Tramadol
Tramadol Hydrochloride · Say it: tra-MA-dol
Tramadol is a strong prescription opioid pain medicine for adults with pain severe enough to need an opioid, when other treatments are not enough. It carries serious risks, including addiction, overdose, and death.
⬛ Boxed warning (the FDA's strongest warning)
The label has a boxed warning, its strongest type of warning, with these points. Addiction, abuse, and misuse: tramadol can lead to opioid addiction, abuse, and misuse, which can cause overdose and death, so the prescriber should assess each patient's risk before prescribing and check regularly. Life-threatening breathing problems: serious or fatal slowed breathing (respiratory depression) can occur, especially when starting or after a dose increase. Accidental ingestion: even one dose can cause a fatal overdose, especially in children. Risks with benzodiazepines or other CNS depressants, including alcohol: this combination may cause severe sleepiness, slowed breathing, coma, and death, so such combined prescribing should be reserved for patients who have no adequate alternatives. Neonatal opioid withdrawal syndrome: use during pregnancy for an extended time can cause withdrawal in the newborn, which may be life-threatening if not recognized and treated. REMS: healthcare providers are encouraged to complete an education program and counsel patients on risks and safe use. Ultra-rapid metabolism in children: life-threatening breathing problems and deaths have occurred in children who received tramadol, some after tonsil or adenoid removal.
Used for
The label says tramadol is used in adults to manage pain severe enough to require an opioid analgesic, when alternative treatments are inadequate. The label notes that other pain treatments, such as non-opioid pain medicines, may be tried first, and that opioids should be reserved for patients for whom other options are ineffective, not tolerated, or otherwise inadequate.
Comes as
Tablets: 50 mg, pale yellow, capsule-shaped, film-coated tablets marked "355" and "U".
Common side effects
Dizziness or lightheadedness, Nausea, Constipation
| Generic name | Tramadol Hydrochloride |
|---|---|
| Brand names | — |
| Type of medicine | an opioid pain medicine, also called an opioid analgesic |
| How it is sold | Prescription opioid pain medicine (Schedule IV controlled substance) |
| Comes as | Tablets: 50 mg, pale yellow, capsule-shaped, film-coated tablets marked "355" and "U". |
| Route | oral |
| Boxed warning | Yes, see below |
| Label date | 2026-04-10 |
💊 What is Tramadol used for?
- The label says tramadol is used in adults to manage pain severe enough to require an opioid analgesic, when alternative treatments are inadequate. The label notes that other pain treatments, such as non-opioid pain medicines, may be tried first, and that opioids should be reserved for patients for whom other options are ineffective, not tolerated, or otherwise inadequate.
How it works
The label describes tramadol as an opioid agonist, which means it acts on opioid receptors in the body to reduce pain. The label also explains that the body changes tramadol into other compounds that are more potent opioid agonists.
How it is usually taken
- The label says to take tramadol exactly as your prescriber directs. People are usually told to use the lowest effective dose for the shortest time needed. Do not change your dose on your own. The label says that for short-term (acute) pain, you may only need it for a few days. Follow the instructions from your prescriber or pharmacist about how often to take it and the daily maximum. Do not stop taking it suddenly after regular use without talking to your prescriber.
Comes as
- Tablets: 50 mg, pale yellow, capsule-shaped, film-coated tablets marked "355" and "U".
⚠️ Tramadol side effects
Common side effects
- Dizziness or lightheadedness
- Nausea
- Constipation
- Headache
- Sleepiness (somnolence)
- Vomiting
- Itching (pruritus)
Get medical help right away if
- Get emergency help or call 911 right away if you take too much tramadol (overdose). Serious or life-threatening breathing problems can occur, especially when you first start the medicine, when the dose changes, or after an overdose.
- Get medical help right away if you have slowed or trouble breathing, extreme sleepiness, confusion, or trouble staying awake.
- Get medical help right away if you have signs of serotonin syndrome, which the label says can be life-threatening.
- Get medical help right away if you have a seizure. The label says seizures can occur at the recommended dose.
- Get medical help right away if you have thoughts of suicide. The label warns about suicide risk.
- Get medical help right away if you feel faint or have severe low blood pressure. The label warns about severe hypotension.
- Get medical help right away if you have signs of adrenal insufficiency, such as those a prescriber would check for. The label says it may be diagnosed and treated.
- Get medical help right away if you notice your pain getting worse, feeling more sensitive to pain, or new pain after taking tramadol. The label describes opioid-induced increased pain sensitivity, and your prescriber should be told.
- Get medical help right away if you have a serious allergic reaction. The label lists hypersensitivity reactions as a serious risk.
- For a newborn: the label says extended use during pregnancy can cause withdrawal in the baby, and breastfeeding infants may show increased sleepiness, breathing difficulties, or limpness. Seek immediate medical care if these signs appear.
🛑 Who should not take Tramadol, and who should be careful
The label says not to take it if
- You have severe asthma, trouble breathing, or other lung problems. The label says it is contraindicated in significant respiratory depression and in acute or severe asthma without monitoring or resuscitation equipment.
- You have a bowel blockage or narrowing of the stomach or intestines (the label lists known or suspected gastrointestinal obstruction, including paralytic ileus).
- You are allergic to tramadol, any other ingredient in the product, or opioids.
- You have taken a monoamine oxidase inhibitor (MAOI), a medicine used for depression, within the last 14 days.
- The label says tramadol is contraindicated in children younger than 12 years of age.
- The label says it is contraindicated in children younger than 18 years of age after tonsil or adenoid removal.
Tell your doctor before taking it if
- Tell your prescriber if you have had a head injury or seizures.
- Tell your prescriber if you have liver, kidney, or thyroid problems.
- Tell your prescriber if you have trouble urinating.
- Tell your prescriber if you have pancreas or gallbladder problems.
- Tell your prescriber if you have a history of abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.
- Tell your prescriber if you are pregnant or planning to become pregnant, or if you are breastfeeding.
- Tell your prescriber if you live in a home with small children or someone who has abused street or prescription drugs.
- Tell your prescriber about all prescription and over-the-counter medicines, vitamins, and herbal supplements you take.
- The label says not to drive or operate heavy machinery until you know how tramadol affects you, because it can cause sleepiness, dizziness, or lightheadedness.
- The label says to store tramadol securely, out of sight and reach of children and others in the home, including visitors.
🔀 Tramadol with other medicines, food and alcohol
The label says to discuss these with your doctor or pharmacist
- Monoamine oxidase inhibitors (MAOIs): do not use with MAOIs or within 14 days of stopping them.
- Benzodiazepines and other CNS depressants, including alcohol: can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
- Other opioid medicines: combined use can cause severe drowsiness, breathing problems, coma, and death.
- Gabapentinoids such as gabapentin or pregabalin: combined use can cause severe drowsiness and breathing problems.
- CYP2D6 inhibitors, such as quinidine, fluoxetine, paroxetine, and bupropion: these can increase tramadol levels and raise the risk of seizures and serotonin syndrome, and can change how the medicine works when started or stopped.
- CYP3A4 inhibitors: these can increase tramadol levels and raise the risk of serious side effects, including seizures and serotonin syndrome.
- Serotonergic drugs: the label says they can increase the risk of serotonin syndrome.
- Street drugs: combined use with CNS depressants can cause severe side effects, according to the label.
- Tell your prescriber or pharmacist about all medicines you take, including over-the-counter medicines, vitamins, and herbal supplements.
Alcohol and food
The label says not to drink alcohol or use prescription or over-the-counter medicines that contain alcohol while taking tramadol, because alcohol can cause severe sleepiness, breathing problems, coma, and death. The label does not give specific food instructions.
🤰 Tramadol in pregnancy and breastfeeding
Pregnancy
The label says tramadol may cause fetal harm. Animal studies showed effects on fetal weight and development at doses related to the human maximum dose. Use of opioids for an extended period during pregnancy can cause neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. Talk to your prescriber if you are pregnant or planning a pregnancy.
Breastfeeding
The label says breastfeeding is not recommended. Tramadol passes into breast milk and may harm the baby. Watch infants closely for more sleepiness than usual, breathing difficulties, or limpness, and seek immediate medical care if these occur.
🗓️ Storage, missed doses and taking too much
Storage
Store at 20 to 25 degrees C (68 to 77 degrees F). Store securely, out of sight and reach of children and others in the home. The label says to dispose of unused or expired tramadol by taking it to a DEA-registered collector or drug take-back program. If none is available, the label describes mixing it with dirt, cat litter, or coffee grounds, sealing it in a plastic bag, and throwing it in the trash. More information is at www.fda.gov/drugdisposal.
If a dose is missed
The label says that if you miss a dose, take your next dose at your usual time. Do not take more than your prescribed dose to make up for a missed one. Ask your prescriber or pharmacist if you have questions.
If too much is taken
The label says acute overdose can cause slowed breathing, sleepiness that progresses to stupor or coma, limp muscles, cold and clammy skin, small pupils, seizures, and death. Get emergency help or call 911 right away if you think someone has taken too much. The label says to ask your prescriber about medicines such as naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose.
🗒️ Questions to ask about Tramadol
🎯 Check what you understood
1. According to the label, what is one reason tramadol can be dangerous when combined with alcohol?
2. What does the label say about taking more tramadol than prescribed if pain gets worse?
3. What does the label say about tramadol and children younger than 12?
❓ Tramadol: frequently asked questions
What is tramadol used for?
The label says tramadol is used in adults to manage pain severe enough to need an opioid, when other treatments are not adequate. It is a prescription opioid pain medicine.
Can I drink alcohol while taking tramadol?
The label says not to drink alcohol or use products containing alcohol during treatment. Alcohol combined with tramadol can cause severe sleepiness, breathing problems, coma, and death.
What should I do if I miss a dose?
The label says to take your next dose at your usual time. Ask your prescriber or pharmacist if you have questions about missed doses.
How should I store tramadol?
The label says to store it at 20 to 25 degrees C (68 to 77 degrees F), securely, and out of sight and reach of children and others in the home.
Can I take tramadol while pregnant or breastfeeding?
The label says tramadol may cause fetal harm and that extended use during pregnancy can cause newborn withdrawal. It also says breastfeeding is not recommended because tramadol passes into breast milk and may harm the baby.
🧪 Tests and reports linked to Tramadol
The label text mentions these. If you have one of these reports, get every line of it explained.
- Kidney function tests
a test or report linked to this medicine
- Metabolic panel (BMP, CMP)
a test or report linked to this medicine
- Thyroid tests
a test or report linked to this medicine
- Pregnancy hCG test
a test or report linked to this medicine
📖 Medical words used on this page
- Acute vs chronic
Acute means something started recently or suddenly. Chronic means it has lasted a long time or keeps coming back.
- Adrenal insufficiency
Adrenal insufficiency means the adrenal glands do not make enough cortisol. A sudden severe form, adrenal crisis, is an emergency.
- Allergic reaction
An allergic reaction is when the immune system overreacts to something harmless, such as a medicine or food, causing symptoms from a rash to swelling.
- Benzodiazepine
A benzodiazepine is a type of calming medicine used for anxiety, sleep problems, seizures or muscle spasm. It can cause drowsiness and dependence.
- Boxed warning
A boxed warning is the strongest safety warning on a US medicine label, printed in a box, about a serious or life-threatening risk.
- Bronchospastic Disease
Bronchospastic disease means a lung condition, such as asthma, in which the airways tend to tighten suddenly (bronchospasm).
- CNS depressant
A CNS depressant is any medicine or substance that slows down brain and nerve activity, causing drowsiness, relaxation or slower breathing.
- Contraindication
A contraindication is a reason not to use a particular medicine, test or procedure for a person because it could cause harm.
- Controlled substance
A controlled substance is a medicine or drug whose making, prescribing and supply are tightly regulated by law because it can be misused or cause dependence.
- CYP3A
CYP3A is a family of enzymes, mainly in the liver and gut, that break down a large share of commonly used medicines.
- CYP3A4
CYP3A4 is a liver and gut enzyme that breaks down many medicines. Drugs or foods that block or boost it can change medicine levels.
- Discontinuation syndrome
Discontinuation syndrome is a set of symptoms that can appear when a medicine, often an antidepressant, is stopped suddenly or reduced too fast.
- Film-coated
Film-coated means a tablet has a thin outer layer that makes it easier to swallow, masks taste, or protects the medicine inside.
- Gastrointestinal
Gastrointestinal (GI) means relating to the digestive tract: the mouth, esophagus, stomach and intestines.
📖 Medical words on this page
⚖️ Compare
Have the leaflet or prescription in front of you?
Explain my leafletDecode my prescription🔗 Trusted sources about Tramadol
- Full official label on DailyMed ↗
US National Library of Medicine: the complete FDA label this page is based on
- Tramadol on MedlinePlus ↗
US National Library of Medicine's patient drug information
- Tramadol on the NHS website ↗
UK National Health Service medicine guide
Report a side effect or check safety alerts
- Report a side effect in the US (FDA MedWatch) ↗
- Report a side effect in the UK (Yellow Card) ↗
- FDA recalls and safety alerts ↗
Explain your own documents
Source: official FDA drug label (label updated 2026-04-10). Read the full label on DailyMed
MedicDecode explains the official label in plain words. It is not medical advice and does not replace your doctor or pharmacist. Never start, stop or change a medicine because of what you read here.