Fendermal Adverse Reactions

The safety of fentanyl patch was evaluated in 1,565 adult and 289 paediatric subjects who participated in 11 clinical studies (1 double-blind, placebo-controlled; 7 open-label, active-controlled; 3 open-label, uncontrolled) used for the management of chronic malignant or non-malignant pain. These subjects received at least one dose of fentanyl patch and provided safety data. Based on pooled safety data from these clinical studies, the most commonly reported (i.e. ≥10% incidence) adverse reactions were: nausea (35.7%), vomiting (23.2%), constipation (23.1%), somnolence (15.0%), dizziness (13.1%), and headache (11.8%).
The adverse reactions reported with the use of fentanyl patch from these clinical studies, including the previously-mentioned adverse reactions, and from post-marketing experiences are listed as follows.
The displayed frequency categories use the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available clinical data). The adverse reactions are presented by System Organ Class and in order of decreasing seriousness within each frequency category.
Immune system disorders: Common: Hypersensitivity.
Not known: Anaphylactic shock, anaphylactic reaction, anaphylactoid reaction.
Metabolism and nutrition disorders: Common: Anorexia.
Psychiatric disorders: Common: Insomnia, depression, anxiety, confusional state, hallucination.
Uncommon: Agitation, disorientation, euphoric mood.
Not known: Delirium.
Nervous system disorders: Very common: Somnolence, dizziness, headache.
Common: Tremor, paraesthesia.
Uncommon: Hypoaesthesia, convulsion (including clonic convulsions and grand mal convulsion), amnesia, depressed level of consciousness, loss of consciousness.
Eye disorders: Uncommon: Blurred vision.
Rare: Miosis.
Ear and labyrinth disorders: Common: Vertigo.
Cardiac disorders: Common: Palpitations, tachycardia.
Uncommon: Bradycardia, cyanosis.
Vascular disorders: Common: Hypertension.
Uncommon: Hypotension.
Respiratory, thoracic and mediastinal disorders: Common: Dyspnoea.
Uncommon: Respiratory depression, respiratory distress.
Rare: Apnoea, hypoventilation.
Not known: Bradypnoea.
Gastrointestinal disorders: Very common: Nausea, vomiting, constipation.
Common: Diarrhoea, dry mouth, abdominal pain, abdominal pain upper, dyspepsia.
Uncommon: Ileus.
Rare: Subileus.
Skin and subcutaneous tissue disorders: Common: Hyperhidrosis, pruritus, rash, erythema.
Uncommon: Eczema, dermatitis allergic, skin disorder, dermatitis, dermatitis contact.
Musculoskeletal and connective tissue disorders: Common: Muscle spasms.
Uncommon: Muscle twitching.
Renal and urinary disorders: Common: Urinary retention.
Reproductive system and breast disorders: Uncommon: Erectile dysfunction, sexual dysfunction.
General disorders and administration site conditions: Common: Fatigue, oedema peripheral, asthenia, malaise, feeling cold.
Uncommon: Application site reaction, influenza like illness, feeling of body temperature change, application site hypersensitivity, drug withdrawal syndrome, pyrexia*.
Rare: Application site dermatitis, application site eczema.
Endocrine disorders: Not known: Androgen deficiency.
* the assigned frequency (uncommon) is based on analyses of incidence including only adult and paediatric clinical study subjects with non-cancer pain.
Paediatric population: The safety of fentanyl patch was evaluated in 289 paediatric subjects (<18 years) who participated in 3 clinical studies for the management of chronic or continuous pain of malignant or non-malignant origin. These subjects received at least one dose of fentanyl patch and provided safety data (see Pharmacology: Pharmacodynamics under Actions).
The safety profile in children and adolescents treated with fentanyl patch was similar to that observed in adults. No risk was identified in the paediatric population beyond that expected with the use of opioids for the relief of pain associated with serious illness and there does not appear to be any paediatric-specific risk associated with fentanyl patch use in children as young as 2 years old when used as directed.
Based on pooled safety data from these 3 clinical studies in paediatric subjects, the most commonly reported (i.e. ≥10% incidence) adverse reactions were vomiting (33.9%), nausea (23.5%), headache (16.3%), constipation (13.5%), diarrhoea (12.8%), and pruritus (12.8%).
Tolerance, physical dependence, and psychological dependence can develop on repeated use of fentanyl patch (see Precautions).
Opioid withdrawal symptoms (such as nausea, vomiting, diarrhoea, anxiety, and shivering) are possible in some patients after conversion from their previous opioid analgesic to fentanyl patch or if therapy is stopped suddenly (see Dosage & Administration).
There have been very rare reports of newborn infants experiencing neonatal withdrawal syndrome when mothers chronically used fentanyl patch during pregnancy (see Use in Pregnancy & Lactation).
Cases of serotonin syndrome have been reported when fentanyl was administered concomitantly with highly serotonergic medicinal products (see Precautions and Interactions).
In very rare cases, soya-bean oil, refined can cause allergic reactions.