Tramadol Pregnancy and Breastfeeding Warnings

Tramadol is also known as: ConZip, GenRx Tramadol, Rybix, Rybix ODT, Ryzolt, Tramahexal SR, Tramal, Tramal SR, Tramedo, Ultram, Ultram ER, Ultram ODT, Zamadol, Zydol

Overview

Tramadol has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Tramadol while you are pregnant. Tramadol is found in breast milk. Do not breast-feed while taking Tramadol.

Tramadol Pregnancy Warnings

Tramadol has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryotoxicity and fetotoxicity. There are no controlled data in human pregnancy. Tramadol should only be given during pregnancy when benefit outweighs risk.

Tramadol has been shown to cross the placental barrier, with an umbilical vein to maternal vein serum concentration ratio of 0.83. A case of tramadol withdrawal in a neonate has been reported following long-term analgesic treatment of the mother. At 35 hours of age, the infant showed signs of a severe withdrawal syndrome with high-pitched crying, trembling, and shortened sleeping hours.

Tramadol Breastfeeding Warnings

Tramadol is excreted into human milk in small amounts. The manufacturer suggests that tramadol should not be administered to nursing women.

Tramadol Side Effects

Brand Names: ConZip, Rybix ODT, Ryzolt, Ultram, Ultram ER

Please note - some side effects for Tramadol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Tramadol - for the Consumer

Tramadol/Acetaminophen

All medicines may cause side effects, but many people have no, or minor, side effects.Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Tramadol/Acetaminophen:

Constipation; diarrhea; dizziness; drowsiness; increased sweating; loss of appetite; nausea.

Seek medical attention right away if any of these SEVERE side effects occur when using Tramadol/Acetaminophen:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest pain; confusion; difficult or painful urination; disorientation; excessive sweating; fainting; fast or irregular heartbeat; fever; hallucinations; loss of coordination; mental or mood changes (eg, agitation, depression); red, swollen, blistered, or peeling skin; seizures (convulsions); severe nausea, vomiting, or diarrhea; severe or persistent headache or dizziness; slow or shallow breathing; suicidal thoughts or behaviors; symptoms of liver problems (eg, yellowing of the eyes or skin, pale stools, dark urine, persistent loss of appetite); tremor; unusual tiredness or weakness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Tramadol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Tramadol:

Constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; indigestion; mild itching; nausea; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Tramadol:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); agitation; chest pain; confusion; difficult or painful urination; disorientation; excessive sweating; fainting; fast or irregular heartbeat; fever; hallucinations; loss of coordination; mood or mental changes (eg, depression); red, blistered, swollen, or peeling skin; seizures; severe dizziness or light-headedness; severe nausea, vomiting, or diarrhea; severe or persistent headache; slow or shallow breathing; suicidal thoughts or behaviors; tremor; vision problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Tramadol Extended-Release Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Tramadol Extended-Release Capsules:

Constipation; dizziness; drowsiness; dry mouth; headache; increased sweating; loss of appetite; mild itching; nausea; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Tramadol Extended-Release Capsules:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); burning, numbness, or tingling; chest pain; confusion; difficult or painful urination; disorientation; excessive sweating; fainting; fast or irregular heartbeat; fever; hallucinations; loss of coordination; mood or mental changes (eg, depression, agitation); red, blistered, swollen, or peeling skin; seizures; severe dizziness or light-headedness; severe nausea, vomiting, or diarrhea; severe or persistent headache; slow or shallow breathing; suicidal thoughts or behaviors; tremor; vision problems; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Tramadol Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Tramadol Extended-Release Tablets:

Constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; indigestion; mild itching; nausea; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Tramadol Extended-Release Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); agitation; chest pain; confusion; difficult or painful urination; disorientation; excessive sweating; fainting; fast or irregular heartbeat; fever; hallucinations; loss of coordination; mood or mental changes (eg, depression); red, blistered, swollen, or peeling skin; seizures; severe dizziness or light-headedness; severe nausea, vomiting, or diarrhea; severe or persistent headache; slow or shallow breathing; suicidal thoughts or behaviors; tremor; vision problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Tramadol Orally Disintegrating Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Tramadol Orally Disintegrating Tablets:

Constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; indigestion; mild itching; nausea; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Tramadol Orally Disintegrating Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); agitation; chest pain; confusion; difficult or painful urination; disorientation; excessive sweating; fainting; fast or irregular heartbeat; fever; hallucinations; loss of coordination; mood or mental changes (eg, depression); red, blistered, swollen, or peeling skin; seizures; severe dizziness or light-headedness; severe nausea, vomiting, or diarrhea; severe or persistent headache; slow or shallow breathing; suicidal thoughts or behaviors; tremor; vision problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects are common. Nausea and constipation occur within the first 90 days of therapy in 40% and 46% of treated patients, respectively. Vomiting, diarrhea, dyspepsia, anorexia, flatulence, abdominal pain, and dry mouth have also been reported.

Nervous system

Seizures have been reported in patients receiving the normal recommended dose. The risk for seizures is increased with doses above the recommended range.

Nervous system side effects occur frequently. Dizziness, headache, and somnolence have been reported in more than 25% of treated patients during the first three months of therapy. CNS stimulation, including nervousness, anxiety, tremor, agitation, euphoria, emotional lability and hallucinations, has also been reported. Confusion, sleep disorders, and coordination disturbances have been reported in less than 5% of patients. Seizures have been reported in over 200 cases. Cases of long-lasting delirium have been reported in two elderly patients. A case of serotonin syndrome triggered by tramadol has also been reported.

Dermatologic

Dermatologic side effects including pruritus (11%) have been reported. Rash and urticaria have occurred rarely.

Genitourinary

Genitourinary side effects including urinary retention and urinary frequency have been reported in less than 5% of treated patients.

Cardiovascular

Cardiovascular side effects including tachycardia and orthostatic hypotension have been reported rarely.

Hypersensitivity

The use of tramadol is contraindicated for patients with a history of allergy to any opioid.

Hypersensitivity side effects including anaphylactoid reactions have been reported after first doses of tramadol as well as in patients with a documented history of codeine allergy. Angioedema has been reported rarely.

Other

Other side effects including withdrawal symptoms and, rarely, auditory hallucinations have been reported. A case of vocal cord closure has also been reported.

Metabolic

Metabolic side effects including hyponatremia have been reported.

What is tramadol?

Tramadol is a narcotic-like pain reliever.

Tramadol is used to treat moderate to severe pain. Tramadol extended-release is used to treat moderate to severe chronic pain when treatment is needed around the clock.

Tramadol may also be used for other purposes not listed in this medication guide.

Important information about tramadol

You should not take this medication if you are allergic to tramadol, if you have ever been addicted to drugs or alcohol, or if you have ever attempted suicide. Do not take tramadol while you are intoxicated (drunk) or taking any of the following: alcohol or street drugs, narcotic pain medicine, sedatives or tranquilizers, or medicine for depression, anxiety, or mental illness.

Seizures (convulsions) have occurred in some people taking this medicine. Tramadol may be more likely to cause a seizure if you have a history of seizures or head injury, a metabolic disorder, or if you are taking certain medicines such as antidepressants, muscle relaxers, narcotic, or medicine for nausea and vomiting.

Seek emergency medical attention if you think you have used too much of this medicine. A tramadol overdose can be fatal.

Tramadol may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

Do not crush the tramadol tablet. This medicine is for oral (by mouth) use only. Powder from a crushed tablet should not be inhaled or diluted with liquid and injected into the body. Using this medicine by inhalation or injection can cause life-threatening side effects, overdose, or death.

Before taking tramadol

You should not take this medication if you are allergic to tramadol, if you have ever been addicted to drugs or alcohol, or if you have ever attempted suicide.

Do not take tramadol while you are intoxicated (drunk) or taking any of the following:

• alcohol or street drugs;
• narcotic pain medicine;
• sedatives or tranquilizers (such as Valium);
• medicine for depression or anxiety; or
• medicine for mental illness (such as bipolar disorder, schizophrenia).

Seizures have occurred in some people taking tramadol. Talk with your doctor about your seizure risk, which may be higher if you have:

• a history of drug or alcohol addiction;
• a history of epilepsy or other seizure disorder;
• a history of head injury;
• a metabolic disorder; or
• if you are also taking an antidepressant, muscle relaxer, narcotic, antipsychotic, or medicine for nausea and vomiting.

To make sure you can safely take tramadol, tell your doctor if you have any of these other conditions:

• kidney disease (or if you are on dialysis);
• cirrhosis or other liver disease;
• a stomach disorder; or
• a history of depression, mental illness, or thoughts of suicide.

Tramadol may be habit forming and should be used only by the person it was prescribed for. Never share tramadol with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether tramadol will harm an unborn baby. Tramadol may cause serious or fatal side effects in a newborn if the mother uses this medication during pregnancy or labor. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Tramadol can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking tramadol. Do not give this medication to anyone younger than 16 years old without the advice of a doctor.