Famvir
- Generic Name: famciclovir
- Brand Name: Famvir
Famvir (Famciclovir) side effects drug center
Famvir Side Effects Center
What Is Famvir?
Famvir (famciclovir) is an antiviral drug used to treat infections caused by herpes viruses, including genital herpes, cold sores, shingles, and chicken pox. Famvir is available in generic form.
What Are Side Effects of Famvir?
Common side effects of Famvir include:
- headache,
- nausea,
- stomach pain,
- gas,
- diarrhea,
- tired feeling,
- dizziness,
- sleepiness,
- itching or skin rash, or
- numbness or tingly feeling.
Tell your doctor if you have serious side effects of Famvir including:
- mental/mood changes (such as agitation, slowed thinking, confusion, hallucinations),
- changes in the amount of urine,
- yellowing eyes or skin, or
- easy bruising or bleeding.
Dosage for Famvir?
Dosing for Famvir varies. The recommended doses are: recurrent genital herpes: 1,000 mg every 12 hours for one day; recurrent cold sores: 1,500 mg as a single dose; suppression of recurrent genital herpes: 250 mg twice daily; shingles: 500 mg every 8 hours for 7 days; and HIV-infected patients (cold sores or genital herpes): 500 mg twice daily for 7 days.
What Drugs, Substances, or Supplements Interact with Famvir?
Before taking Famvir, tell your doctor if you are also taking probenecid (Benemid). If you are using probenecid, you may not be able to use Famvir, or you may need dosage adjustments or special tests during treatment.
Famvir During Pregnancy and Breastfeeding
During pregnancy, Famvir should be used only when prescribed. It is not known if this medication passes into breast milk. It may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.
Additional Information
Our Famvir (famciclovir) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Famvir Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- confusion; or
- kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath.
Common side effects may include:
- headache; or
- nausea.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Famvir (Famciclovir)
Famvir Professional Information
SIDE EFFECTS
Acute renal failure is discussed in greater detail in other sections of the label [see WARNINGS AND PRECAUTIONS].
The most common adverse events reported in at least 1 indication by >10% of adult patients treated with FAMVIR are headache and nausea.
Clinical Trials Experience In Adult Patients
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Immunocompetent Patients
The safety of FAMVIR has been evaluated in active-and placebo-controlled clinical studies involving 816 FAMVIR-treated patients with herpes zoster (FAMVIR, 250 mg three times daily to 750 mg three times daily); 163 FAMVIR-treated patients with recurrent genital herpes (FAMVIR, 1000 mg twice daily); 1,197 patients with recurrent genital herpes treated with FAMVIR as suppressive therapy (125 mg once daily to 250 mg three times daily) of which 570 patients received FAMVIR (open-labeled and/or double-blind) for at least 10 months; and 447 FAMVIR-treated patients with herpes labialis (FAMVIR, 1500 mg once daily or 750 mg twice daily). Table 2 lists selected adverse events.
Table 2 Selected Adverse Events (all grades and without regard to causality) Reported by ≥2% of Patients in
Placebo-Controlled Famvir Trials*
| Incidence | ||||||||
| Events | Herpes Zoster† | Recurrent Genital Herpes‡ | Genital Herpes-Suppression§ | Herpes Labialis‡ | ||||
| Famvir (n=273) % |
Placebo (n=146) % |
Famvir (n=163) % |
Placebo (n=166) % |
Famvir (n=458) % |
Placebo (n=63) % |
Famvir (n=447) % |
Placebo (n=254) % |
|
| Nervous System | ||||||||
| Headache | 22.7 | 17.8 | 13.5 | 5.4 | 39.3 | 42.9 | 8.5 | 6.7 |
| Paresthesia | 2.6 | 0.0 | 0.0 | 0.0 | 0.9 | 0.0 | 0.0 | 0.0 |
| Migraine | 0.7 | 0.7 | 0.6 | 0.6 | 3.1 | 0.0 | 0.2 | 0.0 |
| Gastrointestinal | ||||||||
| Nausea | 12.5 | 11.6 | 2.5 | 3.6 | 7.2 | 9.5 | 2.2 | 3.9 |
| Diarrhea | 7.7 | 4.8 | 4.9 | 1.2 | 9.0 | 9.5 | 1.6 | 0.8 |
| Vomiting | 4.8 | 3.4 | 1.2 | 0.6 | 3.1 | 1.6 | 0.7 | 0.0 |
| Flatulence | 1.5 | 0.7 | 0.6 | 0.0 | 4.8 | 1.6 | 0.2 | 0.0 |
| Abdominal Pain | 1.1 | 3.4 | 0.0 | 1.2 | 7.9 | 7.9 | 0.2 | 0.4 |
| Body as a Whole | ||||||||
| Fatigue | 4.4 | 3.4 | 0.6 | 0.0 | 4.8 | 3.2 | 1.6 | 0.4 |
| Skin and Appendages | ||||||||
| Pruritus | 3.7 | 2.7 | 0.0 | 0.6 | 2.2 | 0.0 | 0.0 | 0.0 |
| Rash | 0.4 | 0.7 | 0.0 | 0.0 | 3.3 | 1.6 | 0.0 | 0.0 |
| Reproductive (Female) | ||||||||
| Dysmenorrhea | 0.0 | 0.7 | 1.8 | 0.6 | 7.6 | 6.3 | 0.4 | 0.0 |
| *Patients may have entered into more than one clinical trial. †7 days of treatment ‡1 day of treatment §daily treatment |
||||||||
Table 3 lists selected laboratory abnormalities in genital herpes suppression trials.
Table 3 Selected Laboratory Abnormalities in Genital Herpes Suppression Studies*
| Parameter | Famvir (n=660)† % |
Placebo (n=210)† % |
| Anemia (<0.8 x NRL) | 0.1 | 0.0 |
| Leukopenia (<0.75 x NRL) | 1.3 | 0.9 |
| Neutropenia (<0.8 x NRL) | 3.2 | 1.5 |
| AST (SGOT) (>2 x NRH) | 2.3 | 1.2 |
| ALT (SGPT) (>2 x NRH) | 3.2 | 1.5 |
| Total Bilirubin (>1.5 x NRH) | 1.9 | 1.2 |
| Serum Creatinine (>1.5 x NRH) | 0.2 | 0.3 |
| Amylase (>1.5 x NRH) | 1.5 | 1.9 |
| Lipase (>1.5 x NRH) | 4.9 | 4.7 |
| *Percentage of patients with laboratory abnormalities that were increased or decreased from baseline and were outside of specified ranges. †n values represent the minimum number of patients assessed for each laboratory parameter. NRH=Normal Range High. NRL=Normal Range Low. |
||
HIV-Infected Patients
In HIV-infected patients, the most frequently reported adverse events for FAMVIR (500 mg twice daily; n=150) and acyclovir (400 mg, 5x/day; n=143), respectively, were headache (17% vs. 15%), nausea (11% vs. 13%), diarrhea (7% vs. 11%), vomiting (5% vs. 4%), fatigue (4% vs. 2%), and abdominal pain (3% vs. 6%).
Postmarketing Experience
The adverse events listed below have been reported during postapproval use of FAMVIR. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
Blood and lymphatic system disorders: Thrombocytopenia
Hepatobiliary disorders: Abnormal liver function tests, cholestatic jaundice
Immune system disorders: Anaphylactic shock, anaphylactic reaction
Nervous system disorders: Dizziness, somnolence, seizure
Psychiatric disorders: Confusion (including delirium, disorientation, and confusional state occurring predominantly in the elderly), hallucinations
Skin and subcutaneous tissue disorders: Urticaria, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema (e.g., face, eyelid, periorbital, and pharyngeal edema), hypersensitivity vasculitis
Cardiac disorders: Palpitations
Read the entire FDA prescribing information for Famvir (Famciclovir)
IMAGES
See Images&Copy; Famvir Patient Information is supplied by Cerner Multum, Inc. and Famvir Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.