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In addition to requiring new labeling on these prescript"...
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;
- 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
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
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
The following serious adverse reactions are discussed elsewhere in the labeling:
- Respiratory Depression [see WARNINGS AND PRECAUTIONS]
- Chronic Pulmonary Disease [see WARNINGS AND PRECAUTIONS]
- Head Injuries and Increased Intracranial Pressure [see WARNINGS AND PRECAUTIONS]
- Interactions with Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
- Hypotensive Effect [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Effects [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
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
|Preferred Term||Open-Label Titration Phase EXALGO
|Double-Blind Treatment Phase|
|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)|
|Edema Peripheral||135 (5)|
|Anorexia/Decreased Appetite||139 (6)|
|Dry Mouth||121 (5)|
|Abdominal Pain||115 (5)|
|Back Pain||95 (4)|
|Muscle Spasms||74 (3)|
|Pain in Extremity||63 (3)|
|Drug Withdrawal Syndrome||55 (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:
Endocrine disorders: hypogonadism
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
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
Reproductive system and breast disorders: erectile dysfunction, sexual dysfunction
Skin and subcutaneous tissue disorders: erythema
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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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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