Drug information for ELIDEL
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
CREAM; TOPICAL
1%
Prescription
(Reference Drug)
PIMECROLIMUS
pimecrolimus
VALEANT INTL
21302
2011-01-13 Medication Guide
2010-07-23 Letter
2010-07-22 Label
2007-08-14 Letter
2007-08-14 Label
2006-01-30 Letter
2006-01-19 Label
2006-01-19 Medication Guide
2004-12-03 Label
2004-12-02 Letter
2003-10-17 Letter
2003-10-17 Label
2001-12-13 Letter
2001-12-13 Label
2001-12-13 Review
Drug Adverse Effects information for ELIDEL
Role code
Indications
Reaction
# Reports
PS
DERMATITIS ATOPIC
BLISTER
1
PS
DERMATITIS ATOPIC
INFLAMMATION
1
PS
DERMATITIS ATOPIC
PRURITUS
1
PS
DERMATITIS ATOPIC
SWELLING FACE
1
PS
DERMATITIS ATOPIC
TENDERNESS
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
DERMATITIS ATOPIC
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
HODGKIN'S DISEASE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
INCORRECT DOSE ADMINISTERED
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
MATERNAL EXPOSURE DURING PREGNANCY
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
PREGNANCY
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
PUBIC PAIN
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
UNEVALUABLE EVENT
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
VARICOSE VEIN
1
PS
VITILIGO
BLOOD PRESSURE SYSTOLIC INCREASED
1
C
ANKYLOSING SPONDYLITIS
SKIN DISCOMFORT
1
C
ARTHRALGIA
CLOSTRIDIAL INFECTION
1
C
ARTHRALGIA
FATIGUE
1
C
BONE DENSITOMETRY
CLOSTRIDIAL INFECTION
1
C
BONE DENSITOMETRY
FATIGUE
1
C
CONSTIPATION
CLOSTRIDIAL INFECTION
1
C
CONSTIPATION
FATIGUE
1
C
CONVULSION
CLOSTRIDIAL INFECTION
3
C
CONVULSION
FATIGUE
3
C
DERMATITIS ATOPIC
ASTHMA
1
C
DERMATITIS ATOPIC
OFF LABEL USE
1
C
HEADACHE
CLOSTRIDIAL INFECTION
1
C
HEADACHE
FATIGUE
1
C
HYPERSENSITIVITY
ASTHMA
1
C
HYPERSENSITIVITY
OFF LABEL USE
1
C
HYPOTHYROIDISM
CLOSTRIDIAL INFECTION
1
C
HYPOTHYROIDISM
FATIGUE
1
C
METASTASES TO BONE
ABDOMINAL PAIN UPPER
1
C
METASTASES TO BONE
ABSCESS
1
C
METASTASES TO BONE
ACTINOMYCOSIS
1
C
METASTASES TO BONE
ANAEMIA
1
C
METASTASES TO BONE
ANEURYSM
1
C
METASTASES TO BONE
AORTIC VALVE INCOMPETENCE
1
C
METASTASES TO BONE
ARTERIOSCLEROSIS
1
C
METASTASES TO BONE
ASTHENIA
1
C
METASTASES TO BONE
BALANCE DISORDER
1
C
METASTASES TO BONE
BIOPSY BONE
1
C
METASTASES TO BONE
BONE DISORDER
1
C
METASTASES TO BONE
BONE LOSS
1
C
METASTASES TO BONE
BUNDLE BRANCH BLOCK LEFT
1
C
METASTASES TO BONE
CELLULITIS
1
C
METASTASES TO BONE
CHEST PAIN
1
C
METASTASES TO BONE
CHOLELITHIASIS
1
C
METASTASES TO BONE
COLONIC POLYP
1
C
METASTASES TO BONE
CONSTIPATION
1
C
METASTASES TO BONE
DECREASED APPETITE
1
C
METASTASES TO BONE
DEHYDRATION
1
C
METASTASES TO BONE
DERMOID CYST
1
C
METASTASES TO BONE
DIARRHOEA
1
C
METASTASES TO BONE
DIVERTICULUM INTESTINAL
1
C
METASTASES TO BONE
DIZZINESS
1
C
METASTASES TO BONE
DRUG INTOLERANCE
1
C
METASTASES TO BONE
DYSPHAGIA
1
C
METASTASES TO BONE
DYSPNOEA
1
C
METASTASES TO BONE
DYSURIA
1
C
METASTASES TO BONE
ERYTHEMA
1
C
METASTASES TO BONE
EXOSTOSIS
1
C
METASTASES TO BONE
GASTRIC POLYPS
1
C
METASTASES TO BONE
GASTRITIS
1
C
METASTASES TO BONE
GINGIVAL SWELLING
1
C
METASTASES TO BONE
GLOSSODYNIA
1
C
METASTASES TO BONE
HAEMATOCHEZIA
1
C
METASTASES TO BONE
HAEMATURIA
1
C
METASTASES TO BONE
HAEMORRHOIDS
1
C
METASTASES TO BONE
HEADACHE
1
C
METASTASES TO BONE
HIATUS HERNIA
1
C
METASTASES TO BONE
HYPOVOLAEMIA
1
C
METASTASES TO BONE
INTERVERTEBRAL DISC DEGENERATION
1
C
METASTASES TO BONE
LEFT ATRIAL DILATATION
1
C
METASTASES TO BONE
MASS
1
C
METASTASES TO BONE
MITRAL VALVE INCOMPETENCE
1
C
METASTASES TO BONE
MOUTH ULCERATION
1
C
METASTASES TO BONE
MOVEMENT DISORDER
1
C
METASTASES TO BONE
NAUSEA
1
C
METASTASES TO BONE
OEDEMA MOUTH
1
C
METASTASES TO BONE
OESOPHAGEAL STENOSIS
1
C
METASTASES TO BONE
ORAL CAVITY FISTULA
1
C
METASTASES TO BONE
ORAL DISCOMFORT
1
C
METASTASES TO BONE
ORAL DISORDER
1
C
METASTASES TO BONE
ORTHOSTATIC HYPOTENSION
1
C
METASTASES TO BONE
OSTEOARTHRITIS
1
C
METASTASES TO BONE
OSTEOMYELITIS
1
C
METASTASES TO BONE
OSTEONECROSIS OF JAW
1
C
METASTASES TO BONE
PAIN IN JAW
1
C
METASTASES TO BONE
PALPITATIONS
1
C
METASTASES TO BONE
PERIODONTITIS
1
C
METASTASES TO BONE
PRIMARY SEQUESTRUM
1
C
METASTASES TO BONE
PROSTATIC SPECIFIC ANTIGEN INCREASED
1
C
METASTASES TO BONE
PURULENT DISCHARGE
1
C
METASTASES TO BONE
RENAL CYST
1
C
METASTASES TO BONE
RHINITIS ALLERGIC
1
C
METASTASES TO BONE
SINUS DISORDER
1
C
METASTASES TO BONE
STREPTOCOCCAL INFECTION
1
C
METASTASES TO BONE
SWELLING FACE
1
C
METASTASES TO BONE
TOOTH INFECTION
1
C
METASTASES TO BONE
URINARY INCONTINENCE
1
C
METASTASES TO BONE
VOMITING
1
C
METASTASES TO BONE
WEIGHT DECREASED
1
C
METASTASES TO BONE
WOUND DEHISCENCE
1
C
MULTIPLE SCLEROSIS
CLOSTRIDIAL INFECTION
1
C
MULTIPLE SCLEROSIS
FATIGUE
1
C
MUSCLE SPASMS
CLOSTRIDIAL INFECTION
1
C
MUSCLE SPASMS
FATIGUE
1
C
NAUSEA
CLOSTRIDIAL INFECTION
1
C
NAUSEA
FATIGUE
1
C
PAIN
CLOSTRIDIAL INFECTION
4
C
PAIN
FATIGUE
4
C
POOR QUALITY SLEEP
CLOSTRIDIAL INFECTION
1
C
POOR QUALITY SLEEP
FATIGUE
1
C
PRODUCT USED FOR UNKNOWN INDICATION
ASTHMA
6
C
PRODUCT USED FOR UNKNOWN INDICATION
OFF LABEL USE
6
C
PRURITUS
ASTHMA
2
C
PRURITUS
OFF LABEL USE
2
C
RASH
ASTHMA
1
C
RASH
OFF LABEL USE
1
C
SINUS DISORDER
CLOSTRIDIAL INFECTION
1
C
SINUS DISORDER
FATIGUE
1
C
SKIN FISSURES
CLOSTRIDIAL INFECTION
1
C
SKIN FISSURES
FATIGUE
1
C
SLEEP DISORDER
CLOSTRIDIAL INFECTION
1
C
SLEEP DISORDER
FATIGUE
1
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