Tramadol

generic for Ultram

Tramadol Warnings

Tramadol has a risk for abuse and addiction, which can lead to overdose and death. Tramadol may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of tramadol that works, and take it for the shortest possible time. See also How to Use section for more information about addiction.

The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you take the wrong dose/strength. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Also, other medications can affect the removal of tramadol from your body, which may affect how tramadol works. Be sure you know how to take tramadol and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.

Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this drug, get medical help right away.

Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn't stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight.

Children younger than 12 years should not use products that contain tramadol. Children between 12 and 18 years old should not use tramadol after certain surgeries (including tonsil/adenoid removal). Also, tramadol use is not recommended for children between 12 and 18 years old who are obese or have breathing problems. Some children are more sensitive to tramadol and have had very serious (rarely fatal) breathing problems such as slow/shallow breathing (see also Side Effects section). Talk with your doctor or pharmacist about the risks and benefits of this medication.
  • CAUTION: Opioid. Risk of overdose and addiction.
  • Warning: Breastfeeding is not recommended while using this drug. Consult your doctor or pharmacist.
  • May cause drowsiness and dizziness. Alcohol and marijuana may intensify this effect. Use care when operating a vehicle, vessel (e.g., boat), or machinery.
  • If you are pregnant or of childbearing age, discuss the risks/benefits of this medication with your doctor and pharmacist.
  • Using more of this medication than recommended may cause serious breathing problems.
  • Do not drink alcoholic beverages when using this medication.
  • CAUTION: Ask your doctor before using this drug with other opioids, sleep or anxiety drugs, or other drugs that can cause serious breathing problems/drowsiness.
  • Read the boxed warning information for this medication.

Lactation Warnings

  • LOW AMOUNTS EXCRETED; MONITOR FOR RESPIRATORY DEPRESSION

Pregnancy Warnings

  • Neonatal opioid withdrawal syndrome may occur. Monitor neonates for opioid withdrawal syndrome and manage accordingly. Transplacental transfer has been reported. Animal data suggest developmental toxicity at doses less than10 times the maximum recommended human dose.