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Last reviewed on RxList: 6/16/2017
Exalgo Side Effects Center

Last reviewed on RxList 06/16/2017

Exalgo (hydromorphone HCl) Extended Release Tablets is a narcotic pain reliever (opiate analgesic) used to help relieve moderate to severe ongoing pain (such as due to cancer). Common side effects of Exalgo include:

Tell your doctor if you have serious side effects of Exalgo including:

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 only 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.

Exalgo Consumer Information

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 a serious side effect such as:

  • weak or shallow breathing;
  • pounding heartbeats or fluttering in your chest;
  • wheezing, chest tightness, trouble breathing;
  • seizure (convulsions);
  • confusion, severe weakness or drowsiness; or
  • feeling like you might pass out.

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

  • blurred vision, double vision;
  • flushing (warmth, redness, or tingly feeling);
  • nausea, vomiting, constipation, diarrhea, stomach pain;
  • dizziness, drowsiness;
  • dry mouth;
  • sweating;
  • itching; or
  • sleep problems (insomnia), or strange dreams.

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.

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

Exalgo Professional Information


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

Clinical Trial 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
Double-Blind Treatment Phase
EXALGO (N=447) 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)
Pruritus 21 (5) 1 (1) 0 (0)
Dizziness 17 (4) 3 (2) 2 (1)
Insomnia 13 (3) 7 (5) 5 (4)
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)
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 of body temperature change, feeling jittery, hangover, gait disturbance, feeling drunk, body temperature decreased

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

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, crying, 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, 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 reactions have been identified during post approval use of hydromorphone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs [see DRUG INTERACTIONS].

Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use [see WARNINGS AND PRECAUTIONS].

Anaphylaxis: Anaphylactic reaction has been reported with ingredients contained in EXALGO [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].

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

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© Exalgo Patient Information is supplied by Cerner Multum, Inc. and Exalgo Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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