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Altabax (Retapamulin) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical Studies Experience

The safety profile of ALTABAX was assessed in 2,115 adult and pediatric patients ≥9 months who used at least one dose from a 5-day, twice a day regimen of retapamulin ointment. Control groups included 819 adult and pediatric patients who used at least one dose of the active control (oral cephalexin), 172 patients who used an active topical comparator (not available in the US), and 71 patients who used placebo.

Adverse events rated by investigators as drug-related occurred in 5.5% (116/2,115) of patients treated with retapamulin ointment, 6.6% (54/819) of patients receiving cephalexin, and 2.8% (2/71) of patients receiving placebo. The most common drug-related adverse events (≥1% of patients) were application site irritation (1.4%) in the retapamulin group, diarrhea (1.7%) in the cephalexin group, and application site pruritus (1.4%) and application site paresthesia (1.4%) in the placebo group.

Because clinical studies are conducted under varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The adverse reaction information from the clinical studies does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Adults

The adverse events, regardless of attribution, reported in at least 1% of adults (18 years of age and older) who received ALTABAX are listed in Table 1.

Table 1. Adverse Events Reported by ≥1% of Adult Patients Treated With ALTABAX in Phase 3 Clinical Studies

Adverse Event

ALTABAX

N = 1,527

%

Cephalexin

N = 698

%

Headache

2.0

2.0

Application site irritation

1.6

<1.0

Diarrhea

1.4

2.3

Nausea

1.2

1.9

Nasopharyngitis

1.2

<1.0

Creatinine phosphokinase increased

<1.0

1.0

Pediatrics

The adverse events, regardless of attribution, reported in at least 1% of pediatric patients aged 9 months to 17 years who received ALTABAX are listed in Table 2.

Table 2. Adverse Events Reported by≥1% in Pediatric Patients Aged 9 Months to 17 Years Treated With ALTABAX in Phase 3 Clinical Studies

Adverse Event

ALTABAX

N = 588

%

Cephalexin

N = 121

%

Placebo

N = 64

%

Application site pruritus

1.9

0

0

Diarrhea

1.7

5.0

0

Nasopharyngitis

1.5

1.7

0

Pruritus

1.5

1.0

1.6

Eczema

1.0

0

0

Headache

1.2

1.7

0

Pyrexia

1.2

<1.0

1.6

Other Adverse Events

Application site pain, erythema, and contact dermatitis were reported in less than 1% of patients in clinical studies.



REPORTS OF SUSPECTED ALTABAX SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Altabax side effects / adverse reactions in 48 year old female

Reported by a consumer/non-health professional from United States on 2011-11-01

Patient: 48 year old female

Reactions: Oropharyngeal Swelling, Anaphylactic Reaction, Somnolence, Rash Macular, Influenza Like Illness

Suspect drug(s):
Altabax

Other drugs received by patient: Zyrtec



Possible Altabax side effects / adverse reactions in 22 year old female

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: 22 year old female

Reactions: Nasopharyngitis, Drug Ineffective, Skin Exfoliation, Dermatitis, Application Site Pain, Application Site Erythema, Blister

Suspect drug(s):
Altabax

Other drugs received by patient: Rozerem; Lorazepam; Xanax; Vimpat; Baclofen; Keppra; Bactrim; Lamictal; Clobazam; Glycopyrrolate; Dantrium; Unknown Medication; Resparitol



Possible Altabax side effects / adverse reactions in 80 year old female

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: 80 year old female

Reactions: Skin Injury, Product Quality Issue, Pruritus, Swelling Face, Hypersensitivity, Skin Exfoliation, Scab, Pain, Ear Pruritus, Ear Infection, DRY Skin, Periorbital Oedema, Auricular Swelling, Eyelid Function Disorder, Eye Swelling, Ear Injury

Suspect drug(s):
Altabax



See index of all Altabax side effect reports >>

Drug label data at the top of this Page last updated: 2007-05-29

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