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Acyclovir (Acyclovir) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The adverse reactions listed below have been observed in controlled and uncontrolled clinical trials in approximately 700 patients who received acyclovir at ~5 mg/kg (250 mg/m2) 3 times daily, and approximately 300 patients who received ~10 mg/kg (500 mg/m2) 3 times daily.

The most frequent adverse reactions reported during administration of acyclovir were inflammation or phlebitis at the injection site in approximately 9% of the patients, and transient elevations of serum creatinine or BUN in 5% to 10% (the higher incidence occurred usually following rapid [less than 10 minutes] intravenous infusion). Nausea and/or vomiting occurred in approximately 7% of the patients (the majority occurring in nonhospitalized patients who received 10 mg/kg). Itching, rash, or hives occurred in approximately 2% of patients. Elevation of transaminases occurred in 1% to 2% of patients.

The following hematologic abnormalities occurred at a frequency of less than 1%: anemia, neutropenia, thrombocytopenia, thrombocytosis, leukocytosis, and neutrophilia. In addition, anorexia and hematuria were observed.

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 injection in clinical practice. 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 acyclovir or a combination of these factors.

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

Digestive: Abdominal pain, diarrhea, gastrointestinal distress, nausea.

Cardiovascular: Hypotension.

Hematologic and Lymphatic: Disseminated intravascular coagulation, hemolysis, leukocytoclastic vasculitis, leukopenia, lymphadenopathy.

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

Musculoskeletal: Myalgia.

Nervous: Aggressive behavior, agitation, ataxia, coma, confusion, delirium, dizziness, dysarthria, encephalopathy, hallucinations, obtundation, paresthesia, psychosis, seizure, somnolence, tremor. These symptoms may be marked, particularly in older adults (see PRECAUTIONS).

Skin: Alopecia, erythema multiforme, photosensitive rash, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria. Severe local inflammatory reactions, including tissue necrosis, have occurred following infusion of acyclovir into extravascular tissues.

Special Senses: Visual abnormalities.

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



REPORTS OF SUSPECTED ACYCLOVIR SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Acyclovir side effects / adverse reactions in 34 year old female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2011-10-03

Patient: 34 year old female weighing 65.5 kg (144.1 pounds)

Reactions: Drug Interaction, Sinus Tachycardia, Sinoatrial Block, Sinus Bradycardia

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Noxafil
    Dosage: 400 mg milligram(s), 1 day, oral
    Administration route: Oral
    Indication: Hepatosplenic Candidiasis
    Start date: 2007-10-19
    End date: 2008-01-25

Etoposide
    Indication: Product Used FOR Unknown Indication

Acyclovir
    Dosage: 200 mg milligram(s), oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Ondansetron
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-01-22
    End date: 2008-01-25

Vogalene
    Indication: Product Used FOR Unknown Indication

Allopurinol
    Dosage: 100 mg milligram(s), oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Cytarabine
    Indication: Product Used FOR Unknown Indication

Pantoloc /01263204/)
    Dosage: 40 mg milligram(s)
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-01-22
    End date: 2008-01-25

Potassium Chloride
    Dosage: 750 mg milligram(s), oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Acyclovir side effects / adverse reactions in 50 year old male

Reported by a health professional (non-physician/pharmacist) from Spain on 2011-10-05

Patient: 50 year old male

Reactions: Hepatotoxicity, Transaminases Increased

Suspect drug(s):
Amikacin
    Indication: Febrile Neutropenia
    Start date: 2011-04-17
    End date: 2011-04-20

Teicoplanin
    Indication: Febrile Neutropenia
    Start date: 2011-04-08
    End date: 2011-04-15

Teicoplanin
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-04-08
    End date: 2011-04-15

Cancidas
    Indication: Febrile Neutropenia
    Start date: 2011-04-10
    End date: 2011-04-20

Acyclovir
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-04-13
    End date: 2011-04-17

Meropenem
    Indication: Febrile Neutropenia
    Start date: 2011-03-23
    End date: 2011-04-22

Amikacin
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-04-17
    End date: 2011-04-20

Acyclovir
    Indication: Febrile Neutropenia
    Start date: 2011-04-13
    End date: 2011-04-17

Meropenem
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-03-23
    End date: 2011-04-22



Possible Acyclovir side effects / adverse reactions in 34 year old female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2011-10-06

Patient: 34 year old female weighing 65.6 kg (144.3 pounds)

Reactions: Nodal Arrhythmia, Drug Interaction, Sinus Bradycardia, Atrioventricular Block Second Degree

Adverse event resulted in: life threatening event

Suspect drug(s):
Acyclovir
    Dosage: 200 mg, oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Cytarabine
    Indication: Product Used FOR Unknown Indication

Etoposide
    Indication: Product Used FOR Unknown Indication

Allopurinol
    Dosage: 100 mg, oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Vogalene (Metopimazine) (Metopimazine)
    Indication: Product Used FOR Unknown Indication

Pantoprazole Sodium
    Dosage: 40 mg,
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-01-22
    End date: 2008-01-25

Ondansetron
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-01-22
    End date: 2008-01-25

Potassium Chloride
    Dosage: 750 mg, oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Noxafil
    Dosage: 40 mg, oral suspension 4 x per day, oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



See index of all Acyclovir side effect reports >>

Drug label data at the top of this Page last updated: 2006-01-03

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