Acyclovir (Acyclovir) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

The most frequent adverse events reported during clinical trials of treatment of genital herpes with acyclovir 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.

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 acyclovir were nausea (4.8%) and diarrhea (2.4%). The 589 control patients receiving intermittent treatment of recurrences with acyclovir for 1 year reported diarrhea (2.7%), nausea (2.4%), and headache (2.2%).

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

The most frequent adverse event reported during 3 clinical trials of treatment of chickenpox with oral acyclovir 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%).

In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of acyclovir. 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.

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

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

Diarrhea, gastrointestinal distress, nausea.

Anemia, leukocytoclastic vasculitis, leukopenia, lymphadenopathy, thrombocytopenia.

Elevated liver function tests, hepatitis, hyperbilirubinemia, jaundice.

Myalgia.

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

Visual abnormalities.

Renal failure, renal pain (may be associated with renal failure), elevated blood urea nitrogen, elevated creatinine, hematuria (see WARNINGS).

REPORTS OF SUSPECTED ACYCLOVIR SIDE EFFECTS / ADVERSE REACTIONS

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