|
|
|
|
|
|
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
0.305% - 6.67%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Immune system disorder
|
Immune system disorder
|
1.33% - 5.15%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
0.6% - 8%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing — 1.3% - 5.15%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain upper
|
Abdominal pain upper
|
0.3% - 6.7%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oropharyngeal discomfort
|
Throat sore
|
1.22% - 8.1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oropharyngeal pain
|
Throat sore
|
1.22% - 8.1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Impetigo
|
Impetigo
|
1.87% - 5.33%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Application site reaction
|
Application site reaction
|
0.61% - 14.6%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Application site irritation
|
Application site irritation
|
0.368% - 6.4%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Otitis media
|
Otitis media
|
0.6% - 5.33%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pruritus
|
Pruritus
|
postmarketing, common
|
|
x
|
|
|
|
|
|
|
x
|
Asthma
|
Asthma
|
0.299% - 3.7%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthma aggravated
|
0% - 3.9%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bronchitis
|
Bronchitis
|
0.375% - 10.7%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute bronchitis
|
0% - 1.5%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Folliculitis
|
Folliculitis
|
common, 0.7% - 20%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye disorder
|
Eye disorder
|
0.735% - 4%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Conjunctivitis
|
Other conjunctivitis
|
0.299% - 4%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Herpes simplex
|
Herpes simplex
|
0% - 4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ear infection
|
Ear infection
|
0.6% - 5.7%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastroenteritis
|
Gastroenteritis
|
0% - 7.4%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
0.375% - 6.7%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhinitis
|
Rhinitis
|
0% - 6.7%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nasal congestion
|
Nasal congestion
|
0.305% - 2.62%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bacterial infection
|
Bacterial infection
|
0% - 2.21%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sinusitis
|
Sinusitis
|
0.6% - 11%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Breast disorder
|
Breast disorder
|
0% - 1.49%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
0.299% - 7.72%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Loose stools
|
0% - 1.2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysmenorrhoea
|
Dysmenorrhoea
|
0% - 1.5%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Application site pruritus
|
Application site pruritus
|
0% - 5.5%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pneumonia
|
Pneumonia
|
0% - 1.5%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pharyngitis
|
Pharyngitis
|
0.7% - 8.1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Staphylococcal infection
|
Staphylococcal infection
|
0% - 3.7%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Varicella
|
Varicella
|
0% - 4%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
0.299% - 4.41%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
0.299% - 4.41%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhinorrhoea
|
Rhinorrhoea
|
0% - 1.9%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Viral infection
|
Viral infection
|
0% - 6.62%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ear pain
|
Ear pain
|
0% - 2.94%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sinus congestion
|
Sinus congestion
|
0.299% - 1.12%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Influenza like illness
|
Influenza like illness
|
0% - 2.7%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pharyngitis streptococcal
|
Pharyngitis streptococcal
|
0% - 3%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Toothache
|
Toothache
|
0.299% - 2.6%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Laceration
|
Laceration
|
0% - 1.5%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acne
|
Acne
|
0% - 1.83%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Wheezing
|
Wheezing
|
0% - 1.2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Back pain
|
Back pain
|
0% - 1.83%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin papilloma
|
Skin papilloma
|
0% - 3.31%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bone disorder
|
Bone disorder
|
0% - 1.83%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
0% - 3.7%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urticaria
|
Urticaria
|
postmarketing — 0% - 1.12%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Molluscum contagiosum
|
Molluscum contagiosum
|
0% - 1.84%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Viral upper respiratory tract infection
|
Viral upper respiratory tract infection
|
0% - 1.5%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Epistaxis
|
Epistaxis
|
0% - 3.31%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
0% - 1.52%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
0% - 1.52%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Herpes dermatitis
|
Herpes simplex dermatitis
|
0% - 1.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Application site erythema
|
Application site erythema
|
0% - 2.21%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
0% - 1.84%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye infection
|
Eye infection
|
0% - 1.1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaphylactic shock
|
Anaphylactic shock
|
postmarketing
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Angioedema
|
Angioedema
|
postmarketing, rare
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Neoplasm malignant
|
Neoplasm malignant
|
postmarketing
|
|
x
|
|
|
|
|
|
|
x
|
Basal cell carcinoma
|
Basal cell carcinoma
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Squamous cell carcinoma
|
Squamous cell carcinoma
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Dermatitis exfoliative
|
Dermatitis exfoliative
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
Dermatitis
|
Rash
|
postmarketing, rare
|
|
x
|
|
|
|
|
|
|
x
|
Rash
|
Rash
|
postmarketing, rare
|
|
x
|
|
|
|
|
|
|
x
|
Flushing
|
Flushing
|
postmarketing
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Lymphoma
|
Lymphoma
|
postmarketing
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Non-Hodgkin's lymphoma
|
Lymphoma
|
postmarketing
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Malignant melanoma
|
Malignant melanoma
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Neoplasm skin
|
Neoplasm skin
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
Swelling
|
Swelling
|
postmarketing
|
|
x
|
|
|
|
|
|
|
x
|
Alcohol intolerance
|
Alcohol intolerance
|
postmarketing, rare
|
|
x
|
|
|
|
|
|
|
x
|
Skin discolouration
|
Skin discolouration
|
postmarketing, rare
|
|
x
|
|
|
|
|
x
|
x
|
x
|
Skin hyperpigmentation
|
Skin hyperpigmentation
|
postmarketing, rare
|
|
x
|
|
|
|
|
|
|
x
|
Leukoderma
|
Leukoderma
|
postmarketing, rare
|
|
x
|
|
|
|
|
|
|
x
|
Eye irritation
|
Eye irritation
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
|
Face oedema
|
Face oedema
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
|
Skin cancer
|
Skin cancer
|
|
|
x
|
|
|
|
|
|
|
|
Oedema
|
Oedema
|
|
|
x
|
|
|
|
|
|
|
|
Malignant histiocytosis
|
Malignant histiocytosis
|
|
|
|
|
|
|
|
|
|
x
|
Extranodal NK/T-cell lymphoma, nasal type
|
Malignant histiocytosis
|
|
|
|
|
|
|
|
|
|
x
|
Leukaemia
|
Leukaemia
|
|
|
|
|
|
|
|
|
|
x
|
Pain
|
Pain
|
|
|
x
|
|
|
|
|
|
|
|
Paraesthesia
|
Paraesthesia
|
|
|
x
|
|
|
|
|
|
|
|
Superinfection
|
Superinfection
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tonsillitis
|
Tonsillitis
|
0% - 6.3%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tracheobronchitis
|
Acute bronchitis
|
0% - 1.5%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin atrophy
|
Skin atrophy
|
|
|
|
|
|
|
|
|
|
x
|
Malnutrition
|
Malnutrition
|
|
|
x
|
|
|
|
|
|
|
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
x
|
|
|
|
|
|
|
|
Condition aggravated
|
Condition aggravated
|
|
|
x
|
|
|
|
|
|
|
|
Skin exfoliation
|
Skin exfoliation
|
|
|
x
|
|
|
|
|
|
|
|
Furuncle
|
Furuncle
|
|
|
x
|
|
|
|
|
|
|
|
Colon cancer
|
Carcinoma colon
|
|
|
|
|
|
|
|
|
|
x
|
Eczema herpeticum
|
Eczema herpeticum
|
|
|
x
|
|
|
|
|
|
|
|
Sensitisation
|
Sensitisation
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Photosensitivity reaction
|
Phototoxicity
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthritis bacterial
|
Arthritis bacterial
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Indications
Information about indications was extracted from the indications and usage sections of the labels.
Side effects: | 34 |
Source: | Medsafe |
---|
Side effects: | 74 |
Source: | FDA |
---|
Side effects: | 75 |
Source: | FDA |
---|
Side effects: | 76 |
Source: | FDA Structured Product Label |
---|
Side effects: | 84 |
Source: | FDA |
---|
Side effects: | 86 |
Source: | FDA Structured Product Label |
---|
Side effects: | 86 |
Source: | FDA |
---|
Side effects: | 92 |
Source: | Health Canada |
---|
Color scheme:
standard – alternative
|
|
100%
|
|
|
75%
|
|
|
50%
|
|
|
10%
|
|
|
frequent (1% to 100%)
|
|
|
infrequent (0.1% to 1%)
|
|
|
rare (<0.1%)
|
|
|
postmarketing
|
|
|
0%
|
|
|
no frequency information
|
|
|
not found on label
|