Skip to content
ppharmaranks
Menu

Baclofen: uses, dosing, side effects & brands

Baclofen is a gamma-aminobutyric acid-ergic agonist sold in the U.S. under 7 brand and generic names, for neurogenic urinary bladder, cerebral palsy and hiccup. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Drug class
Gamma-Aminobutyric Acid-Ergic Agonist
Treats (across its forms)
Neurogenic Urinary Bladder, Cerebral Palsy and Hiccup
Available as
Tablet, orally disintegrating · Injectable · Tablet · Powder · Solution · Suspension
Sold as
7 products — Kemstro, Lioresal and Lyvispah, and others
Prescription?
Prescription only
Generic available?
Yes
Half-life
about 5.7 hours
What the pharmacy pays
about $2 for a 30-count supply — not your price
Boxed warning
Boxed warning

How Lyvispah is dosed

From the FDA label for Lyvispah (application NDA215422). Other baclofen products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Initiate LYVISPAH with a low dosage, preferably in divided doses, administered orally. Increase gradually based on clinical response and tolerability. ( 2.1 ) The maximum dosage is 80 mg daily (20 mg four times a day). ( 2.1 ) LYVISPAH can be taken with or without water. ( 2.2 ) LYVISPAH oral granules can be mixed with soft food for administration within 2 hours. ( 2.2 ) LYVISPAH oral granules can be administered via enteral feeding tubes. ( 2.2 ) When discontinuing, reduce the dose slowly. ( 2.2 ) 2.1 Recommended Dosage Initiate LYVISPAH with a low dosage, preferably in divided doses, administered orally. The following gradually increasing dosage regimen is suggested, but should be adjusted based on clinical response and tolerability: 5 mg three times a day for three days 10 mg three times a day for three days 15 mg three times a day for three days 20 mg three times a day for three days Additional increases may be necessary up to the maximum recommended dosage of 80 mg daily (20 mg four times a day). Multiple packets or multiple strengths can be used to achieve the prescribed dosage. 2.2 Administration Instructions The entire contents of the packet should be emptied into the mouth. The granules will dissolve in the mouth or can be swallowed. LYVISPAH can be taken with liquids or soft foods if needed . Administration with Liquids or Soft Foods LYVISPAH can be administered…

Everything below is the FDA label for Lyvispah (powder). Baclofen is also sold as tablet, orally disintegrating, injectable, tablet, solution and suspension, and those are different medicines to take — follow the label for the one you were prescribed.

Lyvispah side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Adverse Reactions from Abrupt Withdrawal of LYVISPAH [see Warnings and Precautions (5.1)] Neonatal Withdrawal Symptoms [see Warnings and Precautions (5.2)] Drowsiness and Sedation [see Warnings and Precautions (5.3)] Poor Tolerability in Stroke Patients [see Warnings and Precautions (5.4)] Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States [see Warnings and Precautions (5.5)] Exacerbation of Autonomic Dysreflexia [see Warnings and Precautions (5.6)] Exacerbation of Epilepsy [see Warnings and Precautions (5.7)] Posture and Balance Effects [see Warnings and Precautions (5.8)] Ovarian Cysts [see Warnings and Precautions (5.9)] The most common adverse reactions (up to 15% or more) in patients were drowsiness, dizziness, and weakness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reaction is transient drowsiness. In one controlled study of 175 patients,…

Who shouldn’t take Lyvispah

LYVISPAH is contraindicated in patients with hypersensitivity to baclofen. Hypersensitivity to baclofen ( 4 )

Lyvispah drug interactions

7.1 CNS Depressants and Alcohol LYVISPAH can cause CNS depression, including drowsiness and sedation, which may be an additive when used concomitantly with other CNS depressants or alcohol [see Warnings and Precautions (5.3) ].

Every baclofen product we track (7)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Baclofen products
#DrugRatingPharmacy pays
170/100$2View →
270/100$2View →
370/100$2View →
4Not yet rated$2View →
5Not yet rated$2View →
6Not yet rated$2View →
7Not yet rated$2View →

What baclofen pills look like

Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.

Baclofen pill imprints
ImprintStrengthColourShape
KP02;1010 mgwhiteround
02410 mgwhiteround
I11410 mgwhiteround

Baclofen recalls

From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.

How long baclofen keeps

The date on a sealed pack is not the only one: some baclofen labels start a second clock once the product is opened or mixed, as short as 2 months.

Does baclofen expire? The in-use limits and storage rules from its labels

Baclofen and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

Limited information indicates that orally administered baclofen appears in low levels in milk and would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. Monitor newborn infants for signs of sedation. Low intrathecal doses and topical application produce even lower milk levels and are unlikely to affect the nursing infant.

Full LactMed record for baclofen: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised October 15, 2024. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about baclofen

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 90,230 reports naming baclofen, and the FDA flagged 67% 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:

  • fatigue6,482 reports
  • fall5,735 reports
  • nausea4,977 reports
  • headache4,653 reports
  • gait disturbance4,286 reports
  • dizziness3,783 reports
  • urinary tract infection3,687 reports
  • muscle spasms3,672 reports

Read these as a signal, not a rate. A report does not mean baclofen 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 August 25, 2026.

How long baclofen stays in your system

The elimination half-life of baclofen is about 5.7 hours. This is the apparent elimination half-life of the parent drug. Baclofen is not a prodrug and has no active metabolite that outlasts it — the label states it is excreted primarily by the kidney in unchanged form, so the half-life reflects renal clearance directly. Because of that, elimination is slower in people with reduced kidney function (renal impairment) and in older adults, in whom the drug can accumulate and the dose may need to be reduced. The label also notes large intersubject variation in absorption and/or elimination, so individual half-life can differ. Half-life is not the same as a drug-test detection window: baclofen is essentially cleared within about 72 hours of a dose, but detectability depends on the test.

Baclofen oral solution — FDA label (DailyMed), Clinical Pharmacology

Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.

Can you drink alcohol on baclofen?

The label says use caution

The label's Precautions section warns that the central nervous system effects of baclofen may be additive to those of alcohol and other CNS depressants. In other words, combining baclofen with alcohol can compound sedation and drowsiness. This is an additive-CNS-depression caution, not a disulfiram-like reaction.

Baclofen Tablets — FDA Label (DailyMed)

Stopping baclofen: withdrawal & how to come off

The label's Warnings section ("Abrupt Drug Withdrawal") states that hallucinations and seizures have occurred on abrupt withdrawal of baclofen. It directs that, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued, and the Dosage and Administration section reiterates that patients should be slowly withdrawn from the drug. This is a prescriber-managed taper; it is a labeled warning but not part of a boxed warning.

This describes what the label says about stopping — not a schedule to follow on your own. Any change to baclofenis your prescriber’s decision; stopping some medicines abruptly is dangerous.

Baclofen Tablets — FDA Label (DailyMed)

Related guides

Related calculators

Frequently asked questions

What is Lyvispah?

LYVISPAH (baclofen) oral granules is a gamma-aminobutyric acid (GABA-ergic) agonist available as 5 mg, 10 mg, or 20 mg of baclofen oral granules in a packet.

What kind of drug is baclofen?

The FDA classifies baclofen as a gamma-aminobutyric acid-ergic agonist. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

Can you drink alcohol while taking baclofen?

The label's Precautions section warns that the central nervous system effects of baclofen may be additive to those of alcohol and other CNS depressants. In other words, combining baclofen with alcohol can compound sedation and drowsiness. This is an additive-CNS-depression caution, not a disulfiram-like reaction. This is what baclofen's FDA label says; alcohol advice depends on your dose and health, so confirm with your pharmacist.

What happens if you stop taking baclofen?

The label's Warnings section ("Abrupt Drug Withdrawal") states that hallucinations and seizures have occurred on abrupt withdrawal of baclofen. It directs that, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued, and the Dosage and Administration section reiterates that patients should be slowly withdrawn from the drug. This is a prescriber-managed taper; it is a labeled warning but not part of a boxed warning. Do not stop baclofen on your own — any change is a prescriber-managed decision.

How long does baclofen stay in your system?

The elimination half-life of baclofen is about 5.7 hours — that is how long the body takes to clear half of a dose. This is the apparent elimination half-life of the parent drug. Baclofen is not a prodrug and has no active metabolite that outlasts it — the label states it is excreted primarily by the kidney in unchanged form, so the half-life reflects renal clearance directly. Because of that, elimination is slower in people with reduced kidney function (renal impairment) and in older adults, in whom the drug can accumulate and the dose may need to be reduced. The label also notes large intersubject variation in absorption and/or elimination, so individual half-life can differ. Half-life is not the same as a drug-test detection window: baclofen is essentially cleared within about 72 hours of a dose, but detectability depends on the test. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.

Can you take baclofen 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 baclofen 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 baclofen sold under?

We track 7 baclofen-containing products in the U.S.: Kemstro, Lioresal, Lyvispah, Baclofen, Gablofen, Ozobax and Ozobax Ds. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does baclofen come in?

Across the brands we track, baclofen is currently marketed as tablet, orally disintegrating, injectable, tablet, powder, solution and suspension, 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 baclofen?

Yes. Our catalog lists 1 generic baclofen product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.

Has baclofen been recalled?

The FDA's Enforcement database lists 1 recall record whose product description mentions baclofen. The most recent: Baclofen Tablets USP (Nov 26, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.

What should I avoid while taking baclofen?

Alcohol: the FDA label flags alcohol as something to be careful with — see the alcohol section above for what it actually says. This is what the FDA label and our cited sources say — it is not a complete list. Your pharmacist can check your own combination.

What side effects should I expect when starting oral baclofen?

Drowsiness is the most common, along with dizziness, weakness, fatigue, nausea and sometimes confusion. These are dose-related and usually heaviest in the first days after a start or a dose increase, which is exactly why baclofen is titrated up slowly rather than started at a full dose. Most people find the sedation settles over one to two weeks at a steady dose. Taking it with food helps the nausea. Don't drive or operate machinery until you know how it affects you, and expect a fresh wave of drowsiness after every dose increase, not just the first one.

What happens if I stop baclofen suddenly?

Abrupt discontinuation of baclofen has caused hallucinations and seizures — that warning is on the oral label. The label's fuller description of the withdrawal syndrome also includes high fever, altered mental status, exaggerated rebound spasticity and muscle rigidity, which in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death. That severe end of the spectrum is best known from intrathecal baclofen pumps, where it carries a boxed warning, but the oral label carries the same language and the same instruction: reduce the dosage slowly unless the clinical situation justifies rapid withdrawal. Don't let prescriptions lapse, and if you're hospitalized, make sure the team knows you take it.

Which baclofen side effects need urgent medical attention?

Call 911 or go to an ER for a seizure, hallucinations or new severe confusion, unresponsiveness or extreme sleepiness, or slow and shallow breathing. Call your doctor promptly for progressive confusion, slurred speech or increasing daytime sleepiness that doesn't match your dose. Kidney function is the hidden variable: baclofen is excreted primarily unchanged by the kidneys, so reduced kidney function lets it accumulate, and the label calls for caution and says a dosage reduction may be necessary. In people with chronic kidney disease or on dialysis, a standard dose can build up into confusion, deep sedation or coma. Baclofen should also be used with caution if you have epilepsy — worsening seizure control has been reported.

What makes baclofen's side effects worse, and what's the catch with muscle weakness?

Alcohol, opioids, benzodiazepines, gabapentin, pregabalin, other muscle relaxants and sedating antihistamines all stack on top of baclofen's sedation. Combining them is the usual reason a stable dose suddenly feels overwhelming. The weakness issue is subtler and worth planning for: baclofen works by reducing muscle tone, and some people rely on that stiffness to stand, transfer or walk — the label specifically flags patients who use spasticity to sustain upright posture and balance. If stiffness is doing structural work for you, loosening it can make mobility worse, not better. Track whether your walking, transfers and balance improve or decline over the first few weeks, and bring that specific observation back to the prescriber.

What is baclofen used for?

Baclofen is a muscle relaxant FDA-approved to treat spasticity — muscle tightness, stiffness, and spasms — caused by multiple sclerosis and by spinal cord injuries or diseases. It works on the spinal cord to reduce the number and severity of muscle spasms and can ease related pain. It comes as tablets and, for severe cases, as an implanted pump (intrathecal).

Is baclofen used off-label for anything?

Yes. Baclofen is prescribed off-label for alcohol use disorder to reduce cravings, for persistent hiccups, and sometimes for GERD-related symptoms or muscle spasms from other causes. These uses are not FDA-approved, and the evidence for alcohol use disorder in particular is mixed and still debated.

Can you stop baclofen suddenly?

No — stopping baclofen abruptly, especially after long-term or high-dose use, can cause serious withdrawal including hallucinations, seizures, high fever, and muscle rigidity, which can be life-threatening. The dose should always be lowered gradually under a doctor's supervision. Common everyday side effects are drowsiness, weakness, and dizziness.

Cite this page
APA
pharmaranks. (2026, July 24). Baclofen: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/baclofen
MLA
“Baclofen: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/baclofen.

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 baclofen on DailyMed (NIH) ↗ — including its boxed warning in full.