Tegretol Adverse Reactions

Certain types of adverse effects - e.g. central nervous system (CNS) adverse effects (dizziness, headache, ataxia, drowsiness, exhaustion, diplopia), gastrointestinal disturbances (nausea, vomiting) and allergic skin reactions - are uncommon or common, particularly at the start of Tegretol therapy (if the initial dosage is too high) and in elderly patients.
Dose-dependent adverse effects usually abate within a few days, either spontaneously or after transient dose reduction. The occurrence of CNS adverse effects may also be a manifestation of relative overdosage or of significant fluctuation in plasma levels. In such cases, it is advisable to monitor plasma concentrations.
Frequency estimates: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10 000 to <1/1000), very rare (<1/10 000).
Blood and lymphatic system disorders: Very common: Leukopenia (11%), persistent in 2% of cases.
Common: Eosinophilia, thrombocytopenia.
Rare: Lymphadenopathy.
Very rare: Leukocytosis, agranulocytosis, aplastic anaemia, pancytopenia, pure red cell aplasia, anaemia, megaloblastic anaemia, reticulocytosis, haemolytic anaemia.
Immune system disorders: Rare: Delayed multi-organ-hypersensitivity syndrome with various combinations of fever, exanthema, vasculitis, lymphadenopathy, pseudolymphoma, arthralgia, leukopenia, eosinophilia, hepatosplenomegaly, abnormal liver function tests and vanishing bile duct syndrome (destruction and disappearance of the intrahepatic bile ducts), occuring in various combinations. Other organs may also be affected (e.g. lungs, kidneys, pancreas, myocardium, colon).
Very rare: Anaphylactic reactions, hypogammaglobulinaemia, angioedema.
Endocrine disorders: Common: Oedema, fluid retention, weight gain; hyponatraemia and reduced plasma osmolality due to an antidiuretic hormone (ADH)-like effect, leading in rare cases to water intoxication with lethargy, nausea, vomiting, headache, confusion, neurological disturbances, seizures, disorientation, reduced perception, visual disturbances or encephalopathy ("syndrome of inappropriate antidiuretic hormone secretion", SIADH).
Very rare: Gynaecomastia, galactorrhoea.
Metabolism and nutrition disorders: Rare: Folate deficiency, decreased appetite.
Very rare: Acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda.
Psychiatric disorders: Rare: Hallucinations (visual or acoustic), depression, restlessness, aggressive behaviour, agitation, confusion.
Very rare: Activation of psychosis.
Nervous system disorders: Very common: Dizziness (10-50%), ataxia (children 10.4%, adults 50%), somnolence.
Common: Headache, diplopia.
Uncommon: Abnormal involuntary movements (e.g. tremor, asterixis, dystonia, tics); nystagmus.
Rare: Dyskinesia, oculomotor disturbances, speech disturbances (e.g. dysarthria, slurred speech), choreoathetoid disturbances, peripheral neuropathy, paraesthesias, paretic symptoms.
Very rare: Dysgeusia, neuroleptic malignant syndrome (NMS), aseptic meningitis with myoclonus and peripheral eosinophilia.
Eye disorders: Common: Accommodation disorders (e.g. blurred vision).
Very rare: Lens opacities, conjunctivitis.
Ear and labyrinth disorders: Very rare: Disturbances of hearing (e.g. tinnitus, hyperacusis, hypoacusis, change in pitch perception).
Cardiac disorders: Rare: Disturbances of cardiac conduction.
Very rare: Bradycardia, arrhythmias, AV block with syncope, heart failure, aggravation of coronary heart disease.
Vascular disorders: Rare: Hypertension or hypotension.
Very rare: Circulatory collapse, thrombophlebitis, thromboembolism (e.g. pulmonary embolism), vasculitis.
Respiratory, thoracic and mediastinal disorders: Very rare: Pulmonary hypersensitivity reactions characterized, for example, by fever, dyspnoea, pneumonitis or pneumonia.
Gastrointestinal disorders: Very common: Nausea, vomiting (both 8%).
Common: Dry mouth.
Uncommon: Diarrhoea, constipation.
Rare: Abdominal pain.
Very rare: Glossitis, stomatitis, pancreatitis.
Hepatobiliary disorders: Rare: Jaundice; cholestatic, parenchymal (hepatocellular) or mixed-type hepatitis, vanishing bile duct syndrome.
Very rare: Granulomatous hepatitis, liver failure.
Skin and subcutaneous tissue disorders: Very common: Allergic dermatitis, pruritus, urticaria (which may be severe).
Uncommon: Exfoliative dermatitis.
Rare: Systemic lupus erythematosus.
Very rare: Stevens-Johnson syndrome (reported as rare in some Asian countries; see Precautions), toxic epidermal necrolysis, photosensitivity reactions, erythema multiforme and nodosum, changes in skin pigmentation, purpura, acne, hyperhidrosis, hair loss, hirsutism.
Musculoskeletal and connective tissue disorders: Rare: Muscle weakness.
Very rare: Bone metabolism disorders (decrease in plasma calcium and 25-hydroxycholecalciferol) leading to osteomalacia/osteoporosis, arthralgia, myalgia, muscle spasms.
Renal and urinary disorders: Very rare: Tubulointerstitial nephritis, kidney failure, renal dysfunction (e.g. albuminuria, haematuria, oliguria and elevated BUN/azotaemia), urinary frequency, urinary retention.
Reproductive system and breast disorders: Very rare: Sexual dysfunction/erectile dysfunction, abnormal spermatogenesis (with decreased sperm count and/or motility).
There have been very rare reports of impaired male fertility and/or abnormal spermatogenesis (see also Pharmacology: Toxicology: Preclinical data under Actions).
General disorders and administration site conditions: Very common: Fatigue.
Examinations: Very common: Gamma-glutamyltransferase increased (due to hepatic enzyme induction), usually not clinically relevant.
Common: Elevated alkaline phosphatase.
Uncommon: Elevated transaminases.
Very rare: Elevated intraocular pressure, cholesterol increased (incl. HDL cholesterol and triglycerides), abnormal thyroid function test: decreased L-thyroxine (free thyroxine, thyroxine, tri-iodothyronine) and increased TSH values, usually without clinical manifestations, blood prolactin increased.
List of adverse drug effects from post-marketing spontaneous reports: The following adverse effects have been identified from post-marketing spontaneous reports. Because these reactions are voluntary reports from a population of uncertain size, it is not always possible to reliably state their true frequency.
Infections and infestations: Reactivation of human herpesvirus 6 infection.
Blood and lymphatic system disorders: Bone marrow failure.
Immune system disorders: Drug rash with eosinophilia and systemic symptoms (DRESS).
Nervous system disorders: Sedation, memory impairment.
Gastrointestinal disorders: Colitis.
Skin and subcutaneous tissue disorders: Acute generalized exanthematous pustulosis (AGEP), lichenoid keratosis, onychomadesis.
Musculoskeletal and connective tissue disorder:nFracture.
Investigations: Bone density decreased.
Injury, poisoning and procedural complications: Fall (associated with Tegretol treatment induced ataxia, dizziness, somnolence, hypotension, confusional state, sedation).