FUN Facts regarding Tramadol

FUN Facts regarding medication Tramadol

For the Consumer

Applies to tramadol: oral capsule extended release, oral suspension, oral tablet, oral tablet disintegrating, oral tablet extended release

Tramadol (marketed as Ultram, and as generics) is an opiod pain medication which is used to treat moderate to moderately severe pain. When taken as an immediate-release oral formulation, the onset of pain relief usually occurs within about an hour. It has two different mechanisms. First, it binds to the μ-opioid receptor. Second, it inhibits the reuptake of serotonin and norepinephrine. (a hormone that is released by the adrenal medulla and by the sympathetic nerves and functions as a neurotransmitter. It is also used as a drug to raise blood pressure.)

As well as its needed effects, tramadol may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking tramadol, check with your doctor immediately:

You may experience some of these side effects if you discontinue use of  Tramadol.

More common

Abdominal or stomach pain

agitation

anxiety

constipation

cough

diarrhea

discouragement

drowsiness

dry mouth

feeling of warmth

feeling sad or empty

feeling unusually cold

fever

general feeling of discomfort or illness

headache

heartburn

irritability

itching of the skin

joint pain

loss of appetite

loss of interest or pleasure

loss of strength or weakness

muscle aches and pains

nausea

nervousness

redness of the face, neck, arms, and occasionally, upper chest

restlessness

runny nose

shivering

skin rash

sleepiness or unusual drowsiness

sore throat

stuffy nose

sweating

tiredness

trouble concentrating

unusual feeling of excitement

weakness

Abnormal dreams

appetite decreased

back pain

bladder pain

blistering, crusting, irritation, itching, or reddening of the skin

bloody or cloudy urine

body aches or pain

change in hearing

clamminess

cold flu-like symptoms

confusion

cough producing mucus

cracked, dry, or scaly skin

decreased interest in sexual intercourse

difficult, burning, or painful urination

difficulty with moving

disturbance in attention

ear congestion

ear drainage

earache or pain in ear

excessive gas

fall

false or unusual sense of well-being

feeling hot

feeling jittery

flushing or redness of the skin

general feeling of bodily discomfort

goosebumps

headache, severe and throbbing

hoarseness

hot flashes

inability to have or keep an erection

itching, pain, redness, swelling, tenderness, or warmth on the skin

joint sprain

joint stiffness

joint swelling

loss in sexual ability, desire, drive, or performance

loss of voice

lower back or side pain

muscle aching or cramping

muscle injury

muscle pain or stiffness

muscle spasms or twitching

nasal congestion

neck pain

night sweats

pain

pain in the limbs

pain or tenderness around the eyes and cheekbones

pain, swelling, or redness in the joints

skin discoloration

swelling

swelling of the hands, ankles, feet, or lower legs

tightness of the chest

trouble in holding or releasing urine

trouble with sleeping

troubled breathing

weight increased or decreased

Tramadol - You Need to Know (READ THIS)

Generic Name: tramadol (TRAM a dol)

Brand Names: ConZip, Rybix ODT, Ryzolt, Ultram

Tramadol is a centrally-acting, oral narcotic analgesic and is approved for the treatment of moderate to moderately severe pain in adults. The extended-release form of tramadol is for around-the-clock treatment of pain and not for use on an as-needed basis for pain. A combination product of tramadol and acetaminophen (Ultracet) is also available by prescription. In 2013, over 43 million tramadol prescriptions were written in the U.S, according to IMS.

In 1995, tramadol was originally approved by the U.S. Food and Drug Administration (FDA) as a non-controlled analgesic. However, since 1995, changes to the controlled substance status of tramadol have been made due to reports of drug abuse and diversion. The Drug Abuse Warning Network (DAWN) reported that roughly 20,000 emergency department visits were related to tramadol non-medical use in 2011. According to the National Survey on Drug Use and Health (NSDUH) in 2012, 3.2 million people in the U.S. aged 12 or used tramadol for nonmedical purposes.

1. ****Tramadol is now a controlled substance in all 50 U.S. states.****

On July 7, 2014 the U.S. Drug Enforcement Administration (DEA) announced that tramadol has been placed into schedule IV of the Controlled Substances Act (CSA) effective August 18, 2014. The new scheduling applies to all forms of tramadol. The rescheduling of tramadol comes at a time of growing concern related to abuse, misuse, addiction and overdose of opioid analgesics. Previously tramadol was a controlled substance in only a few states.

Starting August 18, 2014 tramadol prescriptions may only be refilled up to five times within a six month period after the date on which the prescription was written. After five refills or after six months, whichever occurs first, a new prescription is required. This rule applies to all controlled substances in schedule III and IV.

2. Tramadol is associated with a wide array of side effects.

In many people, tramadol is well-tolerated when used for pain, but tramadol can also cause some common and serious side effects. It is important to review with your doctor the side effects that have been reported with tramadol before starting treament Side effects with tramadol may worsen with higher doses.

Common side effects may include:

itching

headache

diarrhea

nausea

vomiting

constipation

dizziness

drowsiness

impaired mental abilities

Serious (but less common or even rare) side effects may include:

seizures

serotonin syndrome

depressed breathing

life-threatening allergic reactions

angioedema, or swelling under the skin

possibly fatal skin reactions

orthostatic hypotension (low blood pressure that occurs when you stand up from sitting or lying down)

suicide thoughts or action

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Withdrawal symptoms may occur if tramadol hydrochloride is discontinued abruptly (DRUG ABUSE AND DEPENDENCE). Reported symptoms have included anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations. Other symptoms that have been reported less frequently with tramadol hydrochloride discontinuation include panic attacks, severe anxiety, and paresthesias. Clinical experience suggests that withdrawal symptoms may be avoided by tapering tramadol hydrochloride at the time of discontinuation.

**FYI When you do Wean off of this medication. Just know you will be withdrawing from two different medications. One Opiod and the Other SSRI =(Double trouble)

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Seizures have occurred in patients taking recommended doses but are more likely at high doses associated with abuse of tramadol.

*Do not abruptly stop taking tramadol as withdrawal symptoms like nausea, diarrhea, anxiety, or tremors may occur. Consult with your doctor for a tapering dose schedule if you are stopping tramadol treatment.

3. Dangerous drug interactions are possible with tramadol.

Tramadol may cause a dangerous condition known as “serotonin syndrome”. Patients receiving serotonergic drugs such as the migraine agents called “triptans” may be at a higher risk for serotonin syndrome. Brand names of triptans include Imitrex, Zomig, Frova, Maxalt, Axert, Amerge, and Relpax.

Do not take tramadol if you have used alcohol, sedatives, tranquilizers, or narcotic medications. Tramadol should not be combined with these medications or with alcohol at any time. Patients should avoid driving or other activities that require mental alertness until the effects of the drug are known.

Patients should always have a drug interaction review completed each time they start a new medication, including herbal, over-the-counter, and supplement drugs.

4. Tramadol can be habit-forming.

Tramadol is structurally related to the opioids like codeine and morphine and can lead to psychological and physical dependence, addiction, and withdrawal. People with a history of a drug-seeking behavior may be at greater risk of addiction, but illicit actions to obtain the drug can occur in people without a prior addiction, as well.

Do not abruptly stop taking tramadol as withdrawal symptoms like nausea, diarrhea, anxiety, sweating, difficulty in sleep, shivering, pain, tremors, or rarely, hallucinations may occur.

Consult with your doctor before discontinuing tramadol treatment; do NOT discontinue treatment on your own. Withdrawal symptoms may be relieved by re-initiation of opioid therapy followed by a slow, dose reduction combined with symptomatic support, as directed by your doctor.

General

The most common adverse reactions include nausea, constipation, dry mouth, somnolence, dizziness, and vomiting.

Psychiatric

CNS stimulation has been reported as a composite of nervousness, anxiety, agitation, tremor, spasticity, euphoria, emotional lability, and hallucinations. During clinical trials, tolerance development was mild and the reports of a withdrawal syndrome were rare. Symptoms of a withdrawal syndrome have included: panic attacks, severe anxiety, hallucinations, paraesthesias, tinnitus and unusual CNS symptoms (i.e. confusion, delusions, personalization, derealization, and paranoia).

Very common (10% or more): CNS stimulation (up to 14%)

Common (1% to 10%): Anxiety, euphoria, nervousness, sleep disorder, insomnia, depression, agitation, apathy, depersonalization

Uncommon (0.1% to 1%): Emotional lability

Rare (less than 0.1%): Hallucinations, nightmares, dependency

Very rare (less than 0.01%): Withdrawal syndrome

Hypersensitivity

Rare (less than 0.1%): Anaphylaxis, allergic reactions such as dyspnea, bronchospasm, wheezing, angioneurotic edema, swollen skin]

Gastrointestinal

Very common (10% or more): Nausea (up to 40%), constipation (up to 46%), vomiting (up to 17%), dyspepsia (up to 13%)

Common (1% to 10%): Dry mouth, diarrhea, abdominal pain, flatulence, sore throat, gastroenteritis viral

Uncommon (0.1% to 1%): Toothache, appendicitis, pancreatitis

Nervous system

Very common (10% or more): Dizziness (up to 28%), somnolence (up to 25%), headache (up to 32%),

Common (1% to 10%): Confusion, coordination disturbance, tremor, paresthesia, hypoesthesia

Uncommon (0.1% to 1%): Migraine, sedation, syncope, disturbance in attention

Rare (less than 0.1%): Epileptiform seizures

Postmarketing reports: Seizures

Epileptiform seizures primarily occurred following administration of high doses or following concomitant treatment with drugs that lower the seizure threshold or trigger seizures.

Dermatologic

Very common (10% or more): Pruritus (up to 11%)

Common (1% to 10%): Sweating, rash, dermatitis

Uncommon (0.1% to 1%): Cellulitis, piloerection, clamminess, urticaria, toxic epidermal necrolysis, Stevens Johnson-syndrome, hair disorder, skin disorder

Genitourinary

Common (1% to 10%): Menopausal symptoms, urinary frequency, urinary retention, urinary tract infection

Uncommon (0.1% to 1%): Difficulty in micturition, hematuria, dysuria, cystitis, sexual function abnormality

Cardiovascular

Very common (10% or more): Flushing (up to 15.8%)

Common (1% to 10%): Vasodilation, postural hypotension, chest pain

Uncommon (0.1% to 1%): Palpitations, myocardial infarction, lower limb edema, peripheral swelling, hypertension, increased heart rate, peripheral ischemia, EKG abnormality, hypotension, tachycardia

Rare (less than 0.1%): Bradycardia

Other

Very common (10% or more): Asthenia (up to 12%)

Common (1% to 10%): Malaise, weakness, pain, feeling hot, influenza like illness, rigors, lethargy, pyrexia

Uncommon (0.1% to 1%): Tinnitus, vertigo, ear infection

Metabolic

Common (1% to 10%): Anorexia, decreased weight, increased blood glucose

Uncommon (0.1% to 1%): Gout

Rare (less than 0.1%): Changes in appetite

Endocrine

Very rare (less than 0.01%): Syndrome of inappropriate antidiuretic hormone secretion

Hematologic

Uncommon (0.1% to 1%): Anemia, ecchymosis

Hepatic

Uncommon (0.1% to 1%): Cholelithiasis, cholecystitis, ALT and AST increased, abnormal liver function tests

Ocular

Common (1% to 10%): Miosis, visual disturbance, blurred vision

Uncommon (0.1% to 1%): Lacrimation disorder

Frequency not reported: Mydriasis

Renal

Uncommon (0.1% to 1%): blood urea nitrogen increased

Musculoskeletal

Common (1% to 10%): Hypertonia, arthralgia, back pain, limb pain, neck pain, muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, aggravated osteoarthritis

Uncommon (0.1% to 1%): Joint swelling, joint sprain, muscle injury, leg cramps

Rare (less than 0.1%): Involuntary muscle contractions

If you don't know. Now you know. I learned the hard way.

I am happy to say I no longer "need to" ingest this what I affectionately name "evil drug" anymore. I use other ways to manage my discomfort. Ice, stretching, Tens Unit (TENS, or transcutaneous electrical nerve stimulation, is a back pain treatment that uses low voltage electric current to relieve pain) Heat, massage to name a few.

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