Vancomycin Side effects

• Side effects of Vancomycin in details
• Vancomycin contraindications
• Vancomycin reviews

What are the possible side effects of Vancomycin?

Get emergency medical help if you have any of these signs of an allergic reaction to Vancomycin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Certain side effects may occur if your body absorbs Vancomycin through the intestinal walls. Call your doctor at once if you have:

• increased diarrhea that is watery or bloody;

• hearing loss, ringing in your ears;

• kidney problems--swelling, rapid weight gain, pain in your side or lower back, little or no urinating; or

• low potassium--confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling.

Common Vancomycin side effects may include:

• nausea; or

• stomach pain.

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.

Side effects of Vancomycin in details

Clinical Trial Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to Vancomycin hydrochloride in 260 adult subjects in two Phase 3 clinical trials for the treatment of diarrhea associated with C. difficile. In both trials, subjects received Vancomycin hydrochloride capsules 125 mg orally four times daily. The mean duration of treatment was 9.4 days. The median age of patients was 67, ranging between 19 and 96 years of age. Patients were predominantly Caucasian (93%) and 52% were male.

Adverse reactions occurring in ≥ 5% of Vancomycin hydrochloride-treated subjects are shown in Table 1. The most common adverse reactions associated with Vancomycin hydrochloride (≥ 10%) were nausea, abdominal pain, and hypokalemia.

Table 1: Common (≥ 5%) Adverse Reactions*for Vancomycin Hydrochloride Reported in Clinical Trials for Treatment of Diarrhea Associated with C. difficile

* Adverse reaction rates were derived from the incidence of treatment-emergent adverse events.
System/Organ Class	Adverse Reaction	Vancomycin Hydrochloride % (N=260)
Gastrointestinal disorders	Nausea	17
	Abdominal pain	15
	Vomiting	9
	Diarrhea	9
	Flatulence	8
General disorders and administration	Pyrexia	9
site conditions	Edema peripheral	6
	Fatigue	5
Infections and infestations	Urinary tract infection	8
Metabolism and nutrition disorders	Hypokalemia	13
Musculoskeletal and connective tissue disorders	Back pain	6
Nervous system disorders	Headache	7

Nephrotoxicity (e.g., reports of renal failure, renal impairment, blood creatinine increased) occurred in 5% of subjects treated with Vancomycin hydrochloride. Nephrotoxicity following Vancomycin hydrochloride typically first occurred within one week after completion of treatment (median day of onset was Day 16). Nephrotoxicity following Vancomycin hydrochloride occurred in 6% of subjects >65 years of age and 3% of subjects ≤65 years of age.

The incidences of hypokalemia, urinary tract infection, peripheral edema, insomnia, constipation, anemia, depression, vomiting, and hypotension were higher among subjects >65 years of age than in subjects ≤65 years of age.

Discontinuation of study drug due to adverse events occurred in 7% of subjects treated with Vancomycin hydrochloride. The most common adverse events leading to discontinuation of Vancomycin hydrochloride were C. difficile colitis (<1%), nausea (<1%), and vomiting (<1%).

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Vancomycin hydrochloride. Because these reactions 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.

Ototoxicity: Cases of hearing loss associated with intravenously administered Vancomycin have been reported. Most of these patients had kidney dysfunction or a preexisting hearing loss or were receiving concomitant treatment with an ototoxic drug. Vertigo, dizziness, and tinnitus have been reported.

Hematopoietic: Reversible neutropenia, usually starting 1 week or more after onset of intravenous therapy with Vancomycin or after a total dose of more than 25 g, has been reported for several dozen patients. Neutropenia appears to be promptly reversible when Vancomycin is discontinued. Thrombocytopenia has been reported.

Miscellaneous: Patients have been reported to have had anaphylaxis, drug fever, chills, nausea, eosinophilia, rashes (including exfoliative dermatitis), Stevens-Johnson syndrome, toxic epidermal necrolysis, and rare cases of vasculitis in association with the administration of Vancomycin.

A condition has been reported that is similar to the IV–induced syndrome with symptoms consistent with anaphylactoid reactions, including hypotension, wheezing, dyspnea, urticaria, pruritus, flushing of the upper body ("Red Man Syndrome"), pain and muscle spasm of the chest and back. These reactions usually resolve within 20 minutes but may persist for several hours.

What is the most important information I should know about Vancomycin?

• Vancomycin capsules only works against bacteria; it does not treat viral infections (eg, the common cold).
• Long-term or repeated use of Vancomycin capsules may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• Be sure to use Vancomycin capsules for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Kidney problems, including reports of kidney failure, have occurred in patients taking Vancomycin capsules. These kidney problems can occur either during treatment or after treatment is stopped, although they have typically occurred within 1 week after Vancomycin capsules has been stopped. Contact your doctor right away if you experience decreased urination.
• Lab tests, including kidney function tests and hearing tests, may be performed while you use Vancomycin capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Vancomycin capsules with caution in the ELDERLY; they may be more sensitive to its effects.
• Vancomycin capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if Vancomycin capsules can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Vancomycin capsules while you are pregnant. Vancomycin capsules is found in breast milk. Do not breast-feed while taking Vancomycin capsules.

Vancomycin contraindications

Vancomycin Hydrochloride Capsules are contraindicated in patients with known hypersensitivity to Vancomycin.

References

1. European Chemicals Agency - ECHA. "vancomycin: The European Chemicals Agency (ECHA) is an agency of the European Union which is the driving force among regulatory authorities in implementing the EU's groundbreaking chemicals legislation for the benefit of human health and the environment as well as for innovation and competitiveness.". https://echa.europa.eu/ (accessed September 17, 2018).
2. HSDB. "Vancomycin". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
3. NCIt. "Vancomycin: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Vancomycin are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Vancomycin. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology