Zovirax (Acyclovir Sodium) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Herpes Simplex: Short-Term Administration:   The most frequent adverse events reported during clinical trials of treatment of genital herpes with ZOVIRAX 200 mg administered orally 5 times daily every 4 hours for 10 days were nausea and/or vomiting in 8 of 298 patient treatments (2.7%). Nausea and/or vomiting occurred in 2 of 287 (0.7%) patients who received placebo.

Long-Term Administration:    The most frequent adverse events reported in a clinical trial for the prevention of recurrences with continuous administration of 400 mg (two 200-mg capsules) 2 times daily for 1 year in 586 patients treated with ZOVIRAX were nausea (4.8%) and diarrhea (2.4%). The 589 control patients receiving intermittent treatment of recurrences with ZOVIRAX for 1 year reported diarrhea (2.7%), nausea (2.4%), and headache (2.2%).

Herpes Zoster:   The most frequent adverse event reported during 3 clinical trials of treatment of herpes zoster (shingles) with 800 mg of oral ZOVIRAX 5 times daily for 7 to 10 days in 323 patients was malaise (11.5%). The 323 placebo recipients reported malaise (11.1%).

Chickenpox:   The most frequent adverse event reported during 3 clinical trials of treatment of chickenpox with oral ZOVIRAX at doses of 10 to 20 mg/kg 4 times daily for 5 to 7 days or 800 mg 4 times daily for 5 days in 495 patients was diarrhea (3.2%). The 498 patients receiving placebo reported diarrhea (2.2%).

Observed During Clinical Practice:   In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of ZOVIRAX. 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 either their seriousness, frequency of reporting, potential causal connection to ZOVIRAX, or a combination of these factors.

General:    Anaphylaxis, angioedema, fever, headache, pain, peripheral edema.

Nervous:    Aggressive behavior, agitation, ataxia, coma, confusion, decreased consciousness, delirium, dizziness, dysarthria, encephalopathy, hallucinations, paresthesia, psychosis, seizure, somnolence, tremors and dysarthria. These symptoms may be marked, particularly in older adults or in patients with renal impairment (see PRECAUTIONS).

Digestive:   Diarrhea, gastrointestinal distress, nausea.

Hematologic and Lymphatic:    Anemia, leukocytoclastic vasculitis, leukopenia, lymphadenopathy, thrombocytopenia.

Hepatobiliary Tract and Pancreas:    Elevated liver function tests, hepatitis, hyperbilirubinemia, jaundice.

Musculoskeletal:   Myalgia.

Skin:   Alopecia, erythema multiforme, photosensitive rash, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.

Special Senses:   Visual abnormalities.

Urogenital:   Renal failure, elevated blood urea nitrogen, elevated creatinine, hematuria (see WARNINGS).

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