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.

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Publication types

MeSH terms

Substances

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.

Being 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: avoid driving a car and performing potentially hazardous activities that require increased attention or speed of mental and motor reactions.

Patients with impaired liver or kidney function should start treatment with the drug with minimal doses. Special care must be taken when taking TRAMADOL when prescribing it to patients with drug and alcohol addiction.

More than 20 years of clinical experience in the use of tramadol preparations abroad and in Ukrainian clinics testifies to the compliance of the drug with modern requirements for an effective and safe drug to eliminate pain.

It should be noted that TRAMADOL produced by the Pharmaceutical Company Zdorovye is affordable for a wide range of consumers. Its cost is lower than that of foreign analogues.

For more information
and for purchasing
, please contact:
JSC “Pharmaceutical Firm “Health”
61013, Kharkiv, st. Shevchenko, 22
Tel.: (0572) 14-97-16
Fax: (0572) 12-05-88

unique dual mechanism of action implemented in the central nervous system (CNS).

INTRODUCTION

Tramadol is a centrally acting analgesic
with a unique dual mechanism of action implemented in the central nervous
system (CNS). It has an agonistic effect on opiate receptors
and prevents the reuptake of neurotransmitters. Tramadol is also weak
binds to µ-opiate receptors, blocking the transmission of pain signals in
brain. Tramadol effectively controls postoperative pain, however
not suitable for use as an adjuvant to anesthesia in
associated with weak sedative properties.

Pharmacological
class: Opioid
analgesic

Indication

• Moderate or severe pain
• Pain
• Acute musculoskeletal pain

PHARMACOLOGICAL ACTION

Tramadol is a centrally acting opioid analgesic. Although its mechanism of action is not fully understood, based on animal studies, at least two complementary mechanisms are possible: binding of the parent substance and the M1 metabolite to μ-opioid receptors and weak inhibition of norepinephrine and serotonin reuptake. The opioid activity is due to the low affinity of the parent compound and the high affinity of the O-demethylated metabolite M1 for μ-opioid receptors. The relative role of tramadol and M1 in human pain relief is determined by the plasma concentration of each substance. Tramadol inhibits the reuptake of norepinephrine and serotonin in vitro , similar to other opioid analgesics. These mechanisms may play an independent role in the overall analgesic effect of tramadol.

DOSAGE

Adults: 50-100 mg orally every 4-6 hours
needed for pain relief

Children: 1-2.5 mg/kg orally every 8 hours when
necessary for pain relief

PHARMACOKINETICS

Absorption of tramadol is 34%±34. Volume of distribution
is 2.71 l / kg, binding to plasma proteins – 20%. With urine
30% of the drug is excreted (in unchanged form), 60% (in the form of metabolites),
the plasma half-life is 6.3 hours.

CONTRAINDICATIONS

• Hypersensitivity to opioids
• Situations where opioids are contraindicated, including acute
  intoxication with the following substances: alcohol, sleeping pills,
  centrally acting painkillers, opioids or psychotropic
  drugs. In such patients, the drug may exacerbate CNS depression and
  breathing.
• Combination of tramadol and MAO inhibitors (either in
  within 14 days after discontinuation of such therapy) is contraindicated

INTERACTIONS WITH OTHER DRUGS

• Concomitant use of CYP2D6 and/or CYP3A4 inhibitors,
  e.g. quinidine, fluoxetine, paroxetine and amitriptyline (inhibitors
  CYP2D6), ketoconazole and erythromycin (CYP3A4 inhibitors) may reduce
  metabolic clearance of tramadol, increasing the risk of serious
  adverse events, including seizures and serotonin syndrome
• Patients taking carbamazepine may experience
  significantly weaker analgesic effect of tramadol hydrochloride

SIDE EFFECTS

Common (> 1/10, < 1/100):

• Abdominal disorders (diarrhea, constipation,
  nausea or abdominal pain)
• Depression
• Skin disorders (itching, rash or sweating)
• Generalized pain or pain in the muscles and joints

Uncommon (> 1/100, < 1/100 0):

• Joint swelling
• Change in body weight
• Severe headache
• Fall
• Confusion
• Severe cough

Very rare (< 1/10000):

9 0064 Blistering under the skin
• Blood in urine
• Chest pain
• Seizures
• Seizures
• Dark urine
• Fainting
• Numbness of extremities
• Icteric coloration of eyes and skin

PRECAUTIONS

• Pre-existing diseases of the kidneys, liver, epilepsy,
  history of lung disease, drug dependence or allergy
• Pregnancy and breastfeeding
• Use of drugs such as
  tranquilizers, sleeping pills or other pain medications containing
  opiates
• Acute diseases of the abdominal organs
  cavities subject to clinical evaluation

Clinical data

• Tramadol is a centrally acting analgesic,
  which is similar in structure to codeine and morphine. Its effect in
  relief of the postoperative share is comparable to that
  pethidine. The analgesic effect of tramadol is increased in combination with
  non-opioid analgesics. Tramadol is effective and well tolerated
  patients when used to relieve pain after trauma, renal or
  hepatic colic or during childbirth. The drug is also used to treat
  chronic pain of malignant or non-malignant origin, in
  features in neuropathic pain. Tramadol is less likely to cause constipation and
  dependence compared to powerful opioids in similar analgesics
  doses.
• The effectiveness of tramadol in the treatment
  moderate or severe postoperative pain has been shown in outpatient and
  surgical conditions. Unlike other opioids, tramadol does not
  has clinically significant effects on respiratory and cardiovascular
  indicators. This drug may be particularly suitable for patients with
  impaired cardiopulmonary function, including elderly patients, patients with
  obese and smokers, for patients with impaired liver or kidney function, and
  also for patients who are receiving non-steroidal anti-inflammatory drugs
  (NSAIDs) are not recommended or should be used with caution. Tramadol
  for parenteral or oral administration has proven to be effective and
  tolerance for anesthesia during operations.
• Tramadol is effective for the treatment
  various types of moderate to severe acute and chronic pain, including neuropathic
  pain, back pain, osteoarthritis and uncontrolled pain. The
  the drug also causes fewer side effects that are characteristic of opioids,
  including nausea, drowsiness, vomiting, dry mouth and constipation. Although the study
  literature data showed the presence of an immunostimulating effect
  tramadol, some studies also suggest that
  that the immunosuppressive effect of tramadol is less pronounced compared with
  morphine. Due to pharmacological properties, tramadol is more
  more suitable for patients with gastrointestinal and renal disorders than NSAIDs. Apart from
  proven clinical efficacy, tramadol is a safe drug,
  because it causes respiratory depression to a lesser extent, cardiovascular
  side effects, abuse and dependence compared to others
  opioids.