Tolbutamide: uses, dosing, side effects & brands
Tolbutamide is a medicine sold in the U.S. under 2 brand and generic names. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Available as
- Tablet · Injectable
- Sold as
- 2 products — Orinase and Orinase Diagnostic
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
Every tolbutamide product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Tablet | No data | — | View → | |
| 2 | Not yet rated | Prescription | Injectable | No data | — | View → |
Tolbutamide and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for tolbutamide: levels in milk, effects in breastfed infants, and the drugs it would consider insteadTolbutamide is no longer marketed in the United States. It is excreted into breastmilk in small amounts that should cause no harm to the breastfed infant. Monitor breastfed infants for signs of hypoglycemia such as jitteriness, excessive sleepiness, poor feeding, seizures cyanosis, apnea, or hypothermia. If there is concern, monitoring of the breastfed infant's blood glucose is advisable during maternal therapy with hypoglycemic agents.
National Institute of Child Health and Human Development, record revised May 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about tolbutamide
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 459 reports naming tolbutamide, and the FDA flagged 95% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- fatigue34 reports
- dizziness28 reports
- dyspnoea27 reports
- malaise27 reports
- arthralgia26 reports
- fall24 reports
- nausea24 reports
- pneumonia24 reports
Read these as a signal, not a rate. A report does not mean tolbutamide caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
Related calculators
Frequently asked questions
Can you take tolbutamide with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run tolbutamide against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is tolbutamide sold under?
We track 2 tolbutamide-containing products in the U.S.: Orinase and Orinase Diagnostic. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does tolbutamide come in?
Across the brands we track, tolbutamide is currently marketed as tablet and injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic tolbutamide?
We do not currently list a generic-labelled tolbutamide product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Tolbutamide: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/tolbutamide
- MLA
- “Tolbutamide: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/tolbutamide.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for tolbutamide on DailyMed (NIH) ↗.