Is Tramadol dangerous for your health ?

  • what is tramadol?
  • What is the dose to take in case of pain?
  • What are the effects on the ability to drive and use machines?
  • when not to use this medicine?
  • Warning and precautions for use
  • Taking alcohol during treatment is not recommended.
  • Mechanism of action: how does it work?
  • Interactions: Do not take this medicine with …
  • How to react in case of overdose?
  • What are the effects of tramadol on pregnancy, breastfeeding and fertility?
  • What are the possible side effects of TRAMADOL?

what is tramadol?

Tramadol is a synthetic molecule that acts like morphine. This is a simplified form, about eight times less powerful. It has a painkiller action. This opioid substance is useful for relieving moderate to severe pain, whether chronic or acute. For example, it can be used for lower back pain or lumbago (pain in the lower back) or shingles in the acute phase.

Tramadol is a level II analgesic that acts on the central nervous system and the drugs that contain it can only be prescribed. This weak opiate analgesic is often associated with Level I analgesics (especially paracetamol) to combine their complementary actions.

What is the dose to take in case of pain?

The dose should be adapted to the intensity of the pain and the individual sensitivity of each patient. The minimum effective dosage should generally be used.

This medication should not be given for longer than absolutely necessary. If long-term pain management with this medication is necessary, given the nature and severity of the disease, careful and regular monitoring (including therapeutic breaks, if necessary) to to check whether and to what extent continuation of treatment is necessary.

  • Acute pain :The loading dose is 100 mg (2 tablets) followed by 50 or 100 mg (1 or 2 tablets) every 4 to 6 hours without exceeding 400 mg / 24 h (8 tablets).
  • Chronic pain :The loading dose is 50 or 100 mg (1 or 2 tablets) followed by 50 or 100 mg (1 or 2 tablets) every 4 to 6 hours without exceeding 400 mg / 24 h (8 tablets).
  • Pediatric population :This medicine is not suitable for children under 15 years of age (see Contraindications section).
  • Elderly patients :No dosage adjustment is generally required in patients younger than 75 years of age in the absence of clinically proven hepatic or renal impairment. In patients older than 75 years, the elimination of the product may be delayed. Therefore, the interval between doses should be extended, if necessary, according to the needs of the patient.
  • Renal failure / dialysis and hepatic insufficiency :The elimination of tramadol is delayed in patients with renal and / or hepatic impairment. In these patients, an increase in the interval between doses should be considered according to the needs of the patient.

What are the effects on the ability to drive and use machines?

Even when taken in accordance with the recommendations, TRAMADOL may cause effects such as drowsiness, blurred vision, dizziness, and may therefore reduce the reactions of vehicle drivers and machine users. This consideration applies especially in case of association with alcohol or other psychotropic drugs.

when not to use this medicine?

TRAMADOL is contraindicated:

  • in case of hypersensitivity to the active substance or to any of the excipients listed under Composition. ;
  • during acute intoxications by alcohol, hypnotics, analgesics, opioids or other psychotropic substances;
  • in patients treated concurrently or who have been treated within the previous 14 days with MAO inhibitors, including linezolid and methylene blue (see Contraindications section).
  • in case of severe respiratory failure;
  • in children under 15;
  • in epilepsy not controlled by treatment (see Warnings and Precautions) section
  • in the withdrawal treatment of drug addicts.
  • This medicine should not usually be used:
  • during pregnancy.

Warning and precautions for use

TRAMADOL should be used with caution in opioid-dependent patients, in patients prone to seizures or in patients with head trauma, shock, impairment of consciousness without obvious cause, central or peripheral disorders of the function respiratory or increased intracranial pressure.

In opioid-dependent patients and in patients with a history of abuse or dependence, treatment should be short-term and under strict medical supervision.

Tramadol is not suitable for substitution treatment in patients with opioid dependence. Although it is an opioid agonist, tramadol can not correct withdrawal symptoms of opioids.

Tolerance, as well as physical and mental dependence can occur especially after long-term use. The clinical need for analgesic therapy should be reassessed regularly (see Dosage and Administration section). Cases of dependence and abuse have been reported (see section Undesirable effects).

Withdrawal symptoms similar to those observed during opioid withdrawal may occur even at therapeutic doses and for short-term treatment (see section Undesirable effects). Withdrawal symptoms can be avoided by gradually decreasing the doses at the time of discontinuation of treatment, especially after long periods of treatment.

If treatment with tramadol is interrupted, it is advisable to gradually reduce the dose to avoid withdrawal symptoms.

Special attention should be paid when treating patients with respiratory failure or those treated with central depressants (see section Interactions with other drugs and other forms of interaction.), or if the recommended dose is largely exceeded (see section Overdose). a risk of respiratory depression can not be ruled out in these situations.

The combination of tramadol with the agonist antagonists of morphine (buprenorphine, nalbuphine, pentazocine) and carbamazepine is not recommended (see section Interactions with other drugs and other forms of interaction.).

Taking alcohol during treatment is not recommended.

Seizures have been reported in patients receiving tramadol at the recommended doses. The risk of seizures increases if doses of tramadol hydrochloride exceed the upper limit of the recommended daily dose (400 mg tramadol hydrochloride). In addition, tramadol may increase the risk of seizures in patients taking other drugs that lower the seizure threshold (see section Interactions with other medicinal products and other forms of interaction). Patients with epilepsy or who may experience seizures should be treated with tramadol only when absolutely necessary.

Metabolism by CYP2D6: Tramadol is metabolized via the liver enzyme CYP2D6. In the case of a deficit or total absence of this enzyme in the patient, the expected analgesic effect may not be obtained. It is estimated that up to 7% of the Caucasian population may have this deficit. However, if the patient is a high-speed metabolizer, there is a risk, even at the recommended dose, of evidence of adverse effects related to opioid toxicity.

General symptoms of opioid toxicity include mental confusion, drowsiness, shallow breathing, contracted pupils, nausea, vomiting, constipation, and loss of appetite. In severe cases, patients may experience life-threatening symptoms of circulatory and respiratory failure that can lead to fatal outcomes in very rare cases.


Postoperative use in children: The literature reports cases of tramadol administered to children after surgery for tonsillectomy and / or adenoidectomy in the treatment of obstructive sleep apnea, resulting in rare but potentially fatal adverse effects. Administration of tramadol to children for postoperative pain relief should be treated with extreme caution and should be accompanied by close monitoring of symptoms related to opioid toxicity, including respiratory depression.

Children with impaired respiratory function: Tramadol is not recommended for use in children with impaired respiratory function, including neuromuscular insufficiency, severe heart or respiratory disease, upper respiratory tract or lung infections, multiple trauma, or surgical procedures. heavy. These factors may exacerbate the symptoms of opioid toxicity.

Risk associated with the concomitant use of opioids: Concomitant use of TRAMADOL with opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescription of sedative drugs such as benzodiazepines or related drugs such as TRAMADOL with opioids should be reserved for patients for whom other treatment options are not possible. If the decision is made to prescribe TRAMADOL at the same time as opioids, the lowest effective dose should be used and the duration of treatment should be as short as possible (see also the general recommendation for dosing in the Dosage and Methodology section) administration.

Patients should be closely monitored for signs or symptoms of respiratory depression and sedation. In this regard, it is strongly recommended that patients and their carers (if applicable) be advised to pay attention to these symptoms (see section Interactions with other medicinal products and other forms of interaction).

Precautions for use :

  • Tramadol should only be used after careful evaluation of the benefit / risk ratio, depending on the origin of the pain and the patient’s profile (see section Preclinical safety data).
  • tramadol should be used with caution in the elderly patient because of the risk of falling and loss of consciousness;
  • this medicine contains less than 1 mmol (23 mg) of sodium per tablet, ie it is essentially “sodium-free”.

Mechanism of action: how does it work?

Tramadol is a centrally acting opioid analgesic. It is a partial and non-selective agonist of morphine, delta and kappa receptors with higher affinity for mu receptors. Other mechanisms that contribute to the analgesic effects of the product are inhibition of neuronal reuptake of norepinephrine and increased serotonin release.

Tramadol has an antitussive effect. Unlike morphine, a wide range of analgesic doses of tramadol have no depressive effect on the respiratory tract. Gastrointestinal motility is also not influenced. The effects on the cardiovascular system tend to be low. The power of tramadol would be 1/10 to 1/6 of that of morphine.

Pediatric population : The effects of oral or parenteral administration of tramadol have been studied in clinical trials involving more than 2,000 children (neonates at 17 years of age). The indications studied in these trials included the treatment of postoperative pain (mainly abdominal surgery), pain after dental surgery or following fractures, burns, trauma and other painful situations that may require treatment. analgesic for at least 7 days.

At doses up to 2 mg / kg once daily or 8 mg / kg daily, in multiple doses (without exceeding the maximum dose of 400 mg daily), the efficacy of tramadol was superior to that of placebo and greater than or equal to that of paracetamol, nalbuphine, pethidine or low dose morphine. These tests confirmed the efficacy of tramadol. The safety profile of tramadol was similar in adult patients and pediatric patients older than one year (see section Posology and method of administration).

Interactions: Do not take this medicine with…

To date, pharmacokinetic studies have shown that concomitant or prior administration of cimetidine (enzyme inhibitor) is unlikely to cause clinically relevant interactions.

Drugs that cause serotonin syndrome

Tramadol may cause seizures and increase the seizure potential of selective serotonin reuptake inhibitors (SSRIs), serotonin and adrenaline inhibitors (SSRIs), tricyclic antidepressants, antipsychotics, and other drugs that lower the threshold of seizures (such as bupropion, mirtazorba, tetrachlorhydrate).

Concomitant use of tramadol with serotoninergic products, such as selective serotonin reuptake inhibitors (SSRIs), serotonin reuptake inhibitors and adrenaline (SSRIs), MAO inhibitors (see Contraindications section), tricyclic antidepressants and mirtazapine may cause serotonin syndrome tremor, confusion or coma.

Interruption of serotoninergic products usually leads to rapid improvement. Treatment depends on the type and severity of the symptoms.

Other drugs known to inhibit CYP3A4, such as ketoconazole and erythromycin, may inhibit the metabolism of tramadol (N-demethylation) and probably also the metabolism of the O-demethylated active metabolite. The clinical significance of such an interaction has not been studied (see the side effects section).

Drugs lowering the epileptogenic threshold

The joint use of proconvulsive drugs, or the lowering of the epileptogenic threshold, must be carefully weighed, because of the seriousness of the risk involved. These drugs are represented by most antidepressants (imipramines, selective serotonin reuptake inhibitors), neuroleptics (phenothiazines and butyrophenones), mefloquine, chloroquine, bupropion, tramadol and fluoroquinolones.

Sedative drugs

It must be remembered that many drugs or substances may add depressant effects to the central nervous system and help reduce alertness. They are derivatives of morphine (analgesics, antitussives and substitution treatments), neuroleptics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines (eg meprobamate), baclofen and thalidomide.

Associations advised against

Antagonists of morphine agonists (buprenorphine, nalbuphine, pentazocine)

Decrease of the analgesic effect by competitive blocking of the receptors, with the risk of appearance of a withdrawal syndrome.

Alcohol (drink or excipient)

Alcohol reinforcement of the sedative effect of opioid analgesics.

Reduced vigilance can make driving dangerous and the use of dangerous machinery.

Avoid taking alcoholic beverages and drugs containing alcohol.


Risk of decreased plasma concentrations of tramadol.

Simultaneous or prior administration of carbamazepine (enzyme inducer) may reduce the analgesic effects and shorten the duration of action of tramadol.

MAOI reversible, including linezolid and methylene blue

Risk of serotonin syndrome: diarrhea, tachycardia, sweating, tremors, confusion or coma.

If the association can not be avoided, very close clinical monitoring. Start the combination at the recommended minimum doses.

Morphic partial antagonist

Risk of reduction of the analgesic effect.


Risk of reduction of the analgesic effect.

Sodium oxybate

Increase of the central depression.

Reduced vigilance can make driving dangerous and the use of dangerous machinery.

Associations subject to precautions for use

Antivitamin K

Risk of increase in the effect of antivitamin K and risk of bleeding. More frequent control of the INR. Possible adaptation of the dosage of antivitamin K during treatment with tramadol and after discontinuation of treatment.

Associations to take into account

Other morphine-type opioid analgesics, morphine-type antitussives (dextromethorphan, noscapine, pholcodine), morphine antitussives (codeine, ethylmorphine)

Increased risk of respiratory depression that can be fatal in case of overdose.

Other drugs lowering the epileptogenic threshold

Increased risk of convulsions.

Other sedative drugs

Increase of the central depression.

Reduced vigilance can make driving dangerous and the use of dangerous machinery.

Benzodiazepines and related

Increased risk of respiratory depression that can be fatal in case of overdose.


Increased risk of respiratory depression that can be fatal in case of overdose.

MAO-B inhibitors

Risk of developing a serotonin syndrome.

Selective serotonin reuptake inhibitors (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline)

Risk of seizures and / or serotonin syndrome.


Risk of seizures and / or serotonin syndrome.


Increased plasma concentrations of tramadol by decreased hepatic metabolism of bupropion. In addition, the risk of seizures by adding effects of both drugs.


Decreased intensity and duration of the analgesic effect of tramadol and risk of decreased antiemetic effect of ondansetron.


Concomitant use of sedating drugs such as benzodiazepines or related drugs such as TRAMADOL with opioids increases the risk of sedation, respiratory depression, coma and death due to a cumulative CNS depressive effect. The dosage and duration of concomitant use should be limited (see Warnings and Precautions section).

How to react in case of overdose?


In principle, during tramadol poisoning, symptoms similar to those caused by other centrally acting analgesics (opioids) are expected. These include, but are not limited to, miosis, vomiting, cardiovascular collapse, disturbances of consciousness to coma, convulsions and respiratory depression until respiratory arrest.


Take the usual general emergency measures. Ensure freedom of the airways (aspiration), maintain ventilation and circulation according to symptoms. The antidote for respiratory depression is naloxone. In animal experiments, naloxone had no effect on convulsions. In such cases, diazepam should be administered intravenously.

In case of intoxication by oral forms, gastrointestinal elimination with active charcoal or gastric lavage is recommended only within 2 hours after taking tramadol. After this period, gastrointestinal decontamination may be useful in cases of intoxication with unusually high amounts of tramadol or sustained release forms.

Tramadol is a serum that is very weakly purified by hemodialysis or haemofiltration. Therefore, treatment of acute TRAMADOL intoxication with hemodialysis or haemofiltration alone is not appropriate for detoxification.

What are the effects of tramadol on pregnancy, breastfeeding and fertility?

the effects of tramadol on pregnancy: studies in animals using tramadol have shown very significant effects on organ development, ossification and neonatal mortality. Teratogenic effects have not been demonstrated. Tramadol crosses the placental barrier. There is insufficient evidence regarding the safety of tramadol during pregnancy in humans. TRAMADOL should not be used in pregnant women.

Administered before or during delivery, tramadol does not affect uterine contractility.

Tramadol may cause changes in respiratory rate in neonates, which generally do not have adverse clinical consequences. Prolonged use during pregnancy may result in withdrawal syndrome in the newborn.

the effects of tramadol on breastfeeding: About 0.1% of the tramadol dose given to the mother is excreted in breast milk. In the immediate postnatal period, a daily oral dose of up to 400 mg of maternal tramadol corresponds to an average amount of tramadol ingested by the breastfed infant, representing 3% of the maternal dose adjusted to body weight. For example, tramadol should not be used during breastfeeding, or breastfeeding should be interrupted during treatment with tramadol. Stopping breastfeeding is usually not necessary after a single dose of tramadol.

the effects of tramadol on fertility: Postmarketing studies showed no effect of tramadol on fertility. Studies in animals have shown no effect of tramadol on fertility.

What are the possible side effects of TRAMADOL?

Neuropsychia, Confusion, Hallucination, Delirium, Seizures, Nausea, Vomiting, Drowsiness, Headache, Dizziness, Hypersudation, Feeling of discomfort, Dry mouth, Constipation, Pain, Abdomen, Skin, Asthenia, Euphoria, Vision disorders, Tachycardia, Hypotension, Palpitations, elevation of blood pressure, anaphylactic reaction, urticaria, allergy, angioedema, bronchospasm, anaphylactic shock, dysuria, respiratory disorders, respiratory disorders, respiratory depression, opioid dependence, withdrawal syndrome, withdrawal syndrome, insomnia , mental disorders Gastrointestinal symptoms, intestinal, panic attack, anxiety, paresthesia, tinnitus and increased liver enzyme

The most commonly reported adverse reactions are nausea and dizziness, seen in more than 10% of patients.

The frequencies are defined as follows:

  • very common: ≥ 1/10;
  • frequent: ≥ 1/100 to <1/10;
  • uncommon: ≥ 1/1000 to <1/100;
  • rare: ≥ 1/10 000 to <1/1000;
  • very rare: <1/10 000;
  • indeterminate frequency: can not be estimated from the available data.

Rare immune system disorders: allergic reactions (eg, dyspnoea, bronchospasm, whistling, angioedema) and anaphylaxis.

Rare psychiatric conditions: hallucinations, confusion, trouble sleeping, delirium, anxiety and nightmares. After administration of TRAMADOL, various psychic side effects may also be observed, the intensity and nature of which vary from one patient to another (depending on the individual’s responsiveness and duration of treatment). Mood disorders (usually exhilaration, sometimes dysphoria), changes in activity (usually reduced, sometimes even intensified) and impaired cognitive and sensory abilities (eg, decision-making, perceptual disorders).

Cases of abuse and addiction have been reported, as well as cases of withdrawal syndrome.

Withdrawal symptoms, similar to those seen during opioid withdrawal, may occur such as agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor, and gastrointestinal symptoms.

Other withdrawal symptoms have been reported very rarely, including: panic attack, severe anxiety, hallucinations, paresthesia, tinnitus, other central nervous system disorders (confusion, delusions, depersonalization, derealization, paranoia).

Rare disorders of the nervous system: paresthesia, tremors, convulsions, involuntary muscle contractions, abnormal coordination, syncope, speech disorder.

Seizures occurred mainly after high doses of tramadol or concomitant treatment with drugs that could lower the seizure threshold (see Warnings and Precautions and Interactions with Other Drugs and Other Warnings). other forms of interaction).

Not known frequency: loss of consciousness.

Very common: vertigo.

Common: headache, drowsiness.

Rare metabolism and nutrition disorders: change your appetite.

Unknown: hypoglycemia.

Rare visual disorders: myosis, blurred vision, mydriasis.

Rare heart diseases: bradycardia.

Uncommon: effects on cardiovascular regulation (palpitations, tachycardia). These side effects can occur especially after intravenous administration and in patients under physical stress.

Uncommon vascular disorders: effects on cardiovascular regulation (orthostatic hypotension or cardiovascular collapse). These side effects can occur especially after intravenous administration and in patients under physical stress.

Rare respiratory, thoracic and mediastinal disorders: respiratory depression, dyspnea.

Respiratory depression may occur if doses administered are well in excess of the recommended doses and other central depressant drugs are concomitantly administered (see section Interactions with other drugs and other forms of interaction).

A worsening of asthma has also been reported, although no cause-and-effect relationship has been observed.

Gastrointestinal disorders:

Very common: nausea.

Common: constipation, dry mouth, vomiting.

Uncommon: gagging, gastrointestinal discomfort (feeling of heaviness, flatulence), diarrhea.

Rare hepatobiliary disorders: In a few isolated cases, an increase in liver enzymes has been reported during the therapeutic use of tramadol.

Skin disorders and subcutaneous tissues:

Frequent: hyperhidrosis.

Uncommon: skin reactions (pruritus, rash, urticaria, etc.).

Rare musculoskeletal and systemic disorders: muscular weakness.

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