Bitolterol: uses, dosing, side effects & brands
Bitolterol is a medicine sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Available as
- Solution · Spray/Inhaler, metered
- Sold as
- Tornalate
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
Every bitolterol product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Tornalate.
Bitolterol and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for bitolterol: levels in milk, effects in breastfed infants, and the drugs it would consider insteadBitolterol is no longer marketed in the US. Although no published data exist on the use of bitolterol by mouth or inhaler during lactation, data from the closely related drug, terbutaline, indicate that very little is expected to be excreted into breastmilk. The authors of several reviews and an expert panel agree that use of inhaled bronchodilators is acceptable during breastfeeding because of the low bioavailability and maternal serum levels after use.
National Institute of Child Health and Human Development, record revised May 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about bitolterol
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 2 reports naming bitolterol, and the FDA flagged 50% 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:
- drug hypersensitivity1 reports
- hemiparesis1 reports
- muscular weakness1 reports
- psychotic disorder1 reports
Read these as a signal, not a rate. A report does not mean bitolterol 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 25, 2026.
Related calculators
Frequently asked questions
Can you take bitolterol 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 bitolterol against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does bitolterol come in?
Across the brands we track, bitolterol is currently marketed as solution and spray/inhaler, metered, 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 bitolterol?
We do not currently list a generic-labelled bitolterol 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). Bitolterol: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/bitolterol
- MLA
- “Bitolterol: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/bitolterol.
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 bitolterol on DailyMed (NIH) ↗.