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Tramadol Hydrochloride Extended-Release: Uses, Side Effects and Dosage

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Prescription (Rx) Controlled substance Schedule IV Boxed warning
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100 mg, 200 mg, 300 mg
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Tramadol Hydrochloride Extended-Release

CONZIP is:

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine when other pain medicines do not treat your pain well enough or you cannot tolerate them.
  • A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
  • Not to be taken on an "as needed" basis.

Important information about CONZIP:

  • Get emergency help right away or call 911 right away if you take too much CONZIP (overdose). When you first start taking CONZIP, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose.
  • Taking CONZIP with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
  • Never give anyone else your CONZIP. They could die from taking it. Selling or giving away CONZIP is against the law.
  • Store CONZIP securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Important Information Guiding Use in Pediatric Patients:

  • Do not give CONZIP to a child younger than 12 years of age.
  • Do not give CONZIP to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
  • Avoid giving CONZIP to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems.

Do not take CONZIP if you have:

  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or have narrowing of the stomach or intestines.

Before taking CONZIP, tell your healthcare provider if you have a history of:

  • head injury, seizures
  • problems urinating
  • liver, kidney, thyroid problems
  • pancreas or gallbladder problems
  • abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.

Tell your healthcare provider if you are:

  • noticing your pain getting worse. If your pain gets worse after you take CONZIP, do not take more of CONZIP without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking CONZIP.
  • pregnant or planning to become pregnant. Use of CONZIP for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. Not recommended during treatment with CONZIP; it may harm your baby.
  • living in a household where there are small children or someone who has abused street or prescription drugs.
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking CONZIP with certain other medicines can cause serious side effects that could lead to death.

When taking CONZIP:

  • Do not change your dose. Take CONZIP exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • Take your prescribed dose once a day at the same time every day. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
  • Swallow CONZIP whole. Do not split, break, chew, crush, dissolve, snort, or inject CONZIP because this may cause you to overdose and die.
  • Call your healthcare provider if the dose you are taking does not control your pain.
  • Do not stop taking CONZIP without talking to your healthcare provider.
  • Dispose of expired, unwanted, or unused CONZIP by taking your drug to an authorized DEA-registered collector or drug take-back program. If one is not available, you can dispose of CONZIP by mixing the product with dirt, cat litter, or coffee grounds; placing the mixture in a sealed plastic bag and throwing the bag in your trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

While taking CONZIP DO NOT:

  • Drive or operate heavy machinery, until you know how CONZIP affects you. CONZIP can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with CONZIP may cause you to overdose and die.

The possible side effects of CONZIP:

  • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, seizure. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help or call 911 right away if you have:

  • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of CONZIP. Call your healthcare provider for medical advice about side effects. You may report side effects to Vertical Pharmaceuticals, LLC at 1-800-541-4802 or FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov

Distributed by: Vertical Pharmaceuticals, LLC, Alpharetta, GA 30005, USA, call 1-800-541-4802.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 022370 · View the label on DailyMed

Revision date stated in the text: December 2025

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Tramadol Hydrochloride Extended-Release

Rx or OTC
Prescription (Rx), Controlled substance?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • This drug is a controlled substance under the federal Controlled Substances Act.
  • Rx
Controlled substance Schedule IVSchedule IV: low potential for abuse relative to Schedule III.
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Opioid Agonist
Active ingredient Tramadol hydrochloride
Dosage form Capsule, extended release
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) CIPHER PHARMS INC
FDA approval NDA 022370New Drug Application (NDA) Approved May 7, 2010
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
100 mg – 30 in 1 bottle, plastic NDC 68025-071-30
200 mg – 30 in 1 bottle, plastic NDC 68025-072-30
300 mg – 30 in 1 bottle, plastic NDC 68025-073-30

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.