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.
How to Take It
Take one tablet each day. You can take it with or without food. Follow your doctor's directions. Swallow the tablet whole with a glass of water.
This is a plain-language summary of biotin's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Talk to your doctor if you are pregnant or breastfeeding before taking this medicine. They can advise you on whether it is safe for you and your baby.
This is a plain-language summary of biotin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of biotin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature away from moisture and heat.
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
- Tiredness
Tiredness
3,046 reports
- Feeling sick to your stomach
Feeling sick to your stomach
2,251 reports
- Hair loss
Hair loss
2,194 reports
- Head pain
Head pain
2,142 reports
- Loose stools
Loose stools
1,894 reports
- Aches
Aches
1,703 reports
- Feeling lightheaded
Feeling lightheaded
1,583 reports
- Joint pain
Joint pain
1,426 reports
- Difficulty breathing
Difficulty breathing
1,404 reports
- Itching
Itching
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) 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?
Is biotin safe during pregnancy?
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.
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calcitriol
Rocaltrol
Calcitriol is a form of vitamin D that helps your body absorb and use calcium.
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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.
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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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: January 27, 2026
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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