RxDecoder My Rx
‹ All drugs

methocarbamol

Sold as Tanlor, Atmeksi, Robaxin. Class: Carbamic acid esters. First FDA approval 07/16/1957: 69 years on the US market.

This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.

C

Score breakdown (67/100)

Safety ×35%
B
Evidence ×25%
F
Regulatory ×15%
B
Money & lawsuits ×15%
A
Options ×10%
A

Safety: 80

Evidence: 6

Regulatory history: 82

Money & lawsuits: 100

Options: 100

Independent reviews and post-approval warnings

Prescrire: drug to avoid

Methocarbamol has many adverse effects, in particular gastrointestinal and cutaneous disorders (including angioedema) (Rev Prescrire n° 282, 338, 468, 480).

Prescrire is a French independent review funded only by subscribers, with no industry money. Its annual "drugs to avoid" list (2026 edition, section: Haematology) names drugs it judges more harmful than useful in every authorised indication. Its view is one expert opinion, reached without a conflict of interest.

What the FDA label says

Approved uses

INDICATIONS AND USAGE Methocarbamol tablets, USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.

Contraindications

CONTRAINDICATIONS Methocarbamol tablets, USP are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

Warnings and precautions

WARNINGS Since methocarbamol may possess a general CNS depressant effect, patients receiving Methocarbamol tablets, USP should be cautioned about combined effects with alcohol and other CNS depressants. Safe use of Methocarbamol tablets, USP has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, Methocarbamol tablets, USP should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see Precautions, Pregnancy ). Use In Activities Requiring Mental Alertness Methocarbamol may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that methocarbamol therapy does not adversely affect their ability to engage in such activities.

Adverse reactions (label)

ADVERSE REACTIONS Adverse reactions reported coincident with the administration of methocarbamol include: Body as a whole: Anaphylactic reaction, angioneurotic edema, fever, headache Cardiovascular system: Bradycardia, flushing, hypotension, syncope, thrombophlebitis Digestive system: Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting Hemic and lymphatic system: Leukopenia Immune system: Hypersensitivity reactions Nervous system: Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo Skin and special senses: Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria

Source: FDA SPL label for Methocarbamol (Aphena Pharma Solutions - Tennessee, LLC), effective 20211110. Full label on DailyMed.

Side-effect reports sent to the FDA

These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.

19,785reports that mention this drug
19,745of those blame this drug, not another one the person was taking
61%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)
7.2%of reports include a death, from any cause (average for all drugs: 9.1%)

Problems reported most often

Fatigue · 1,474Nausea · 1,426Pain · 1,423Drug Ineffective · 1,310Headache · 1,116Diarrhoea · 1,027Off Label Use · 947Fall · 935Arthralgia · 863Dyspnoea · 845Dizziness · 796Chronic Kidney Disease · 783Back Pain · 728Vomiting · 706Anxiety · 681

Reports per year

20192020202120222023202420252026
1,8741,9911,5141,4841,4961,7022,2421,231

1,613 reports blaming this drug for every million Medicare prescriptions filled, which is 0.6× the typical drug on this site. (5,146 reports in 2024–2026, against 3,191,039 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)

Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.

Recalls and regulatory record

2recall actions on file
3 / 50brand / generic applications
0label changes since 2021
NoREMS program
DateClassFirmReason
03/2025Class IISomerset Therapeutics Private LimitedLack of Assurance of Sterility: Media fill with bacterial contamination
02/2024Class IEugia US LLCPresence of Particulate Matter

Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.

Evidence base

11randomized trials (PubMed)
0systematic reviews
45registered trials
41%of completed trials posted results
18%terminated or withdrawn
38%industry-funded

Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.

Money and lawsuits

In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.

No pending federal MDL names this drug or its brands.

Not named in any federal pharmaceutical settlement of $100M or more on record.

Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.

Who takes it and what it costs

1,343,692Medicare Part D patients (2024)
3,191,039prescriptions filled
$11average cost per fill
$36Mtotal Medicare spend
ProductFills$/fill
Methocarbamol3,190,991$11
Tanlor48$1,744

Same-class alternatives

carisoprodolfebarbamatestyramate

Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.

Questions to ask your prescriber

  1. An independent reviewer (Prescrire) lists this as a drug to avoid because the harms outweigh the benefits versus alternatives. What is your view on that?
  2. The most-reported problems in FDA's adverse event data are fatigue, nausea, pain. How would we recognize and handle those?
  3. Why this one over carisoprodol, febarbamate, styramate? What would make you pick one of those instead?
  4. What result are we expecting, by when, and what is the plan if it does not happen?
  5. If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)