Over-the-counter medication · Vitamin B7 Supplement
biotin
Also sold as Vitamin B7. This medicine is for people on kidney dialysis.
Data updated 2026-05-15
- 29,879
- FDA reportsModerately reported
- OTC
- Availability
biotin (Vitamin B7) is an over-the-counter Vitamin B7 Supplement. This medicine is for people on kidney dialysis.
Dialyvite with Zinc is a prescription vitamin supplement. It is designed to improve nutrition in people on kidney dialysis.
Verify with FDA → · CMS NADAC pricing →
What it does
This medicine is for people on kidney dialysis.
Common side effects
No common side effects listed.
Key warnings
You should not take this medicine if you are allergic to any of its ingredients.
The sections below are summarized in plain English from biotin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Dialyvite with Zinc provides essential vitamins and minerals. These nutrients help support overall health. It is especially helpful for people with kidney problems.
Side Effects (from patient reports)
Based on 29,879 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for biotin, by number of reports
- Fatigue
Fatigue
3,046 reports
- Nausea
Nausea
2,251 reports
- Alopecia
Alopecia
2,193 reports
- Headache
Headache
2,143 reports
- Diarrhoea
Diarrhoea
1,893 reports
- Pain
Pain
1,703 reports
- Dizziness
Dizziness
1,583 reports
- Arthralgia
Arthralgia
1,426 reports
- Dyspnoea
Dyspnoea
1,404 reports
- Pruritus
Pruritus
1,289 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for biotin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where biotin sits
biotin has more FDA adverse-event reports than 64% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is biotin; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 29,879 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
29,879
Reports Mentioning Death
911
3.0% of reports — not proof of cause
Hospitalization Reports
5,552
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FATIGUE | 3,046 |
| 2 | NAUSEA | 2,251 |
| 3 | ALOPECIA | 2,193 |
| 4 | HEADACHE | 2,143 |
| 6 | DIARRHOEA | 1,893 |
| 7 | PAIN | 1,703 |
| 8 | DIZZINESS | 1,583 |
| 10 | ARTHRALGIA | 1,426 |
| 11 | DYSPNOEA | 1,404 |
| 12 | PRURITUS | 1,289 |
| 13 | FALL | 1,186 |
| 14 | PAIN IN EXTREMITY | 1,074 |
| 15 | ASTHENIA | 1,068 |
| 16 | RASH | 1,042 |
| 17 | COUGH | 977 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
You should not take this medicine if you are allergic to any of its ingredients.
Common Questions
What is Dialyvite with Zinc used for?
How often should I take this medicine?
Can I take this with other medications?
What should I do if I experience side effects?
Is this medicine safe during pregnancy?
What are the ingredients in Dialyvite with Zinc?
How should I store this medicine?
What does 'prescription' mean?
Can I crush or chew the tablet?
What if I accidentally take too much?
What drug class is biotin?
What pregnancy or breastfeeding source fields are listed for biotin?
Related Medications in Vitamin B7 Supplement
Other drugs grouped near biotin - same-class peers and common alternatives.
ascorbic acid
Vitamin C
This medicine is a Vitamin C supplement.
Compare with biotin →
calcitriol
Rocaltrol
Calcitriol is a form of vitamin D that helps your body absorb and use calcium.
Compare with biotin →
calcium carbonate
Tums, Caltrate
Calcium carbonate is a medicine that can relieve heartburn and upset stomach.
Compare with biotin →
cholecalciferol
Vitamin D3
PNV-DHA is a multivitamin with minerals and essential fatty acids.
Compare with biotin →
chromium picolinate
Chromium
Chromium picolinate is a mineral supplement.
Compare with biotin →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for biotin: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 29,879.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 3.05%.
- conjugated estrogens Δ 0.03 pts · 57,675 reports · Conjugated Estrogen 3.08%death share
- guanfacine Δ 0.04 pts · 7,386 reports · Central Alpha-2 Agonist 3.09%death share
- omalizumab Δ 0.05 pts · 79,748 reports · Anti-IgE Monoclonal Antibody 3.00%death share
- imiquimod Δ 0.07 pts · 2,179 reports · Immune Response Modifier (Topical) 2.98%death share
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Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
What the FDA Data Shows for biotin
The FDA label for biotin (sold under brand names such as Vitamin B7) classifies it as an over-the-counter product in the Vitamin B7 Supplement class. This medicine is for people on kidney dialysis. Labeling covers dosing, contraindications, and monitoring requirements derived from clinical trials.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 29,879 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: January 27, 2026
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages