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Denavir (Penciclovir Sodium) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical Studies

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.

In two double-blind, placebo-controlled trials, 1516 patients were treated with DENAVIR (penciclovir cream) and 1541 with placebo. One or more local adverse reactions were reported by 3% of the patients treated with DENAVIR and 4% of placebo-treated patients. The rates of reported local adverse reactions are shown in Table 1.

Table 1 – Local Adverse Reactions Reported in Phase III Trials
   Penciclovir
n=1516

%
 Placebo
N=1541

%
Applications site reaction
Hypesthesia/Local anesthesia
Taste perversion
Rash (erythematous)

1
<1
<1
<1

2
<1
<1
<1

Two studies, enrolling 108 healthy subjects, were conducted to evaluate the dermal tolerance of 5% penciclovir cream (a 5-fold higher concentration than the commercial formulation) compared to vehicle using repeated occluded patch testing methodology. The 5% penciclovir cream induced mild erythema in approximately one-half of the subjects exposed, an irritancy profile similar to the vehicle control in terms of severity and proportion of subjects with a response. No evidence of sensitization was observed.

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of DENAVIR.  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.

The following events have been identified from worldwide post-marketing use of DENAVIR in treatment of recurrent herpes labialis (cold sores) in adults.  These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to DENAVIR.
General:  Headache, oral/pharyngeal edema, parosmia.
Skin: Aggravated condition, decreased therapeutic response, local edema, pain, paresthesia, pruritus, skin discoloration, and urticaria.



REPORTS OF SUSPECTED DENAVIR SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Denavir side effects / adverse reactions in 64 year old female

Reported by a consumer/non-health professional from United States on 2011-11-08

Patient: 64 year old female weighing 90.7 kg (199.5 pounds)

Reactions: Nasopharyngitis, Coronary Artery Bypass, Expired Drug Administered, Oral Herpes, Sinusitis

Adverse event resulted in: hospitalization

Suspect drug(s):
Denavir

Other drugs received by patient: Lovaza; Vitamin D; Simvastatin



Possible Denavir side effects / adverse reactions in 64 year old female

Reported by a consumer/non-health professional from United States on 2012-02-01

Patient: 64 year old female weighing 90.7 kg (199.5 pounds)

Reactions: Nasopharyngitis, Expired Drug Administered, Oral Herpes, Treatment Noncompliance, Blood Glucose Abnormal, Herpes Zoster, Dermatitis Contact, Coronary Artery Bypass, Chest Pain, Oedema, Gastrooesophageal Reflux Disease, Sinusitis, Musculoskeletal Pain, Post Herpetic Neuralgia, Hypothyroidism, Bronchitis

Adverse event resulted in: hospitalization

Suspect drug(s):
Denavir

Other drugs received by patient: Vitamin D; Benicar HCT; Astepro (Azelastine Hydrochloride); Aspirin LOW (Acetylsalicylic Acid); Metoprolol Tartrate; Simvastatin; Prevacid; Xopenex; Acidophilus (Lactobacillus Acidophilus); Lovaza; Mucinex; Norvasc; Lisinopril + Hidroclorotiazida (Hydrochlorothiazide, Lisinopril)



See index of all Denavir side effect reports >>

Drug label data at the top of this Page last updated: 2013-09-19

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