Zovirax (Acyclovir Sodium) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

In 5 double-blind, placebo-controlled trials, 1,124 patients were treated with ZOVIRAX Cream and 1,161 with placebo (vehicle) cream. ZOVIRAX Cream was well tolerated; 5% of patients on ZOVIRAX Cream and 4% of patients on placebo reported local application site reactions.

The most common adverse reactions at the site of topical application were dry lips, desquamation, dryness of skin, cracked lips, burning skin, pruritus, flakiness of skin, and stinging on skin; each event occurred in less than 1% of patients receiving ZOVIRAX Cream and vehicle. Three patients on ZOVIRAX Cream and 1 patient on placebo discontinued treatment due to an adverse event.

An additional study, enrolling 22 healthy adults, was conducted to evaluate the dermal tolerance of ZOVIRAX Cream compared with vehicle using single occluded and semi-occluded patch testing methodology. Both ZOVIRAX Cream and vehicle showed a high and cumulative irritation potential. Another study, enrolling 251 healthy adults, was conducted to evaluate the contact sensitization potential of ZOVIRAX Cream using repeat insult patch testing methodology. Of 202 evaluable subjects, possible cutaneous sensitization reactions were observed in the same 4 (2%) subjects with both ZOVIRAX Cream and vehicle, and these reactions to both ZOVIRAX Cream and vehicle were confirmed in 3 subjects upon rechallenge. The sensitizing ingredient(s) has not been identified.

The safety profile in patients 12 to 17 years of age was similar to that observed in adults.

Observed During Clinical Practice:

In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of acyclovir cream. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to acyclovir cream.

General:

Angioedema, anaphylaxis.

Skin:

Contact dermatitis, eczema, application site reactions including signs and symptoms of inflammation.

REPORTS OF SUSPECTED ZOVIRAX SIDE EFFECTS / ADVERSE REACTIONS

Possible Zovirax side effects / adverse reactions in 1 year old female

Reported by a physician from Japan on 2011-10-04

Patient: 1 year old female

Reactions: Agranulocytosis, Rash

Suspect drug(s):
Zovirax

Other drugs received by patient: Flomox

Possible Zovirax side effects / adverse reactions in 12 month old female

Reported by a physician from Japan on 2011-10-11

Patient: 12 month old female

Reactions: Agranulocytosis

Suspect drug(s):
Zovirax

Other drugs received by patient: Flomox

Possible Zovirax side effects / adverse reactions in 66 year old male

Reported by a physician from Japan on 2011-10-24

Patient: 66 year old male

Reactions: Pneumonia, Interstitial Lung Disease

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Cytarabine
    Dosage: 40 mg, daily
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-11-18
    End date: 2010-11-18

Sulfamethoxazole
    Dosage: 1 df, 1x/day
    Administration route: Oral
    Start date: 2011-07-15

Zovirax
    Dosage: 200 mg, 1x/day
    Administration route: Oral
    Start date: 2011-07-12
    End date: 2011-07-19

Meropenem
    Dosage: 1 g, 3x/day
    Start date: 2011-07-04
    End date: 2011-07-15

Doxorubicin Hydrochloride
    Dosage: 30 mg/m2, unk
    Start date: 2010-11-24
    End date: 2010-11-24

Sulfamethoxazole
    Dosage: 1 df, 1x/day
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    End date: 2011-01-28

Allopurinol
    Dosage: 100 mg, 3x/day
    Administration route: Oral
    Start date: 2011-07-05
    End date: 2011-07-19

Fentanyl
    Dosage: unk
    Indication: Stomatitis
    Start date: 2011-01-02
    End date: 2011-01-19

Magmitt
    Dosage: unk
    Administration route: Oral
    Indication: Constipation
    Start date: 2011-01-07
    End date: 2011-01-10

Prednisolone
    Dosage: 10 mg, daily
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-11-18
    End date: 2010-11-18

Lansoprazole
    Dosage: 15 mg, 1x/day
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    End date: 2011-02-17

Cefazolin Sodium
    Dosage: unk
    Administration route: Oral
    Indication: Proctitis
    Start date: 2010-10-22
    End date: 2011-02-17

Baraclude
    Dosage: 0.5 mg, 1/2day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2010-06-29
    End date: 2011-07-19

Oncovin
    Dosage: 1 mg/m2, unk
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-07
    End date: 2010-12-22

Cymerin
    Dosage: 60 mg/m2, unk
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-14
    End date: 2010-12-29

Etoposide
    Dosage: 100 mg/m2, 3x/day
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-26
    End date: 2010-12-08

Allopurinol
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Indication: Hyperuricaemia
    End date: 2011-01-20

Pantosin
    Dosage: unk
    Administration route: Oral
    Indication: Constipation
    Start date: 2011-01-07
    End date: 2011-01-10

Doxorubicin Hydrochloride
    Dosage: 30 mg/m2, unk
    Start date: 2010-12-29
    End date: 2010-12-29

Prednisolone
    Dosage: 40 mg/m2, unk
    Administration route: Oral
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-07
    End date: 2010-12-29

Fildesin
    Dosage: 2.4 mg/m2, unk
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-26
    End date: 2010-12-08

Doxorubicin Hydrochloride
    Dosage: 30 mg/m2, unk
    Start date: 2010-10-14
    End date: 2010-10-14

Doxorubicin Hydrochloride
    Dosage: 40 mg/m2, unk
    Start date: 2010-12-22
    End date: 2010-12-22

Methotrexate Sodium
    Dosage: 15 mg, daily
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-11-18
    End date: 2010-11-18

Amlodipine
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-10-08
    End date: 2011-02-17

Diflucan
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    End date: 2011-01-11

KW-0761
    Dosage: 1 mg/kg, unk
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-08
    End date: 2010-12-21

Cyclophosphamide
    Dosage: 350 mg/m2, unk
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-07
    End date: 2010-12-22

Lansoprazole
    Dosage: 15 mg, 1x/day
    Administration route: Oral
    Start date: 2011-05-26
    End date: 2011-07-19

Doxorubicin Hydrochloride
    Dosage: 40 mg/m2, unk
    Start date: 2010-11-16
    End date: 2010-11-16

Diflucan
    Dosage: unk
    Start date: 2011-01-19
    End date: 2011-01-28

Vancomycin
    Dosage: 0.5 g, 2x/day
    Start date: 2011-01-07
    End date: 2011-01-17

Lyrica
    Dosage: 75 mg, 1x/day
    Administration route: Oral
    Indication: Pain
    Start date: 2011-06-29
    End date: 2011-07-19

Carboplatin
    Dosage: 250 mg/m2, unk
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-26
    End date: 2010-12-08

Zovirax
    Dosage: unk
    Start date: 2011-06-30
    End date: 2011-07-08

Lipidil
    Dosage: 100 df, 1x/day
    Administration route: Oral
    Indication: Hyperlipidaemia
    End date: 2011-01-26

Meropenem
    Dosage: 0.5 g, 2x/day
    Indication: Pneumonia
    Start date: 2011-01-07
    End date: 2011-01-24

Doxorubicin Hydrochloride
    Dosage: 40 mg/m2, unk
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-07
    End date: 2010-10-07

Zovirax
    Dosage: 200 mg, 1x/day
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2011-01-28

Other drugs received by patient: Ciprofloxacin HCL; Vfend; Slow-K; Targocid