DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Locoid Lipocream (Hydrocortisone Butyrate Topical) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • HPA axis suppression. This has been observed in pediatric subjects using Locoid Lipocream [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)]
  • Concomitant skin infections [see Warnings and Precautions (5.2)]
  • Skin irritation [see Warnings and Precautions (5.3)]

Clinical Trials Experience: Adults

The following additional local adverse reactions have been reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, drying, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

Clinical Trials Experience: Pediatrics

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety data derived from Locoid Lipocream clinical trials reflect exposure to Locoid Lipocream twice daily for up to four weeks in separate clinical trials involving pediatric subjects 3 months to 18 years of age with mild to moderate atopic dermatitis.

Adverse reactions shown in the tables below include those for which there is some basis to believe there is a causal relationship to Locoid Lipocream.

Table 1. Frequency of adverse reactions in pediatric subjects with mild to moderate atopic dermatitis
Locoid Lipocream
(N=131)
Vehicle
(N=133)
Application site reactions, including application site folliculitis, irritation, dermatitis, or erythema 1.5% 1.5%
Acne 0.8% 0.0%
Telangiectasia 0.0% 0.8%

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Locoid Lipocream. 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.

Skin:  Erythema, Rash and Application site irritation.



REPORTS OF SUSPECTED LOCOID LIPOCREAM SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Locoid Lipocream side effects / adverse reactions in 77 year old male

Reported by a consumer/non-health professional from United States on 2012-01-24

Patient: 77 year old male

Reactions: Application Site Bleeding, Application Site Pain, Application Site Erythema

Suspect drug(s):
Locoid Lipocream



Possible Locoid Lipocream side effects / adverse reactions in 77 year old male

Reported by a consumer/non-health professional from United States on 2012-02-07

Patient: 77 year old male

Reactions: Application Site Bleeding, Application Site Swelling, Application Site Pain, Application Site Erythema, Gait Disturbance

Suspect drug(s):
Locoid Lipocream



Possible Locoid Lipocream side effects / adverse reactions in 55 year old female

Reported by a physician from United States on 2012-03-29

Patient: 55 year old female

Reactions: Application Site Warmth, Drug Ineffective, Basal Cell Carcinoma, Application Site Swelling, Application Site Burn, Application Site Erythema

Suspect drug(s):
Locoid Lipocream
    Dosage: bid, topically
    Administration route: Topical
    Indication: Blepharitis
    Start date: 2011-01-27
    End date: 2011-01-01

Locoid Lipocream
    Dosage: apply every other week, alternating with promiseb, topically
    Administration route: Topical
    Indication: Dermatitis
    Start date: 2011-06-01
    End date: 2011-07-12

Locoid Lipocream
    Dosage: topically
    Administration route: Topical
    Indication: Blepharitis
    Start date: 2011-06-13
    End date: 2011-01-01

Locoid Lipocream
    Dosage: apply every other week, alternating with locoid lipocream, topically
    Administration route: Topical
    Indication: Dermatitis
    Start date: 2011-01-01
    End date: 2011-07-01

Xolegel
    Dosage: topically
    Indication: Blepharitis
    Start date: 2011-07-14

Other drugs received by patient: Topamax



See index of all Locoid Lipocream side effect reports >>

Drug label data at the top of this Page last updated: 2013-09-01

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017