Tramadol (tramadol hydrochloride)

Tramadol is an opioid pain medicine. The label we reviewed is for tramadol hydrochloride tablets taken by mouth.

The label says it is for adults with pain severe enough to need an opioid analgesic, when other treatments are not enough or are not tolerated.

Because of the risk of addiction, abuse and misuse, even at recommended doses, the label says to reserve it for those cases. It also says not to use it for an extended period unless the pain still needs an opioid.

• Severe pain in adults when alternatives have not worked or are not tolerated
• Not for long-term use unless pain remains severe and alternatives continue to fail

The label describes tramadol as an opioid agonist and an inhibitor of norepinephrine and serotonin re-uptake.

Pain relief is believed to come from binding to mu-opioid receptors and weak inhibition of norepinephrine and serotonin re-uptake. The label says the mode of action is not completely understood.

An active breakdown product called M1 binds more strongly to opioid receptors. Pain relief begins about an hour after a dose and peaks in about 2 to 3 hours.

This section covers the tramadol hydrochloride tablet label for adults (50 mg tablets, oral route). Indian capsules, prolonged-release tablets and injections differ, and the prescriber decides.

The label says it should be prescribed only by clinicians who know opioids and how to reduce their risks, at the lowest effective dose for the shortest time.

For a gradual start, the label describes beginning at 25 mg a day and raising by 25 mg every 3 days to 100 mg a day, then by 50 mg every 3 days to 200 mg a day. After this, it gives 50 to 100 mg as needed every 4 to 6 hours, with a limit of 400 mg a day.

In severe kidney impairment, the label lengthens the interval to 12 hours with a limit of 200 mg a day. In severe liver impairment, it gives 50 mg every 12 hours.

The label says not to use tramadol with other tramadol-containing products and not to stop it suddenly if physically dependent, because of withdrawal, uncontrolled pain and suicide.

• Lowest effective dose for the shortest time
• Limit of 400 mg a day on the US label
• Do not use with other tramadol products
• Do not stop suddenly if dependent; ask your doctor

The label has a boxed warning covering addiction, abuse and misuse, life-threatening breathing depression, accidental ingestion, risks with benzodiazepines and other sedatives, newborn opioid withdrawal, ultra-rapid metabolism in children, and drug interactions affecting the CYP450 system.

The label says tramadol must not be used in children under 12, after tonsil or adenoid surgery in those under 18, in significant breathing depression, in acute or severe asthma without monitoring, in bowel blockage, with an opioid allergy, or with MAO inhibitors now or in the past 14 days.

Seizures can occur even at recommended doses, with higher risk in epilepsy or a history of seizures. The label says not to prescribe it to suicidal or addiction-prone patients.

Pregnancy: long use may cause newborn opioid withdrawal syndrome, and it is not recommended around labor. Breastfeeding: not recommended.

Older adults: constipation and breathing depression risks are higher, so the label says to start at the low end and increase slowly.

• Not for children under 12
• Not with MAO inhibitors or within 14 days
• Seizure risk, including at normal doses
• Do not combine with alcohol, sedatives or benzodiazepines
• Pregnancy and breastfeeding: not recommended

• MAO inhibitors: contraindicated
• Benzodiazepines, other opioids, alcohol: breathing depression
• CYP2D6 and CYP3A4 inhibitors: higher tramadol levels
• Serotonergic medicines: serotonin syndrome
• The label says tramadol must not be used with MAO inhibitors, or within 14 days of stopping them.
• Benzodiazepines, other sedatives, other opioids and alcohol add to breathing depression and sedation.
• CYP2D6 inhibitors such as quinidine, fluoxetine, paroxetine and bupropion can raise tramadol levels and lower its active M1 product, with higher risk of seizures and serotonin syndrome.
• CYP3A4 inhibitors, including macrolide antibiotics and azole antifungals, can also raise tramadol levels.
• Serotonergic medicines add to the risk of serotonin syndrome.
• Tell your pharmacist about every medicine, including over-the-counter ones.

No match in this label text. Ask your pharmacist about any medicine you take.

The label says overdose can cause slowed breathing, sleepiness progressing to stupor or coma, cold and clammy skin, small pupils, a slow heartbeat, low blood pressure, seizures and death.

It says the risk of fatal overdose is higher when tramadol is used with alcohol or other CNS depressants. Naloxone is an antidote for breathing depression, but it may not reverse all effects and can raise seizure risk. Treat any overdose or accidental ingestion as an emergency.

The US label says to store tablets at 20 to 25 degrees C in a tight container.

It says to store them securely and dispose of them properly. Keep them out of reach of children and never share them.

Tramadol hydrochloride is in Schedule H (serial 507), and tramadol is also in Schedule H1 (serial 45), so it is sold only on a prescription.

The National List of Essential Medicines 2022 includes tramadol as 50 mg and 100 mg capsules and a 50 mg per mL injection (pages 62 and 85). We did not find plain tablets in the rows we checked.

NPPA has ceiling prices for tramadol tablets, capsules and injection. The March 2026 list and the 2020 list are shown below.

Banned combinations: the list we checked has 3 mentions of tramadol. Use the checker for your exact combination.

NPPA ceiling prices set the most a seller can charge per unit before local taxes. Check the pack and the seller.

Jan Aushadhi lists tramadol injections, 50 mg tablets, prolonged-release tablets and a tramadol and diclofenac combination. Combination products also contain other medicines, so read the label. We have not shown a brand price here.

• Tramadol Hydrochloride Injection 100 mg per 2 ml (pack 2 ml)
• Tramadol HCl Injection 50mg 1 ml (pack 1 ml)
• Tramadol Tablets 50mg (pack 10's)
• Tramadol Prolonged Release Tablets IP 100 mg (pack 10's)
• Tramadol Hydrochloride (IR) 50mg and Diclofenac Sodium (SR) 75mg Tablets (pack 10's)