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Exalgo

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Exalgo

Exalgo

Exalgo Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Exalgo (hydromorphone HCl) Extended Release Tablets is used to help relieve moderate to severe ongoing pain (such as due to cancer). It is a narcotic (opiate) analgesic. Common side effects include nausea, vomiting, constipation, lightheadedness, dizziness, or drowsiness.

The dose of Exalgo is taken once daily, with food. Patients will be monitored when starting this drug. Exalgo may interact with medications for pain, narcotic antagonists, other products that may also affect breathing or cause drowsiness such as alcohol, allergy or cough-and-cold products, anti-seizure drugs, medicines for sleep or anxiety, muscle relaxants, narcotics, or psychiatric medicines. Tell your doctor all medications and supplements you use. During pregnancy, Exalgo should be used inly if prescribed. Tell your doctor if you are pregnant or if you plan to become pregnant. Thus drug may increase the risk of birth defects if used during the first two months of pregnancy. Using it near the expected delivery date may harm the fetus. Tell the doctor right away if you notice symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea. This drug passes into breast milk and may have undesirable effects on a nursing infant. Tell the doctor if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking this medication.

Our Exalgo (hydromorphone HCl) Extended Release Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Exalgo in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heartbeat;
  • seizure (convulsions);
  • cold, clammy skin;
  • confusion;
  • severe weakness or dizziness; or
  • feeling light-headed, fainting.

Less serious side effects are more likely to occur, such as:

  • nausea, vomiting, constipation, loss of appetite;
  • warmth, tingling, or redness under your skin;
  • dizziness, headache;
  • dry mouth;
  • sweating; or
  • itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Exalgo (Hydromorphone Hydrochloride Extended Release Tablets) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Exalgo Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, or drowsiness may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

You may notice an empty tablet shell in your stool. This is harmless because your body has already absorbed the medicine.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, hallucinations, confusion), severe stomach/abdominal pain, difficulty urinating.

Seek immediate medical attention if any of these rare but serious side effects occur: fainting, slow/shallow breathing, unusual drowsiness/difficulty waking up, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Exalgo (Hydromorphone Hydrochloride Extended Release Tablets)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Exalgo FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

EXALGO was administered to a total of 2,524 patients in 15 controlled and uncontrolled clinical studies. Of these, 423 patients were exposed to EXALGO for greater than 6 months and 141 exposed for greater than one year.

The most common adverse reactions leading to study discontinuation were nausea, vomiting, constipation, somnolence, and dizziness. The most common treatment-related serious adverse reactions from controlled and uncontrolled chronic pain studies were drug withdrawal syndrome, overdose, confusional state, and constipation.

The overall incidence of adverse reactions in patients greater than 65 years of age was higher, with a greater than 5% difference in rates for constipation and nausea when compared with younger patients. The overall incidence of adverse reactions in female patients was higher, with a greater than 5% difference in rates for nausea, vomiting, constipation and somnolence when compared with male patients.

A 12-week double-blind, placebo-controlled, randomized withdrawal study was conducted in opioid tolerant patients with moderate to severe low back pain [see Clinical Studies]. A total of 447 patients were enrolled into the open-label titration phase with 268 patients randomized into the double-blind treatment phase. The adverse reactions that were reported in at least 2% of the patients are contained in Table 2.

Table 2: Number (%) of Patients with Adverse Reactions Reported in ≥ 2% of Patients with Moderate to Severe Low Back Pain During the Open-Label Titration Phase or Double-Blind Treatment Phase by Preferred Term

Preferred Term Open-Label Titration Phase EXALGO
(N=447)
Double-Blind Treatment Phase
EXALGO
(N=134)
Placebo
(N=134)
Constipation 69 (15) 10 (7) 5 (4)
Nausea 53 (12) 12 (9) 10 (7)
Somnolence 39 (9) 1 (1) 0 (0)
Headache 35 (8) 7 (5) 10 (7)
Vomiting 29 (6) 8 (6) 6 (4)
Drug Withdrawal Syndrome 22 (5) 13 (10) 16 (12)
Pruritus 21 (5) 1 (1) 0 (0)
Dizziness 17 (4) 3 (2) 2 (1)
Asthenia/Fatigue 16 (4) 2 (1) 6 (4)
Insomnia 13 (3) 7 (5) 5 (4)
Diarrhea 13 (3) 5 (4) 9 (7)
Back Pain 13 (3) 6 (4) 8 (6)
Dry Mouth 13 (3) 2 (1) 0 (0)
Edema Peripheral 13 (3) 3 (2) 1 (1)
Hyperhidrosis 13 (3) 2 (1) 2 (1)
Anorexia/Decreased Appetite 10 (2) 2 (1) 0 (0)
Arthralgia 9 (2) 8 (6) 3 (2)
Anxiety 9 (2) 0 (0) 4 (3)
Abdominal Pain 9 (2) 4 (3) 3 (2)
Muscle Spasms 5 (1) 3 (2) 1 (1)
Weight Decreased 3 (1) 4 (3) 3 (2)

The adverse reactions that were reported in at least 2% of the total treated patients (N=2,474) in the 14 chronic clinical trials are contained in Table 3.

Table 3: Number (%) of Patients with Adverse Reactions Reported in ≥ 2% of Patients with Chronic Pain Receiving EXALGO in 14 Clinical Studies by Preferred Term

Preferred Term All Patients (N=2,474)
Constipation 765 (31)
Nausea 684 (28)
Vomiting 337 (14)
Somnolence 367 (15)
Headache 308 (12)
Asthenia/Fatigue 272 (11)
Dizziness 262 (11)
Diarrhea 201 (8)
Pruritus 193 (8)
Insomnia 161 (7)
Hyperhidrosis 143 (6)
Edema Peripheral 135 (5)
Anorexia/Decreased Appetite 139 (6)
Dry Mouth 121 (5)
Abdominal Pain 115 (5)
Anxiety 95 (4)
Back Pain 95 (4)
Dyspepsia* 88 (4)
Depression 81 (3)
Dyspnea 76 (3)
Muscle Spasms 74 (3)
Arthralgia 72 (3)
Rash 64 (3)
Pain in Extremity 63 (3)
Pain 58 (2)
Drug Withdrawal Syndrome 55 (2)
Pyrexia 52 (2)
Fall 51 (2)
Chest pain 51 (2)
* Reflux esophagitis, gastroesophageal reflux disease and Barrett's esophagus were grouped and reported with dyspepsia

The following Adverse Reactions occurred in patients with an overall frequency of < 2% and are listed in descending order within each System Organ Class:

Cardiac disorders: palpitations, tachycardia, bradycardia, extrasystoles

Ear and labyrinth disorders: vertigo, tinnitus

Endocrine disorders: hypogonadism

Eye disorders: vision blurred, diplopia, dry eye, miosis

Gastrointestinal disorders: flatulence, dysphagia, hematochezia, abdominal distension, hemorrhoids, abnormal feces, intestinal obstruction, eructation, diverticulum, gastrointestinal motility disorder, large intestine perforation, anal fissure, bezoar, duodenitis, ileus, impaired gastric emptying, painful defecation

General disorders and administration site conditions: chills, malaise, feeling abnormal, feeling hot and cold, feeling jittery, hangover, difficulty in walking, feeling drunk, hypothermia

Infections and infestations: gastroenteritis, diverticulitis

Injury, poisoning and procedural complications: contusion, overdose

Investigations: weight decreased, hepatic enzyme increased, blood potassium decreased, blood amylase increased, blood testosterone decreased, oxygen saturation decreased

Metabolism and nutrition disorders: dehydration, fluid retention, increased appetite, hyperuricemia

Musculoskeletal and connective tissue disorders: myalgia

Nervous system disorders: tremor, sedation, hypoesthesia, paresthesia, disturbance in attention, memory impairment, dysarthria, syncope, balance disorder, dysgeusia, depressed level of consciousness, coordination abnormal, hyperesthesia, myoclonus, dyskinesia, hyperreflexia, encephalopathy, cognitive disorder, convulsion, psychomotor hyperactivity

Psychiatric disorders: confusional state, nervousness, restlessness, abnormal dreams, mood altered, hallucination, panic attack, euphoric mood, paranoia, dysphoria, listless, crying, suicide ideation, libido decreased, aggression

Renal and urinary disorders: dysuria, urinary retention, urinary frequency, urinary hesitation, micturition disorder

Reproductive system and breast disorders: erectile dysfunction, sexual dysfunction

Respiratory, thoracic and mediastinal disorders: rhinorrhea, respiratory distress, hypoxia, bronchospasm, sneezing, hyperventilation, respiratory depression

Skin and subcutaneous tissue disorders: erythema

Vascular disorders: flushing, hypertension, hypotension

Postmarketing Experience

The following adverse reaction has been identified during post-approval use of EXALGO:

Skin and subcutaneous tissue disorders: urticaria

Read the entire FDA prescribing information for Exalgo (Hydromorphone Hydrochloride Extended Release Tablets) »

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Exalgo - User Reviews

Exalgo User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Exalgo sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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