What are the most common side effects of tramadol. How can you manage headaches caused by tramadol. When should you seek medical attention for tramadol side effects. What are the signs of a serious allergic reaction to tramadol.

Understanding Tramadol: Uses and Potential Side Effects

Tramadol is a powerful pain medication prescribed for moderate to severe pain. While effective, it’s important to be aware of potential side effects. This comprehensive guide explores both common and serious side effects of tramadol, offering practical advice on managing them and knowing when to seek medical attention.

Very Common Side Effects of Tramadol

Tramadol can cause side effects in some people, with certain reactions occurring more frequently than others. The most common side effects, affecting more than 1 in 10 people, include:

• Nausea
• Dizziness

These effects, while unpleasant, are generally not cause for major concern. However, if they persist or become severe, it’s advisable to consult your healthcare provider.

Common Side Effects and Management Strategies

Beyond the very common side effects, tramadol can cause a range of other reactions in more than 1 in 100 people. Let’s explore these common side effects and strategies to manage them effectively:

Dealing with Tramadol-Induced Headaches

Headaches are a frequent complaint among tramadol users. How can you manage this side effect?

• Rest and hydration: Ensure you’re getting enough rest and drinking plenty of fluids.
• Avoid alcohol: Combining tramadol with alcohol can increase the likelihood of side effects, including headaches.
• Over-the-counter pain relievers: Consult your pharmacist about suitable painkillers to alleviate headaches.

Generally, tramadol-induced headaches should subside within the first week of treatment. If they persist beyond this period or become severe, it’s crucial to inform your doctor.

Combating Fatigue and Dizziness

Feeling sleepy, tired, dizzy, or “spaced out” is another common side effect of tramadol. How can you cope with these symptoms?

• Give it time: These effects often diminish within 1-2 weeks as your body adjusts to the medication.
• Avoid alcohol: Drinking can exacerbate feelings of tiredness and dizziness.
• Consult your doctor: If these symptoms persist beyond two weeks, discuss potential adjustments to your treatment plan.

Managing Nausea and Vomiting

Gastrointestinal distress is a frequent complaint among tramadol users. What strategies can help alleviate nausea and vomiting?

• Dietary adjustments: Stick to simple, bland meals and avoid rich or spicy foods.
• Timing: Try taking tramadol after eating a meal or snack.
• Hydration: If vomiting occurs, maintain hydration with small, frequent sips of water.
• Medication: Your doctor may prescribe anti-nausea medication if symptoms persist.

It’s important to note that severe vomiting or diarrhea lasting more than 24 hours can impact the effectiveness of oral contraceptives. If you’re using birth control pills, consult the package insert or your healthcare provider for guidance.

Alleviating Tramadol-Induced Constipation

Constipation is a common side effect of many opioid medications, including tramadol. How can you prevent or relieve this uncomfortable symptom?

• Increase fiber intake: Incorporate more fresh fruits, vegetables, and whole grains into your diet.
• Stay hydrated: Aim to drink several glasses of water or non-alcoholic beverages daily.
• Gentle exercise: Light physical activity, such as short walks or swimming, can help stimulate bowel movements.
• Laxatives: If lifestyle changes aren’t sufficient, your doctor may recommend laxatives or stool softeners.

Coping with Dry Mouth

Dry mouth, while not typically serious, can be uncomfortable. What remedies can provide relief?

• Sugar-free gum or candies: These can stimulate saliva production.
• Artificial saliva substitutes: Your doctor may prescribe sprays, gels, or lozenges to keep your mouth moist.
• Stay hydrated: Regular sips of water can help combat dry mouth.

Addressing Excessive Sweating

Some tramadol users experience increased sweating. How can you manage this side effect?

• Wear breathable clothing: Choose loose, light fabrics that allow air circulation.
• Use antiperspirants: Opt for strong, clinical-strength formulations.
• Environmental control: Use fans or air conditioning when possible to stay cool.

If sweating becomes unbearable, consult your doctor about potential alternative pain management options.

Combating Low Energy Levels

Feeling fatigued or low on energy is a common complaint among tramadol users. What can be done to address this?

• Discuss with your doctor: They may be able to adjust your dosage or consider alternative pain medications.
• Maintain a healthy lifestyle: Regular exercise, a balanced diet, and good sleep hygiene can help boost energy levels.
• Consider supplements: After consulting your doctor, certain vitamins or supplements might help combat fatigue.

Recognizing Serious Side Effects of Tramadol

While less common, tramadol can cause serious side effects in some individuals. It’s crucial to be aware of these potential reactions and know when to seek immediate medical attention.

Signs of Serious Side Effects

Contact your doctor or call 111 immediately if you experience any of the following:

• Dizziness, fatigue, and low energy (possible signs of low blood pressure)
• Hallucinations (seeing or hearing things that aren’t there)
• Confusion
• Extreme drowsiness
• Difficulty urinating or inability to urinate

Emergency Situations Requiring Immediate Action

Call 999 or go to A&E immediately if you or someone taking tramadol experiences:

• Seizures or fits
• Breathing difficulties or shallow breathing

Understanding and Responding to Allergic Reactions

While rare, severe allergic reactions (anaphylaxis) to tramadol can occur. Recognizing the signs of a serious allergic reaction is crucial for ensuring prompt medical intervention.

Signs of a Serious Allergic Reaction

Call 999 immediately if you notice any of the following symptoms:

• Sudden swelling of the lips, mouth, throat, or tongue
• Rapid or labored breathing (wheezing, choking, or gasping for air)
• Tightness in the throat or difficulty swallowing
• Skin, tongue, or lips turning blue, grey, or pale (may be more noticeable on the palms or soles in individuals with darker skin tones)
• Sudden confusion, drowsiness, or dizziness
• Loss of consciousness
• In children: limpness, unresponsiveness, or difficulty focusing

You may also notice a swollen, raised, itchy, blistered, or peeling rash. These symptoms could indicate a severe allergic reaction requiring immediate hospital treatment.

Additional Considerations and Precautions

While this guide covers many common and serious side effects of tramadol, it’s not exhaustive. Always refer to the leaflet inside your medication packet for a complete list of potential side effects.

Reporting Side Effects

The medical community relies on patient feedback to better understand medication side effects. How can you contribute to this important process?

• Use the Yellow Card Scheme: This UK-based system allows patients and healthcare professionals to report suspected side effects.
• Report online: Visit the Yellow Card website or use their mobile app for convenient reporting.
• Provide detailed information: Include as much information as possible about the side effect, when it occurred, and any other relevant details.

By reporting side effects, you play a crucial role in improving medication safety for all patients.

Tramadol and Pain Management: A Balanced Approach

While tramadol can be an effective tool for managing moderate to severe pain, it’s essential to weigh its benefits against potential side effects. How can you ensure you’re using tramadol safely and effectively?

• Open communication: Maintain an ongoing dialogue with your healthcare provider about your pain levels and any side effects you experience.
• Follow prescribing instructions: Take tramadol exactly as directed by your doctor.
• Regular check-ins: Schedule follow-up appointments to assess the effectiveness of your pain management plan.
• Consider alternatives: Discuss non-opioid pain management strategies with your doctor, such as physical therapy, acupuncture, or other medications.

Remember, effective pain management often involves a multifaceted approach. Tramadol may be just one component of a comprehensive treatment plan tailored to your individual needs.

Navigating Tramadol Use in Special Populations

Certain groups may be more susceptible to tramadol side effects or require special considerations when using this medication. Who should exercise extra caution when taking tramadol?

Elderly Patients

Older adults may be more sensitive to tramadol’s effects. What precautions should be taken?

• Lower starting doses: Doctors often prescribe lower initial doses for elderly patients.
• Closer monitoring: Regular check-ins to assess side effects and medication effectiveness are crucial.
• Fall risk: Be aware of increased fall risk due to dizziness or drowsiness.

Patients with Liver or Kidney Disease

Tramadol is processed by the liver and excreted through the kidneys. How does this impact patients with impaired organ function?

• Dose adjustments: Your doctor may need to adjust your tramadol dosage based on your liver and kidney function.
• More frequent monitoring: Regular blood tests may be necessary to ensure safe use of the medication.
• Alternative pain management strategies: In some cases, other pain relief options may be more appropriate.

Pregnant and Breastfeeding Women

The use of tramadol during pregnancy and breastfeeding requires careful consideration. What should expectant or nursing mothers know?

• Pregnancy risks: Tramadol use during pregnancy may be associated with certain risks to the fetus. Discuss the potential benefits and risks with your healthcare provider.
• Breastfeeding concerns: Tramadol can pass into breast milk. Your doctor will help weigh the benefits of pain relief against potential risks to the nursing infant.
• Alternative pain management: Non-opioid pain relief options may be preferable for pregnant or breastfeeding women when possible.

Always consult your healthcare provider for personalized advice regarding tramadol use in these special circumstances.

Long-Term Use of Tramadol: Benefits and Risks

While tramadol can be an effective pain management tool, long-term use requires careful consideration. What are the potential benefits and risks of extended tramadol use?

Benefits of Long-Term Tramadol Use

• Consistent pain relief: For some patients, tramadol provides ongoing management of chronic pain conditions.
• Improved quality of life: Effective pain control can enhance daily functioning and overall well-being.
• Lower risk of addiction: Compared to some other opioids, tramadol may have a lower potential for addiction when used as prescribed.

Risks and Considerations for Long-Term Use

• Tolerance: Over time, some patients may require higher doses to achieve the same pain-relieving effect.
• Physical dependence: Long-term use can lead to physical dependence, making it challenging to discontinue the medication.
• Increased side effect risk: Some side effects may become more pronounced or problematic with extended use.
• Drug interactions: Long-term tramadol use may interact with other medications, requiring careful management.

If you’re considering long-term tramadol use, work closely with your healthcare provider to develop a comprehensive pain management plan that balances effectiveness with safety.

Tramadol Alternatives: Exploring Other Pain Management Options

While tramadol can be effective for many patients, it’s not the only option for pain management. What alternatives might be worth considering?

Non-Opioid Medications

• NSAIDs (Nonsteroidal anti-inflammatory drugs): Such as ibuprofen or naproxen, can be effective for various types of pain.
• Acetaminophen (Paracetamol): Often used for mild to moderate pain relief.
• Gabapentin or Pregabalin: These medications can be particularly helpful for nerve pain.

Non-Pharmacological Approaches

• Physical therapy: Can help improve mobility and reduce pain in many conditions.
• Acupuncture: Some patients find relief through this traditional Chinese medicine practice.
• Cognitive Behavioral Therapy (CBT): Can help manage chronic pain by addressing thought patterns and behaviors.
• Exercise and stretching: Regular physical activity can help manage certain types of pain.

Interventional Procedures

• Nerve blocks: Injections that can provide targeted pain relief for specific areas.
• Radiofrequency ablation: A procedure that uses heat to disrupt pain signals from specific nerves.
• Spinal cord stimulation: An implanted device that can help manage chronic pain in some patients.

Remember, the most effective pain management approach often involves a combination of treatments tailored to your specific needs and condition. Discuss these options with your healthcare provider to determine the best course of action for your situation.

Side effects of tramadol – NHS

Like all medicines, tramadol can cause side effects, although not everyone gets them. Talk to your doctor or pharmacist if the side effects listed below bother you or do not go away.

Very common side effects

Very common side effects of tramadol happen in more than 1 in 10 people and include:

• feeling sick
• feeling dizzy

Common side effects

These common side effects of tramadol happen in more than 1 in 100 people. There are things you can do to help cope with them.

Headaches

Make sure you rest, and drink plenty of fluids. It’s best not to drink alcohol with tramadol as you’re more likely to get side effects, like feeling sleepy. Ask your pharmacist to recommend a painkiller. Headaches should usually go away after the first week of taking tramadol. Talk to your doctor if they last longer than a week or are severe.

Feeling sleepy, tired, dizzy or “spaced out”

These side effects should wear off within a week or two as your body gets used to tramadol. Talk to your doctor if they carry on for longer. Do not drink any alcohol as this will make you feel more tired.

Feeling or being sick (nausea or vomiting)

Stick to simple meals and do not eat rich or spicy food. It might help to take your tramadol after you’ve eaten a meal or snack. If you’re being sick, try small frequent sips of water. Speak to a pharmacist if you have signs of dehydration, such as peeing less than usual or having dark, strong-smelling pee.

If tramadol continues to make you sick, or feel sick, tell your doctor. They may be able to prescribe a medicine which can also protect your stomach. If tramadol makes you vomit or have severe diarrhoea for more than 24 hours, your contraceptive pills may not protect you from pregnancy. Check the pill packet to find out what to do.

Constipation

Try to get more fibre into your diet such as fresh fruit and vegetables and cereals. Also try to drink several glasses of water, or another non-alcoholic drink, every day. If you can, it may also help to do some gentle exercise like swimming or going for a short walk.

Speak to your doctor about medicine to help prevent or treat constipation caused by tramadol if your symptoms do not go away.

Dry mouth

Try chewing sugar-free gum or sucking sugar-free sweets. Your doctor may also prescribe an artificial saliva substitute to keep your mouth moist. This comes as a spray, gel or lozenge.

Sweating

Try wearing loose clothing, using a strong anti-perspirant and using a fan, if possible. If this does not help and you find it unbearable, speak to your doctor as you may need to be treated with a different type of painkiller.

Low energy

Speak to your doctor as they may be able to adjust your dose or give you a different painkiller.

Serious side effects

Serious side effects happen in less than 1 in 100 people.

Call your doctor or call 111 now if you:

• feel dizzy, tired and have low energy – these can be a sign of low blood pressure
• have hallucinations (seeing or hearing things that are not there)
• feel confused
• feel very sleepy
• have trouble peeing or you cannot pee at all

Immediate action required: Call 999 or go to A&E now if you or your child:

• have a seizure or fit
• have breathing difficulties or short shallow breathing

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction (anaphylaxis) to tramadol.

Immediate action required: Call 999 now if:

• your lips, mouth, throat or tongue suddenly become swollen
• you’re breathing very fast or struggling to breathe (you may become very wheezy or feel like you’re choking or gasping for air)
• your throat feels tight or you’re struggling to swallow
• your skin, tongue or lips turn blue, grey or pale (if you have black or brown skin, this may be easier to see on the palms of your hands or soles of your feet)
• you suddenly become very confused, drowsy or dizzy
• someone faints and cannot be woken up
• a child is limp, floppy or not responding like they normally do (their head may fall to the side, backwards or forwards, or they may find it difficult to lift their head or focus on your face)

You or the person who’s unwell may also have a rash that’s swollen, raised, itchy, blistered or peeling.

These can be signs of a serious allergic reaction and may need immediate treatment in hospital.

Other side effects

These are not all the side effects of tramadol. For a full list, see the leaflet inside your medicine packet.

Information:

You can report any suspected side effect using the Yellow Card safety scheme.

Visit Yellow Card for further information.

Page last reviewed: 19 January 2022

Next review due: 19 January 2025

Tramadol/acetaminophen for the treatment of acute migraine pain: findings of a randomized, placebo-controlled trial

Randomized Controlled Trial

. 2005 Nov-Dec;45(10):1317-27.

doi: 10.1111/j.1526-4610.2005.00264.x.

Stephen D Silberstein 
¹
, Frederick G Freitag, Todd D Rozen, David B Kudrow, David J Hewitt, Donna M Jordan, Alan C Fisher, Norman R Rosenthal; CAPSS-223 Investigators

Affiliations

Affiliation

• ¹ Jefferson Medical College, Philadelphia, PA, USA.

• PMID:

  16324164

• DOI:

  10.1111/j.1526-4610.2005.00264.x

Randomized Controlled Trial

Stephen D Silberstein et al.

Headache.

2005 Nov-Dec.

. 2005 Nov-Dec;45(10):1317-27.

doi: 10.1111/j.1526-4610.2005.00264.x.

Authors

Stephen D Silberstein 
¹
, Frederick G Freitag, Todd D Rozen, David B Kudrow, David J Hewitt, Donna M Jordan, Alan C Fisher, Norman R Rosenthal; CAPSS-223 Investigators

Affiliation

• ¹ Jefferson Medical College, Philadelphia, PA, USA.

• PMID:

  16324164

• DOI:

  10.1111/j.1526-4610.2005.00264.x

Abstract

Objective:

To compare tramadol/acetaminophen (APAP) and placebo for the management of acute migraine pain.

Background:

Tramadol/APAP tablets reduced moderate-to-moderately severe acute pain in controlled studies of other painful conditions.

Methods:

This randomized, double-blind, placebo-controlled, parallel group study enrolled adults with migraine pain as per International Headache Society criteria. Subjects took tramadol/APAP (total dose, 75 mg/650 mg) or placebo for a typical migraine with moderate-to-severe pain. Severity of pain and migraine-related symptoms were recorded before study medication and at 0.5, 1, 2, 3, 4, 6, and 24 hours after study medication.

Results:

Efficacy analyses included 305 subjects (154 tramadol/APAP and 151 placebo). Treatment response was higher for tramadol/APAP than a placebo at 2 hours after dosing (55.8% vs. 33.8%, P < .001) and at every other assessment from 30 minutes (12.3% vs. 6.6%) through 6 hours (64.9% vs. 37.7%) (all P< or = .022). Subjects in the tramadol/APAP group were more likely than those in the placebo group to be pain-free at 2 hours (22.1% vs. 9.3%), 6 hours (42.9% vs. 25.2%), and 24 hours (52.7% vs. 37.9%) (all P< or = .007). Two hours after dosing, moderate-to-severe symptoms that were less common for tramadol/APAP than placebo included photophobia (34.6% vs. 52.2%, P= .003) and phonophobia (34.3% vs. 44.9%, P = .008), but not migraine-related nausea (38.5% vs. 29.4%, P= .681). Treatment-related adverse events included nausea, dizziness, vomiting, and somnolence.

Conclusions:

Tramadol/APAP reduces the severity of pain, photophobia, and phonophobia associated with migraine headache, but does not reduce migraine-associated nausea. Tramadol/APAP might be an appropriate option for the management of moderate-to-severe migraine headache.

Similar articles

• Tramadol 37.5-mg/acetaminophen 325-mg combination tablets added to regular therapy for rheumatoid arthritis pain: a 1-week, randomized, double-blind, placebo-controlled trial.

  Lee EY, Lee EB, Park BJ, Lee CK, Yoo B, Lim MK, Shim SC, Sheen DH, Seo YI, Kim HA, Baek HJ, Song YW.

  Lee EY, et al.
  Clin Ther. 2006 Dec;28(12):2052-60. doi: 10.1016/j.clinthera.2006.12.019.
  Clin Ther. 2006.

  PMID: 17296461

  Clinical Trial.

• Single-dose intravenous tramadol for acute migraine pain in adults: a single-blind, prospective, randomized, placebo-controlled clinical trial.

  Alemdar M, Pekdemir M, Selekler HM.

  Alemdar M, et al.
  Clin Ther. 2007 Jul;29(7):1441-7. doi: 10.1016/j.clinthera.2007.07.017.
  Clin Ther. 2007.

  PMID: 17825695

  Clinical Trial.

• Randomized study of tramadol/acetaminophen versus placebo in painful diabetic peripheral neuropathy.

  Freeman R, Raskin P, Hewitt DJ, Vorsanger GJ, Jordan DM, Xiang J, Rosenthal NR; CAPSS-237 Study Group.

  Freeman R, et al.
  Curr Med Res Opin. 2007 Jan;23(1):147-61. doi: 10.1185/030079906X162674.
  Curr Med Res Opin. 2007.

  PMID: 17257476

  Clinical Trial.

• The ‘Act when Mild’ (AwM) study: a step forward in our understanding of early treatment in acute migraine.

  Goadsby PJ.

  Goadsby PJ.
  Cephalalgia. 2008 Sep;28 Suppl 2:36-41. doi: 10.1111/j.1468-2982.2008.01689.x.
  Cephalalgia. 2008.

  PMID: 18715331

  Review.

• Combination analgesia in 2005 – a rational approach: focus on paracetamol-tramadol.

  Schug SA.

  Schug SA.
  Clin Rheumatol. 2006;25 Suppl 1:S16-21. doi: 10.1007/s10067-006-0202-9. Epub 2006 Jun 2.
  Clin Rheumatol. 2006.

  PMID: 16741784

  Review.

See all similar articles

Cited by

• Acute Treatments for Episodic Migraine in Adults: A Systematic Review and Meta-analysis.

  VanderPluym JH, Halker Singh RB, Urtecho M, Morrow AS, Nayfeh T, Torres Roldan VD, Farah MH, Hasan B, Saadi S, Shah S, Abd-Rabu R, Daraz L, Prokop LJ, Murad MH, Wang Z.

  VanderPluym JH, et al.
  JAMA. 2021 Jun 15;325(23):2357-2369. doi: 10.1001/jama.2021.7939.
  JAMA. 2021.

  PMID: 34128998
  Free PMC article.

• Consensus of the Hellenic Headache Society on the diagnosis and treatment of migraine.

  Kouremenos E, Arvaniti C, Constantinidis TS, Giannouli E, Fakas N, Kalamatas T, Kararizou E, Naoumis D, Mitsikostas DD; Hellenic Headache Society.

  Kouremenos E, et al.
  J Headache Pain. 2019 Dec 13;20(1):113. doi: 10.1186/s10194-019-1060-6.
  J Headache Pain. 2019.

  PMID: 31835997
  Free PMC article.

• Migraine Treatment: Current Acute Medications and Their Potential Mechanisms of Action.

  Ong JJY, De Felice M.

  Ong JJY, et al.
  Neurotherapeutics. 2018 Apr;15(2):274-290. doi: 10.1007/s13311-017-0592-1.
  Neurotherapeutics. 2018.

  PMID: 29235068
  Free PMC article.

  Review.

• [The role of opioids in the treatment of primary headache disorders].

  Totzeck A, Gaul C.

  Totzeck A, et al.
  Schmerz. 2014 Apr;28(2):135-40. doi: 10.1007/s00482-013-1380-4.
  Schmerz. 2014.

  PMID: 24500765

  German.

• Analgesic activity of fixed dose combinations of paracetamol with diclofenac sodium and paracetamol with tramadol on different pain models in healthy volunteers – A randomized double blind crossover study.

  Tripathi S, Shah R, Sharma DC.

  Tripathi S, et al.
  J Anaesthesiol Clin Pharmacol. 2012 Oct;28(4):465-9. doi: 10.4103/0970-9185.101912.
  J Anaesthesiol Clin Pharmacol. 2012.

  PMID: 23225925
  Free PMC article.

See all “Cited by” articles

Publication types

MeSH terms

Substances

Zaldiar in the treatment of migraine attacks | Ekusheva E.

V., Filatova E.G., Golubev V.L.

In the treatment of acute attacks of migraine headache, various analgesics are used: both non-specific non-steroidal anti-inflammatory drugs for migraine and paracetamol, combined analgesics, and ergotamine and triptans with a specific vasoconstrictive action of the meninges. Based on the results of numerous placebo-controlled studies, recommendations have been developed for the use of analgesics of various chemical groups, depending on the severity of a migraine attack. Thus, NSAIDs and paracetamol are recommended for mild and moderate attacks. For severe and very severe attacks, it is advisable to prescribe triptans. With subcutaneous administration of sumatriptan, the therapeutic effect is observed after 2 hours at 79% of cases of seizures, and when taking pills ranges from 45 to 68% [7]. Triptan therapy is currently the most effective treatment for migraine headaches. However, a number of patients have contraindications to their use: uncontrolled arterial hypertension, coronary heart disease, myocardial infarction and stroke in history, peripheral vascular disease of the extremities. Often, unwanted side effects in the form of a feeling of chest pressure, numbness, paresthesia, dizziness also limit their use. Finally, about 30% of seizures are resistant to triptans. Late drug intake and the development of sensitization of neurons of the trigeminal system are discussed as reasons for resistance.

The current trend in the development of new analgesics is to create combinations of analgesics, primarily opioids, with non-steroidal anti-inflammatory drugs. The combination of tramadol / paracetamol (Zaldiar) has important advantages, since the components included in its composition are able to potentiate the analgesic properties of each other, while there is no potentiation of side effects. Paracetamol is one of the most prescribed and safe analgesics. Unlike other NSAIDs, it does not cause damage to the gastric mucosa, does not affect platelet aggregation. According to WHO recommendations, the use of paracetamol in a daily dose of 4.0 g in adults and 60 mg/kg in children is considered safe. Paracetamol is the safest analgesic and is approved for the relief of migraine attacks at all stages of pregnancy. Tramadol is a synthetic opioid analgesic, the pronounced analgesic effect of which is due to the agonistic effect on opioid receptors and inhibition of neuronal reuptake of norepinephrine. At the same time, binding to opiate receptors is 10,000 times weaker than that of morphine. In therapeutic doses, tramadol does not cause respiratory and circulatory depression, gastrointestinal and urinary tract motility disorders. Two tablets of Zaldiar (75 mg of tramadol and 650 of paracetamol) are better tolerated than 2 tablets of tramadol (100 mg) [1]. Controlled studies have been conducted on the use of Zaldiar in acute postoperative pain [6], toothache [1], as well as chronic pain syndromes. Also published the results of a placebo-controlled study on the effectiveness of tramadol/paracetamol in the treatment of migraine attacks [7]. Shown to be comparable to triptans for severe and very severe pain. Nausea, vomiting, dizziness and drowsiness have been noted as unwanted side effects.
The aim of our open study was to investigate the efficacy, tolerability and safety of 1 tablet Zaldiar (37.5 mg tramadol and 325 mg paracetamol) and 2 tablets Zaldiar (75 mg tramadol and 650 mg paracetamol) in the relief of a migraine attack.
Materials and methods
The study included 25 patients with migraine without aura, in whom 2 migraine attacks were stopped with Zaldiar (a total of 50 migraine attacks).
To stop the first migraine attack, 1 tablet of Zaldiar is used at the very beginning of a migraine attack. Repeated administration of the same dose of the drug (1 tablet) with its insufficient effectiveness or the return of the headache after 2 hours.
To stop the second migraine attack, 2 Zaldiar tablets are used immediately at the very beginning of a migraine attack. Repeated administration of the same dose of the drug (2 tablets) with its insufficient effectiveness or the return of a headache – after 6 hours.
With insufficient effectiveness, the patient is allowed to additionally take Zaldiar (the maximum daily dose is 8 tablets) or the usual analgesics.
Results of study
Efficiency
To evaluate the effectiveness of the analgesic action of Zaldiar, two parameters were used: complete relief of pain and improvement/reduction of pain by 50% or more. These parameters were assessed according to patients’ diaries at standard time intervals: 1, 2, 4, 6 hours and 24 hours after taking the drug. In addition, a comparative evaluation of the effectiveness of 1 Zaldiar tablet and 2 tablets at the same time intervals was carried out (Tables 1, 2, Figures 1, 2).
Significant differences when comparing the effectiveness of 1 and 2 tablets of Zaldiar were obtained 2 hours after taking the drug and 24 hours in the percentage of seizures, the intensity of which decreased by half or more.
About 1/3 of the attacks were resistant to Zaldiar and patients were taking other painkillers. When taking 1 tablet to relieve an attack, other analgesic drugs were used in 36% of attacks, and when taking 2 tablets at once, in 24%, however, these differences were not significant.
Headache recurrence: first improvement, and then re-intensification of the pain syndrome from mild – moderate to severe – very severe pain was observed after 4 hours when taking 1 tablet in 36% of attacks, and when taking 2 tablets in 32%; there were no statistically significant differences between taking 1 and 2 tablets. When the headache returned according to the instructions, the patients took an additional dose of Zaldiar. The average number of Zaldiar tablets used in the first attack (one tablet was initially used) was 1.8 tablets, in the second (2 tablets were used at once) – 2.8 tablets.
Effect of Zaldiar on concomitant symptoms
Nausea was the most common symptom accompanying migraine headache in the studied patients. It was observed in all attacks and decreased more slowly than other symptoms. Photo- and phonophobia were noted in more than half of the attacks, and already 1 hour after taking Zaldiar, the percentage of attacks with photo- and phonophobia significantly decreased (Fig. 3).
There were no significant differences in the reduction of concomitant symptoms when taking 1 or 2 Zaldiar tablets.
Influence of Zaldiar on the capacity of patients
In all studied attacks, there was a violation of the capacity of patients: 42% of the attacks caused a moderate impairment of capacity; significant – 22%; 36% required bed rest. Recovery after taking Zaldiar is shown in Figure 4.
There were no significant differences in the effect on capacity when using one or two tablets at once to stop a migraine attack.
Unwanted side effects when taking Zaldiar
Dizziness was noted by 16% of patients, dry mouth 18%, diarrhea and weakness 12%, abdominal pain 8%, drowsiness 8% of patients. All undesirable side effects occurred when taking more than 2 tablets of Zaldiar, lasted from 1 to 4 hours and passed on their own, without requiring any additional medical correction.
Subjective assessment of the effectiveness of Zaldiar in the treatment of migraine attacks
The subjective assessment by patients of the effectiveness of Zaldiar in the relief of migraine attacks differed significantly from the assessment of previous treatment. Only 8% of patients gave a good assessment of the previous treatment, 60% were satisfactory, and 32% were unsatisfactory.
An analysis of previous therapy showed that 40% of patients used simple analgesics to stop a migraine attack, NSAIDs – 12%, combined drugs – 20%, triptans – 28% (12% sumatriptan at a dose of 50 mg and 16% zolmitriptan at a dose of 2.5 mg). The number of drugs taken ranged from 1 to 7 tablets per day. Patients taking triptans noted no effect (8%) or poor tolerance of drugs (20%) in the form of dizziness, weakness, drowsiness, paresthesia, despite the relief of cephalgic syndrome.
The percentage of positive ratings for the relief of a migraine attack by Zaldiar was significantly higher than that of the previous treatment: a good rating was given by 42% of patients, very good by 16%, satisfactory by 16%, unsatisfactory by 26% of patients. There were no significant differences in the subjective assessment of the effectiveness of patients using one or two Zaldiar tablets at once.
Talk
This study was open-label, not placebo-controlled. A comparative study was conducted on the effectiveness of 1 tablet of Zaldiar and 2 tablets in the relief of a migraine attack. Despite the known limitations in evaluating the study from the point of view of evidence-based medicine, it was possible to demonstrate largely similar data with a double-blind placebo-controlled study performed by S.D. Silderstein et al. (2005) [7]. Thus, the absence of pain after 2 hours of taking 75 mg of tramadol and 650 mg of paracetamol turned out to be comparable: in the American study, 22.1% of seizures, in the Russian one – 24%. The percentage of improvement in the Russian study at a similar dose was better (80%) compared to the US study (55.8%), however, at a lower dose of Zaldiar, the percentage of improvements was identical (56%). In both studies, Zaldiar was effective against associated symptoms: photophobia and phonophobia. The smallest therapeutic effect was obtained in relation to nausea. Similar undesirable side effects have been noted: nausea, dizziness, drowsiness. The frequency of their occurrence and moderate severity were comparable.
Although triptans are first-line drugs for the relief of migraine attacks due to their pathogenetic action, they are contraindicated in a number of patients with uncontrolled arterial hypertension who have had a myocardial infarction or stroke. The positive therapeutic effect of Zaldiar in migraine after 2 hours (56-80%) is fully comparable with the effectiveness of sumatriptan (45-68%), eletriptan (65-78%) [2,3]. Zaldiar, according to our observations, is inferior to triptans only in such an indicator as the return of headache: after 4 hours, more than a third of patients who used Zaldiar note a recurrence of pain, which requires additional analgesic intake. Return when using eletriptan is 23–21% [3,5]. An important issue when using Zaldiar, which has the opioid analgesic tramadol in its composition, is the question of the formation of drug dependence. It should be recalled that any analgesic can be addictive when abused, including simple analgesics, NSAIDs, and triptans. There is evidence in the literature that the formation of drug dependence on tramadod with its systematic use does not exceed dependence on NSAIDs [4].
The frequency of undesirable effects when using 2 or more tablets of Zaldiar exceeds that of triptans, however, undesirable effects are of a different nature (in particular, there are no warning symptoms such as chest pain, a feeling of pressure and compression of the chest).
A comparative study of the effectiveness of various dosages of Zaldiar showed the greatest therapeutic effect of 2 tablets both 2 hours after taking the drug, and in the long-term period after 24 hours. However, the number of observations is obviously insufficient for final conclusions.
Thus, Zaldiar, which has an efficacy significantly higher than simple analgesics and NSAIDs, can be recommended as an alternative analgesic for patients suffering from migraine with severe attacks.
Conclusions
Zaldiar is able to provide the development of rapid and long-term pain relief in patients with migraine attacks of moderate, severe and very severe intensity.
At the same time, concomitant symptoms (photo- and phonophobia) are significantly reduced and the daily activity of patients improves
When taking Zaldiar, a “good and very good” effect of arresting an attack is achieved in 58% of cases, in previous therapy only in 8% of cases.
Zaldiar has an advantageous ratio of efficacy and safety, as it is devoid of a number of undesirable side effects characteristic of NSAIDs, on the one hand, and triptans, on the other. At the same time, Zaldiar is more effective than NSAIDs and approaches the strength of the analgesic effect in migraine to triptans.

Literature
1. Golubev V.L. “Analgesic drug Zaldiar in neurological practice”. Journal of Treatment of Nervous Diseases. 2007, No. 1, pp. 15–20.
2. Efremova I. R., Filatova E.G. “Eletriptan in the relief of migraine attacks” Journal “Treatment of nervous diseases” 2005, No. 2, pp. 36-38.
3. Filatova E.G. “READY is the first Russian multicenter study of the efficacy of Relpax (eletriptan) in the treatment of migraine attacks.” Journal of Treatment of Nervous Diseases. 2006, No. 2, pp. 34–38.
4. Adams E., Breiner S., Ciecro T. et al. A comparison of abuse liability of tramadol, NSAIDs and hydrocodone in patients with chronic pain// J. Pain Symptom Manage.–2006.Vol.31,N5.–P.465–476.
5. Data on file. Pfizer Inc., New York, NY.
6. Edwards J., McQuay H., Moore R. Combination analgesic efficacy: individual patient data meta-analysis of single-dose oral tramadol plus acetaminophen in acute post operative pain.// J. Pain Symptom Manage.–2002.Vol.23.N2. P.–1589–1594.
7. Silberstein S.D., Freitag F., Rozen T., et al., Tramadol/acetaminofen for the treatment of acute migraine pain: findings of randomized, placebo-controlled trial//Headache. –2005.–Vol.45 N10.–P.1317–1327.

TRAMADOL – fast and effective relief from pain

There is hardly a person who is not familiar with the feeling of pain. Even the ancient Greeks said: “Pain is the watchdog of health.” Indeed, it is pain that warns the body of imminent danger.

Today, a large number of painkillers of foreign and domestic production are presented on the pharmaceutical market. Among them is TRAMADOL, the production of which was recently mastered by the Kharkiv OJSC “Pharmaceutical Firm “Health”.

TRAMADOL produced by this enterprise is produced according to domestic technology using an imported substance (tramadol hydrochloride) from Heumann Pharma Gmbh (Austria).

TRAMADOL is a highly effective non-narcotic centrally acting analgesic intended for oral administration in acute or chronic pain of various etiologies. TRAMADOL belongs to the class of moderately toxic drugs and is well tolerated.

As an opiate receptor agonist-antagonist, the drug has a pronounced analgesic activity. Its action occurs 20 minutes after administration and lasts up to 5 hours.

The drug effectively eliminates moderate pain in the postoperative period, with injuries, biliary colic, myocardial infarction, during painful diagnostic procedures. In addition, TRAMADOL has an antitussive effect.

When taken in therapeutic doses, TRAMADOL does not cause respiratory depression and does not affect intestinal motility.

The drug is produced in gelatin capsules of 0.05 g. Adults and children over 14 years old are prescribed 1 capsule with a small amount of liquid.

During treatment with TRAMADOL, some precautions should be observed: refrain from driving a car and performing potentially hazardous activities that require increased attention or speed of mental and motor reactions.