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Palladone (Hydromorphone Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The safety of Palladone™ Capsules was evaluated in double-blind clinical trials involving 612 patients with moderate to severe pain. An open-label extension study involving 143 patients with cancer pain was conducted to evaluate the safety of Palladone™ Capsules when used for longer periods of time in higher doses than in the controlled trials. Patients were treated with doses averaging 40 to 50 mg of Palladone™ Capsules per day (ranging between 12 and 500 mg/day) for several months (range 1 to ≥52 weeks).

Serious adverse reactions which may be associated with Palladone™ Capsules therapy in clinical use are similar to those of other opioid analgesics, including respiratory depression, apnea, respiratory arrest, and to a lesser degree, circulatory depression, hypotension, shock or cardiac arrest (see OVERDOSAGE).

Adverse Events Reported in Controlled Trials

Table 3 lists treatment emergent signs and symptoms that were reported in at least 2% of patients in the placebo-controlled trials for which the rate of occurrence was greater for those treated with 12mg Palladone™ Capsules than those treated with placebo.drug abuse and dependence (addiction)

TABLE 3. Adverse Events Reported in the Placebo-Controlled Clinical Trials With Incidence ≥ 2% in Patients Receiving Palladone™ Capsules for Nonmalignant Pain
Placebo*
(N = 191)
Palladone™*
(N = 190)
Body System/
COSTART Term
Double-blind
%
Double-blind
%
* Average exposure was 21 days for Palladoneä and 15 days for placebo.
Total percentage of patients
with AEs
35.1%49.5%
Body as a Whole15.7%18.4%
    Headache
    Asthenia
    Infection
2.1%
0.5%
5.8%
4.7%
3.2%
5.3%
 
Digestive13.1%27.9%
    Constipation
    Nausea
    Vomiting
1.0%
6.3%
1.6%
15.8%
10.5%
3.2%
 
Nervous13.1%11.6%
    Somnolence 1.6%4.7%
 
Skin 5.2%4.7%
    Pruritus 1.0%2.6%

Adverse Events Observed in Clinical Trials

Palladone™ Capsules have been administered to 785 individuals during completed clinical trials. The conditions and duration of exposure to Palladone™ varied greatly, and included open-label and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, fixed dose and titration studies. Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing.

These categories are used in the listing below. The frequencies represent the proportion of 785 patients from these trials who experienced that event while receiving Palladone™ Capsules. All adverse events included in this tabulation occurred in at least one patient. Events are classified by body system and listed using the following definitions: frequent adverse events - those occurring in at least 1/100 patients; adverse events occurring with an incidence less than 1% are considered infrequent. These adverse events are not necessarily related to Palladone™ Capsule treatment and in most cases were observed at a similar frequency in placebo-treated patients in the controlled studies.

Frequent Adverse Events

Body as a Whole: headache, asthenia, pain, abdominal pain, fever, chest pain, infection, chills, malaise, neck pain, carcinoma, accidental injury

Cardiovascular: vasodilatation, tachycardia, migraine

Digestive: nausea, constipation, vomiting, diarrhea, dyspepsia, anorexia, dry mouth, nausea and vomiting, dysphagia, flatulence

Hematologic and Lymphatic: anemia, leukopenia

Metabolic and Nutritional: peripheral edema, dehydration, edema, generalized edema, hypokalemia, weight loss

Musculoskeletal: arthralgia, bone pain, leg cramps, myalgia

Nervous: somnolence, dizziness, nervousness, confusion, insomnia, anxiety, depression, hypertonia, hypesthesia, paresthesia, tremor, thinking abnormal, hallucinations, speech disorder, agitation, amnesia, tinnitus, abnormal gait

Respiratory: dyspnea, cough increased, rhinitis, pharyngitis, pneumonia, epistaxis, hiccup, hypoxia, pleural effusion

Skin and Appendages: pruritus, sweating, rash

Special Senses: amblyopia, taste perversion

Urogenital: dysuria, urinary incontinence Infrequent Adverse Events

Infrequent Adverse Events

Body as a Whole: face edema, ascites, allergic reaction, cellulitis, overdose, hypothermia, neoplasm, photosensitivity reaction, sepsis, flank pain

Cardiovascular: hypertension, hypotension, syncope, deep thrombophlebitis, arrhythmia, postural hypotension, atrial fibrillation, pallor, bradycardia, electrocardiogram abnormal, myocardial infarction, palpitation, angina pectoris, congestive heart failure, QT interval prolonged, supraventricular tachycardia, thrombosis, cardiomegaly, hemorrhage

Digestive: fecal impaction, intestinal obstruction, abnormal stools, fecal incontinence, hepatic failure, increased appetite, cholangitis, cholecystitis, colitis, enterocolitis, hepatomegaly, jaundice, liver function tests abnormal, biliary spasm, ileus, eructation, rectal hemorrhage, esophagitis, glossitis, melena, mouth ulceration, gastrointestinal hemorrhage, tongue edema

Endocrine: adrenal cortex insufficiency

Hematologic and Lymphatic: ecchymosis, thrombocytopenia, leukocytosis, lymphadenopathy, agranulocytosis, lymphoma like reaction, pancytopenia, petechia

Metabolic and Nutritional: hyperglycemia, hyponatremia, cachexia, hypercalcemia, hypomagnesemia, cyanosis, diabetes mellitus, gout, respiratory acidosis, elevated liver enzymes, thirst

Musculoskeletal: myasthenia

Nervous: abnormal dreams, emotional lability, paranoid reaction, sleep disorder euphoria, incoordination, stupor, ataxia, convulsion, hallucination, hostility, myoclonus, psychosis, vertigo, withdrawal syndrome, apathy, delirium, dementia, drug dependence, nystagmus, twitching, depersonalization, aphasia, cerebrovascular accident, circumoral parasthesia, seizure, hyperkinesia, hypotonia, increased salivation, neuralgia

Respiratory: hypoventilation, apnea, atelectasis, hemoptysis, asthma, hyperventilation, pulmonary embolus, laryngismus

Skin and Appendages: urticaria, maculopapular rash, alopecia

Special Senses: abnormal vision, diplopia, dry eyes, lacrimation disorder, hyperacusis

Urogenital: urinary retention, hematuria, impotence, urinary frequency, urination impaired, dysmenorrhea, creatinine increased, urinary urgency

Additional Adverse Events From Non-U.S. Experience

Addiction, blurred vision, drowsiness, dysphoria, sedation, seizure, physical dependence, biliary spasm, and ileus



REPORTS OF SUSPECTED PALLADONE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Palladone. The information is not vetted and should not be considered as verified clinical evidence.

Possible Palladone side effects / adverse reactions in 40 year old male

Reported by a physician from Germany on 2011-12-21

Patient: 40 year old male

Reactions: Arthralgia, Convulsion

Suspect drug(s):
Analgesics
    Indication: Product Used FOR Unknown Indication

Palladone
    Indication: Product Used FOR Unknown Indication

Hydromorphone HCL
    Indication: Product Used FOR Unknown Indication



Possible Palladone side effects / adverse reactions in 81 year old male

Reported by a physician from Germany on 2012-02-21

Patient: 81 year old male weighing 68.0 kg (149.6 pounds)

Reactions: Prostate Cancer, Hepatotoxicity, Dehydration, Toxicity TO Various Agents

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Palladone
    Administration route: Oral
    Indication: Pain
    Start date: 2009-11-25
    End date: 2009-12-29

Haldol
    Administration route: Oral
    Indication: Nausea
    Start date: 2009-11-25
    End date: 2009-12-29

Hydromorphone HCL
    Administration route: Oral
    Indication: Pain
    Start date: 2009-12-13
    End date: 2009-12-29

Duragesic-100
    Indication: Pain
    Start date: 2009-12-29

Other drugs received by patient: Metamizole; Sunitinib Malate; Scopolamine; Moviprep; Omeprazole; Kevatril; Lyrica; Paroxetine; Metoclopramide; Zoladex; Furosemide; Lorazepam; Zometa; Prednisone



Possible Palladone side effects / adverse reactions in 81 year old male

Reported by a consumer/non-health professional from United States on 2012-02-24

Patient: 81 year old male weighing 68.0 kg (149.6 pounds)

Reactions: Prostate Cancer, Hepatotoxicity, Dehydration, Toxicity TO Various Agents

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Haldol
    Dosage: unk
    Administration route: Oral
    Indication: Nausea
    Start date: 2009-11-25
    End date: 2009-12-29

Palladone
    Dosage: 26 ug, qid
    Administration route: Oral
    Indication: Pain
    Start date: 2009-11-25
    End date: 2009-12-29

Exalgo
    Dosage: 32 mg, qd
    Administration route: Oral
    Indication: Pain
    Start date: 2009-12-13
    End date: 2009-12-29

Duragesic-100
    Dosage: unk
    Indication: Pain
    Start date: 2009-12-29

Other drugs received by patient: Furosemid /00032601/; Lyrica; Paroxetine; Kevatril; Zoladex; Metamizole; Omeprazole; Zometa; Lorazepam; Prednisone TAB; Movicol /01625101/; MCP /00041901/; Sunitinib Malate; Scopoderm /00008701/



See index of all Palladone side effect reports >>

Drug label data at the top of this Page last updated: 2006-01-04

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