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Acyclovir (Acyclovir) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Acyclovir and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (349)
Death (45)
Life Threatening Events (32)
Disability (5)

Reports by Reaction Type

Oedema (32)Hepatotoxicity (31)Vomiting (30)Nausea (28)Rash (28)Drug Interaction (25)Malaise (25)Pyrexia (24)Palmar-Plantar Erythrodysaesthesia Syndrome (23)Blood Bilirubin Increased (22)Skin Toxicity (22)Renal Failure Acute (22)

Below are a few examples of reports where side effects / adverse reactions may be related to Acyclovir. For a complete list or a specific selection of reports, please use the links above.

Possible Acyclovir side effects in 61 year old female

Reported by a physician from Germany on 2012-08-27

Patient: 61 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Hepatotoxicity, Presyncope

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Acyclovir
    Dosage: 400 milligram

Allopurinol
    Dosage: 300 milligram

Clopidogrel Bisulfate
    Dosage: 75 milligram
    Indication: Prophylaxis

Dexamethasone
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2011-02-24
    End date: 2011-03-17

Dexamethasone
    Dosage: 40 milligram
    Administration route: Oral
    Start date: 2011-03-10
    End date: 2011-03-17

Enalapril Maleate
    Dosage: 10 milligram

Pantoprazole
    Dosage: 40 milligram

Revlimid
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2011-02-24
    End date: 2011-03-16

Torsemide
    Dosage: 10 milligram
    Indication: Hypertension

Other drugs received by patient: Amitriptyline HCL; Trimethoprim + Sulfamethoxazole; Valoron; Amitriptyline Hydrochloride; Lyrica; Enoxaparin Sodium; Moviprep; Soventol Gel; Folsan; Morphine; Morphine; Valoron; Cotrim DS



Possible Acyclovir side effects in female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-23

Patient: female

Reactions: Agitation, Self Injurious Behaviour

Drug(s) suspected as cause:
Acyclovir
    Indication: Product Used FOR Unknown Indication

Lormetazepam
    Indication: Product Used FOR Unknown Indication



Possible Acyclovir side effects in female

Reported by a pharmacist from France on 2012-08-22

Patient: female

Reactions: Ear Discomfort, Deafness

Drug(s) suspected as cause:
Acyclovir



Possible Acyclovir side effects in female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-22

Patient: female

Reactions: Self Injurious Behaviour, Nervousness

Drug(s) suspected as cause:
Acyclovir
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Lormetazepam
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Acyclovir side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-08-21

Patient: 61 year old female

Reactions: Neurotoxicity, Dysarthria, Psychotic Disorder, Hallucination, Visual

Drug(s) suspected as cause:
Acyclovir



Possible Acyclovir side effects in 66 year old male

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-08-21

Patient: 66 year old male

Reactions: Dysarthria, Neurotoxicity, Depressed Level of Consciousness

Drug(s) suspected as cause:
Acyclovir
    Dosage: 400 mg, bid

Acyclovir
    Dosage: 200 mg, daily
    Indication: Herpes Zoster

Valacyclovir Hydrochloride
    Dosage: 500 mg, bid
    Administration route: Oral
    Indication: Herpes Zoster



Possible Acyclovir side effects in 73 year old female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 73 year old female, weighing 90.7 kg (199.6 pounds)

Reactions: Incoherent, Renal Failure, Hallucination, Blood Pressure Decreased, Hypersomnia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acyclovir

Other drugs received by patient: Adderall; Wellbutrin SR



Possible Acyclovir side effects in female

Reported by a physician from Italy on 2012-08-20

Patient: female

Reactions: Suicidal Behaviour, Mental Disorder

Drug(s) suspected as cause:
Acyclovir
    Dosage: 2400 milligram daily;
    Administration route: Oral
    Start date: 2012-06-27
    End date: 2012-06-27

Aspirin
    Dosage: 2500 milligram daily;
    Administration route: Oral
    Start date: 2012-06-27
    End date: 2012-06-27

Minias
    Dosage: exact drop number taken is unknown
    Administration route: Oral
    Start date: 2012-06-27
    End date: 2012-06-27



Possible Acyclovir side effects in 57 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16

Patient: 57 year old female, weighing 60.3 kg (132.7 pounds)

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Acyclovir
    Dosage: 1 tab 3 times a day po days
    Administration route: Oral
    Indication: Oral Herpes
    Start date: 2012-08-11
    End date: 2012-08-11

Acyclovir
    Dosage: 1 tab 3 times a day po days
    Administration route: Oral
    Indication: Oral Herpes
    Start date: 2012-07-17
    End date: 2012-07-19



Possible Acyclovir side effects in 46 year old female

Reported by a pharmacist from United States on 2012-08-16

Patient: 46 year old female, weighing 111.0 kg (244.2 pounds)

Reactions: Drug Prescribing Error, Renal Failure Acute

Drug(s) suspected as cause:
Acyclovir



Possible Acyclovir side effects in 32 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-16

Patient: 32 year old female, weighing 68.0 kg (149.6 pounds)

Reactions: Abortion Missed, Pregnancy

Adverse event resulted in: death

Drug(s) suspected as cause:
Acyclovir
    Dosage: 800 mg
    Administration route: Oral
    Indication: Antiviral Prophylaxis
    Start date: 2003-04-29

Combivir
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2003-05-29

Efavirenz
    Dosage: 600 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2003-05-29

Septra
    Dosage: 480 mg, qd
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    Start date: 2003-04-29
    End date: 2009-08-04



Possible Acyclovir side effects in

Reported by a physician from Germany on 2012-08-15

Patient:

Reactions: Fungal Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Acyclovir
    Indication: Antiviral Prophylaxis

Revlimid
    Administration route: Oral
    Indication: Multiple Myeloma

Other drugs received by patient: Ciprofloxacin; Fluconazole; Posaconazole



Possible Acyclovir side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: female, weighing 98.9 kg (217.5 pounds)

Reactions: Nausea, Headache, Product Physical Issue

Drug(s) suspected as cause:
Acyclovir



Possible Acyclovir side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-08-14

Patient: 61 year old female

Reactions: Dysarthria, Neurotoxicity, Psychotic Disorder, Hallucination, Visual

Drug(s) suspected as cause:
Acyclovir



Possible Acyclovir side effects in 29 year old male

Reported by a physician from Singapore on 2012-08-13

Patient: 29 year old male

Reactions: Angioedema, Anaphylactic Reaction, Urticaria, Hypotension

Drug(s) suspected as cause:
Acyclovir
    Indication: Product Used FOR Unknown Indication

Ceftriaxone
    Indication: Product Used FOR Unknown Indication

Flagyl
    Indication: Product Used FOR Unknown Indication

Toradol
    Indication: Product Used FOR Unknown Indication



Possible Acyclovir side effects in 63 year old female

Reported by a health professional (non-physician/pharmacist) from Hong Kong on 2012-08-09

Patient: 63 year old female

Reactions: Blood Pressure Increased, Haemoglobin Decreased, Toxic Encephalopathy, Haemodialysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acyclovir
    Dosage: (400 mg qid oral)
    Administration route: Oral
    Indication: Herpes Zoster

Acyclovir
    Dosage: (5 % 5x/day topical)
    Administration route: Topical
    Indication: Herpes Zoster

Other drugs received by patient: Aspirin; Metoprolol Tartrate; Alfacalcidol; Calcium Carbonate; Epogen; Diltiazem HCL



Possible Acyclovir side effects in 87 year old male

Reported by a pharmacist from United States on 2012-08-09

Patient: 87 year old male, weighing 75.0 kg (165.0 pounds)

Reactions: Blood Urea Increased, Blood Creatinine Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acyclovir



Possible Acyclovir side effects in 68 year old female

Reported by a physician from United Kingdom on 2012-08-09

Patient: 68 year old female

Reactions: Liver Function Test Abnormal

Drug(s) suspected as cause:
Acyclovir
    Administration route: Oral
    Indication: Oral Herpes
    Start date: 2012-03-15
    End date: 2012-03-22

Fluconazole
    Administration route: Oral
    Indication: Candidiasis
    Start date: 2012-03-15
    End date: 2012-03-22

Omeprazole
    Administration route: Oral
    Indication: Gastric Disorder
    Start date: 2012-03-15

Velcade
    Indication: Chemotherapy
    Start date: 2012-03-15

Other drugs received by patient: Dexamethasone Sodium Phosphate; Oxycodone HCL; Calceos; Moviprep; Allopurinol



Possible Acyclovir side effects in 71 year old female

Reported by a physician from Germany on 2012-08-08

Patient: 71 year old female

Reactions: Exfoliative Rash

Drug(s) suspected as cause:
Acyclovir
    Dosage: 800 milligram
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2011-05-20
    End date: 2011-05-31

Cotrim DS
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2011-05-20
    End date: 2011-05-31

Dexamethasone
    Dosage: 40 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2011-05-20

Revlimid
    Dosage: 25 milligram
    Administration route: Oral
    End date: 2011-06-28

Revlimid
    Dosage: 25 milligram
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2011-05-20
    End date: 2011-06-03

Other drugs received by patient: Polyethylene Glycol; Enoxaparin Sodium; Morphine; Metamizole



Possible Acyclovir side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: male

Reactions: Asthma, Headache, Gastric Ulcer, Fatigue, Neuropathy Peripheral, Depression, Myocardial Infarction, Pneumonia, Haemorrhoids, Acquired Immunodeficiency Syndrome, Hernia, Cerebrovascular Accident, Cushing's Syndrome, Bronchitis Chronic, Epididymitis, Cardiac Arrest

Drug(s) suspected as cause:
Acyclovir

Albuterol Sulfate and Ipratropium Bromide
    Dosage: 3/5 mg three times a day

Aspirin

Bupropion Hydrochloride

Bystolic

Crestor
    Administration route: Oral

Fluorouracil
    Dosage: every 12 hours

Folic Acid

Fosamax

Isentress

Lasix
    Dosage: 40 mg daily and as needed

MAG Oxide Cypress

Multi-Vitamin
    Dosage: daily

Neurontin
    Dosage: 300 mg three times a day as needed

Norvir

Oxegen
    Dosage: 2 liters while sleeping and as needed

Plavix

Prezista

Prilosec
    Administration route: Oral

Prochlorperazine

Spironolactone

Testosterone

Vitamin D



Possible Acyclovir side effects in 87 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-08

Patient: 87 year old male

Reactions: Diarrhoea, Bone Lesion, Conjunctivitis Infective, Skin Lesion, Keratitis Viral, Erythema, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acyclovir
    Dosage: 10 mg/kg, 3x/day
    Indication: Herpes Zoster Ophthalmic
    Start date: 2012-05-06
    End date: 2012-05-09

Lasix
    Dosage: 40 mg, 2x/day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-05-09

Pyostacine
    Dosage: unk
    Administration route: Oral
    Indication: Skin Lesion
    Start date: 2012-05-06

Ramipril
    Dosage: 2.5 mg, daily
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-05-09

Other drugs received by patient: Bisoprolol; Valaciclovir; Tobrex; NEO-Mercazole TAB; Previscan; Allopurinol; Potassium Chloride; Zovirax



Possible Acyclovir side effects in 59 year old male

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-08-08

Patient: 59 year old male

Reactions: Fungaemia, Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acyclovir
    Dosage: 1600 mg

Cotrim

Cyclosporine

Levofloxacin
    Dosage: 500 mg
    Administration route: Oral
    Indication: Pneumonia

Prednisone TAB

Voriconazole
    Dosage: 400 mg
    Administration route: Oral
    Indication: Prophylaxis



Possible Acyclovir side effects in 80 year old male

Reported by a health professional (non-physician/pharmacist) from Hong Kong on 2012-08-08

Patient: 80 year old male

Reactions: Dyspnoea, Malaise, Vomiting, Dehydration, Encephalitis, Mental Status Changes, General Physical Health Deterioration, Stupor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acyclovir

Other drugs received by patient: Aspirin; Chloramphenicol; Allopurinol; Chlorpheniramine Maleate; Isosorbide Dinitrate



Possible Acyclovir side effects in 73 year old male

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: 73 year old male

Reactions: Dysphagia, International Normalised Ratio Increased, General Physical Health Deterioration, Erosive Oesophagitis, Rash, International Normalised Ratio Fluctuation

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Acyclovir
    Indication: Herpes Simplex
    Start date: 2012-06-07
    End date: 2012-06-18

Clindamycin
    Indication: Herpes Simplex
    Start date: 2012-06-07
    End date: 2012-06-18

Coumadin
    Dosage: 7.5mg unknown
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-07

Valtrex
    Dosage: 500mg twice per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-17
    End date: 2012-06-23

Other drugs received by patient: Zovirax; Digoxin; Prednisone TAB; Bactroban; Amiodarone HCL; Omeprazole



Possible Acyclovir side effects in 45 year old male

Reported by a physician from United States on 2012-08-08

Patient: 45 year old male

Reactions: Electrocardiogram QT Prolonged, Febrile Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acyclovir
    Indication: Prophylaxis

Cytarabine
    Dosage: 200 mg/m2, cyclic, (total dose 43.02 mg)
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-12-24

Cytarabine
    Dosage: 200 mg/m2, cyclic, (total dose 44.46 g)
    Start date: 2012-05-30

Daunorubicin HCL
    Dosage: 60 mg/m2, cyclic, (total 5 courses of therapy)
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-12-24

Fluconazole
    Indication: Prophylaxis

Piperacillin
    Indication: Prophylaxis

Sprycel
    Dosage: 50 mg, cyclic, (total dose 1800 mg)
    Start date: 2012-03-19

Sprycel
    Dosage: 100 mg, cyclic, (total dose 2100 mg)
    Start date: 2012-05-30

Sprycel
    Dosage: 100 mg, cyclic
    Administration route: Oral
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-12-24



Possible Acyclovir side effects in 63 year old female

Reported by a health professional (non-physician/pharmacist) from Hong Kong on 2012-08-08

Patient: 63 year old female

Reactions: Haemoglobin Decreased, Blood Pressure Increased, Toxic Encephalopathy, Mental Status Changes, Stupor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acyclovir
    Dosage: 400 mg / four times per day / oral
    Administration route: Oral
    Indication: Herpes Zoster

Zovirax
    Dosage: fve times per day / topical
    Administration route: Topical
    Indication: Herpes Zoster

Other drugs received by patient: Metoprolol Tartrate; Alfacalcidol; Diltiazem HCL; Epogen; Aspirin; Calcium Carbonate



Possible Acyclovir side effects in male

Reported by a physician from Italy on 2012-08-07

Patient: male

Reactions: Confusional State, Overdose, Hypokinesia, Ataxia, Bradyphrenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acyclovir

Other drugs received by patient: Coumadin; Cordarone; Altiazem; Zantac; Calcium Carbonate; Leucovorin Calcium; Valium



Possible Acyclovir side effects in 68 year old female

Reported by a individual with unspecified qualification on 2012-08-07

Patient: 68 year old female

Reactions: Blood Alkaline Phosphatase Increased, Alanine Aminotransferase Increased, Protein Total Increased

Drug(s) suspected as cause:
Acyclovir
    Dosage: 400 mg, oral
    Administration route: Oral
    Indication: Oral Herpes
    Start date: 2012-03-15
    End date: 2012-03-22

Fluconazole
    Dosage: 50 mg, oral
    Administration route: Oral
    Indication: Candidiasis
    Start date: 2012-03-15
    End date: 2012-03-22

Omeprazole
    Dosage: 20 mg, oral
    Administration route: Oral
    Indication: Gastric Disorder
    Start date: 2012-03-15

Velcade
    Dosage: intravenous
    Indication: Chemotherapy

Other drugs received by patient: Oxycodone HCL; Allopurinol; Dexamethasone Sodium Phosphate; Movicol (Nulytely / 01053601 / ); Calceos (Lekovit CA)



Possible Acyclovir side effects in female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-07

Patient: female

Reactions: Abdominal Pain, Haematemesis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acyclovir



Possible Acyclovir side effects in male

Reported by a physician from Italy on 2012-08-07

Patient: male

Reactions: Confusional State, Blood Urea Increased, Bradykinesia, Ataxia, Hypokinesia, Overdose, Blood Creatinine Increased, Bradyphrenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acyclovir

Other drugs received by patient: Zantac; Cordarone; Valium; Calcium Carbonate; Altiazem; Coumadin; Leucovorin Calcium

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