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Protopic (Tacrolimus Topical) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

No phototoxicity and no photoallergenicity were detected in clinical studies with 12 and 216 normal volunteers, respectively. One out of 198 normal volunteers showed evidence of sensitization in a contact sensitization study.

In three 12 week randomized vehicle-controlled studies and four safety studies, 655 and 9,163 patients respectively, were treated with PROTOPIC Ointment. The duration of follow-up for adult and pediatric patients in the safety studies is tabulated below.

Duration of Follow-up in Four Open-label Safety Studies
Time on Study Adult Pediatrics Total
less than 1 year 4682 4481 9163
greater than or equal to 1 year 1185 1349 2534
greater than or equal to 2 years 200 275 475
greater than or equal to 3 years 118 182 300

The following table depicts the adjusted incidence of adverse events pooled across the 3 identically designed 12-week controlled studies for patients in vehicle, PROTOPIC Ointment 0.03%, and PROTOPIC Ointment 0.1% treatment groups. The table also depicts the unadjusted incidence of adverse events in four safety studies, regardless of relationship to study drug.

Incidence of Treatment Emergent Adverse Events
12-Week, Randomized, Double-Blink, Phase 3 Studies                                  Open-Label Studies (up to 3 years)
                                                                                                                                0.1% and 0.03% Tacrolimus
        12-Week Adjusted Incidence Rate (%)                                                        Ointment Incidence Rate (%) 
                                                                


Adult

Pediatric

Adult
Pediatric
Total

Vehicle
(n=212)
%


0.03%
Tacrolimus
Ointment
(n=210)
%
0.1%
Tacrolimus
Ointment
(n=209)
%
Vehicle
(n=116)
%


0.03%
Tacrolimus
Ointment
(n=118)
%
(n-4682)%




(n=4481)%




(n=9163)%




Skin Burning*
26
46
58
29
43
28
20
24
Pruritus*
37
46
46
27
41
25
19
22
Flue-like
symptoms*
19
23
31
25
28
22
34
28
Allergic Reaction
8
12
6
8
4
9
13
11
Skin Erythema
20
25
28
13
12
12
7
9
Headache*
11
20
19
8
5
13
9
11
Skin Infection
11
12
5
14
10
9
16
12
Fever
4
4
1
13
21
2
14
8
Infection
1
1
2
9
7
6
10
8
Cough Increased
2
1
1
14
18
3
10
6
Asthma
4
6
4
6
6
4
13
8
Herpes Simplex
4
4
4
2
0
4
3
3
Eczema
Herpeticum
0
1
1
0
2
0
0
0
Pharyngitis
3
3
4
11
6
4
12
8
Accidental Injury
4
3
6
3
6
6
8
7
Pustular Rash
2
3
4
3
2
2
7
5
Folliculitis*
1
6
4
0
2
4
2
3
Rhinitis
4
3
2
2
6
2
4
3
Otis Media
4
0
1
6
12
2
11
6
Sinusitis*
1
4
2
8
3
6
7
6
Diarrhea
3
3
4
2
5
2
4
3
Urticaria
3
3
6
1
1
3
4
4
Lack of Drug
Effect
1
1
0
1
1
6
6
6
Bronchitis
0
2
2
3
3
4
4
4
Vomiting
0
1
1
7
6
1
4
3
Maculopapular
Rash
2
2
2
3
0
2
1
1
Rash*
1
5
2
4
2
2
3
3
Abdominal Pain
3
1
1
2
3
1
3
2
Fungal Dermatitis
0
2
1
3
0
2
4
3
Gastroentesritis
1
2
2
3
0
2
4
3
Alcohol
Intolerance*
0
3
7
0
0
4
0
2
Acne*
2
4
7
1
0
3
2
3
Sunburn
1
2
1
0
0
2
1
1
Skin Disorder
2
2
1
1
4
2
2
2
Conjunctivitis
0
2
2
2
1
3
3
3
Pain
1
2
1
0
1
2
1
2
Vesiculobullous
Rash*
3
3
2
0
4
2
1
1
Lymphadenopathy
2
2
1
0
3
1
2
1
Nausea
4
3
2
0
1
2
1
2
Skin Tingling*
2
3
8
1
2
2
1
1
Face Edema
2
2
1
2
1
1
1
1
Dyspepsia*
1
1
4
0
0
2
2
2
Dry Skin
7
3
3
0
1
1
1
1
Hypersthesia*
1
3
7
0
0
2
0
1
Skin Neoplasm
Benign †
1
1
1
0
0
1
2
2
Back Pain*
0
2
2
1
1
3
0
2
Peripheral Edema
2
4
3
0
0
2
0
1
Varicella
Zoster/Herpes
Zoster * ‡
0
1
0
0
5
1
2
2
Contact Dermatitis
1
3
3
3
4
2
2
2
Asthena
1
2
3
0
0
1
0
1
Pneumonia
0
1
1
2
0
1
3
2
Eczema
2
2
2
0
0
1
0
1
Insomnia
3
4
3
1
1
2
0
1
Exfoliative
Dermatitis
3
3
1
0
0
0
1
0
Dysmenorrhea
2
4
4
0
0
2
1
1
Periodontal
Abscess
1
0
1
0
0
1
1
1
Myalgia*
0
3
2
0
0
2
1
1
Cyst*
0
1
3
0
0
1
0
1
Cellulitis
1
1
1
0
0
1
1
1
Exacerbation of
Untreated Area
1
0
1
1
0
1
1
1
Procedural
Complication
1
0
0
1
0
1
1
1
Hypertension
0
0
1
0
0
2
0
1
Tooth Disorder
0
1
1
1
0
2
1
1
Arthralgia
1
1
3
2
0
2
1
2
Depression
1
2
1
0
0
1
0
1
Paresthesia
1
3
3
0
0
2
1
2
Alopecia
0
1
1
0
0
1
1
1
Urinary Tract
Infection
0
0
1
0
0
2
1
2
Ear Pain
1
0
1
0
1
0
1
1
*   May be reasonably associated with the use of this drug product
†     Generally "warts".
‡     All the herpes zoster cases in the pediatric 12-week study and the majority of cases in the open-label pediatric studies were reported as chicken pox.


Other adverse events which occurred at an incidence between 0.2% and less than 1% in clinical studies in the above table include: abnormal vision, abscess, anaphylactoid reaction, anemia, anorexia, anxiety, arthritis, arthrosis, bilirubinemia, blepharitis, bone disorder, breast neoplasm benign, bursitis, cataract NOS, chest pain, chills, colitis, conjunctival edema, constipation, cramps, cutaneous moniliasis, cystitis, dehydration, dizziness, dry eyes, dry mouth/nose, dyspnea, ear disorder, ecchymosis, edema, epistaxis, eye pain, furunculosis, gastritis, gastrointestinal disorder, hernia, hypercholesterolemia, hypertonia, hypothyroidism, joint disorder, laryngitis, leukoderma, lung disorder, malaise, migraine, moniliasis, mouth ulceration, nail disorder, neck pain, neoplasm benign, oral moniliasis, otitis externa, photosensitivity reaction, rectal disorder, seborrhea, skin carcinoma, skin discoloration, skin hypertrophy, skin ulcer, stomatitis, tendon disorder, thinking abnormal, tooth caries, sweating, syncope, tachycardia, taste perversion, unintended pregnancy, vaginal moniliasis, vaginitis, valvular heart disease, vasodilatation, and vertigo.

Post-Marketing Events 

The following adverse reactions have been identified during postapproval use of PROTOPIC Ointment. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

CNS

Seizures

Neoplasms

Lymphomas, basal cell carcinoma, squamous cell carcinoma, malignant melanoma

Infections

Bullous impetigo, osteomyelitis, septicemia

Renal

Acute renal failure in patients with or without Netherton’s syndrome, renal impairment

Skin

Rosacea






REPORTS OF SUSPECTED PROTOPIC SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Protopic. The information is not vetted and should not be considered as verified clinical evidence.

Possible Protopic side effects / adverse reactions in 31 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2011-11-02

Patient: 31 year old male weighing 67.0 kg (147.4 pounds)

Reactions: Abdominal Discomfort, Nausea, Headache

Adverse event resulted in: disablity

Suspect drug(s):
Protopic

Other drugs received by patient: Cold Cream; Elocon



Possible Protopic side effects / adverse reactions in 47 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-11-22

Patient: 47 year old female

Reactions: Superinfection, Mycosis Fungoides, Dermatitis Exfoliative, Septic Shock

Adverse event resulted in: death

Suspect drug(s):
Protopic

Other drugs received by patient: Neoral



Possible Protopic side effects / adverse reactions in 12 year old male

Reported by a physician from Portugal on 2011-11-23

Patient: 12 year old male weighing 45.0 kg (99.0 pounds)

Reactions: Dermatitis Atopic, B-Cell Lymphoma, Upper Limb Fracture, Tooth Extraction, Mycosis Fungoides, Condition Aggravated

Suspect drug(s):
Protopic

Other drugs received by patient: Hydroxyzine; Corticosteroids, Dermatological Preparations; Emollients and Protectives



See index of all Protopic side effect reports >>

Drug label data at the top of this Page last updated: 2010-05-24

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