Chemical formula: BaOâ‚„S Molecular mass: 233.39 g/mol PubChem compound: 24414
Although this product is not contraindicated in pregnancy, we would like to point out that radiographic procedures may damage the foetus, particularly during the first trimester of pregnancy. Any examination should only be carried out after careful consideration of the benefit/risk of the procedure.
Since the absorption of barium sulfate is negligible, its use is not contraindicated during breastfeeding.
Following oral or rectal administration, barium sulfate is absorbed systemically in negligible amounts. Though barium sulfate is pharmacologically inert, no studies of its mutagenic or teratogenic potential are available.
Barium sulfate has negligible influence on the ability to drive and use machines.
Undesirable effects may occur during or after a procedure with barium sulfate.
Skin and subcutaneous disorders together with immune system disorders, reflecting allergic reactions either to barium sulfate or the product excipients, are among the most commonly reported effects; for example urticaria, erythema and rash.
Gastrointestinal disorders are also one of the most frequently reported class of undesirable effects; for example diarrhoea, nausea, abdominal pain/distention, constipation.
Within the table below, clinically significant adverse reactions are listed if they have been reported during post approval use of all barium sulfate formulations. Their frequency is not known, therefore relative reporting rate (for example, less commonly) compared to overall reporting for barium sulfate is used.
| MedDRA System Organ Class | Adverse events | |
|---|---|---|
| Clinical Trails | Post-marketing Surveillance | |
| Rare (≥1/10,000 to <1/1,000) | ||
| Infections and infestations | Appendicitis, Bacteraemia. Less commonly other infections have been reported including rare cases of Abscess intestinal, Liver abscess, Peritoneal infection and Pneumonia | |
| Blood and the lymphatic system disorders | Lymphadenopathy | |
| Immune system disorders | Hypersensitivity presenting with a wide range of signs and symptoms including skin and subcutaneous reactions such as urticaria, pruritus, rash, erythema and facial swelling. Potential hypersensitivity associated respiratory signs and symptoms including dyspnoea, pharyngeal oedema and throat tightness have been reported. Anaphylactic reaction and anaphylactic shock have been reported less commonly. | |
| Metabolism and nutrition disorders | Infrequent cases of Hyperglycaemia have been reported in diabetic patients | |
| Psychiatric disorders | Agitation, Confusional state, Nervousness and related symptoms have been reported during the administration of barium sulfate | |
| Nervous system disorders | Loss of consciousness, Syncope, Syncope vasovagal, Dizziness, Burning sensation, Headache, Dysarthria, Hypotonia | |
| Eye disorders | Eye disorders, including Eye swelling, usually associated with allergic reactions have been reported | |
| Ear and labyrinth disorders | Tinnitus | |
| Cardiac disorders | Bradycardia, Cyanosis, Tachycardia | |
| Vascular disorders | Hypotension, Pallor, Vasodilatation | |
| Respiratory, thoracic and mediastinal disorders | Bronchospasm, Dyspnoea, Laryngeal oedema, Pharyngeal oedema and pain, Throat irritation or tightness, Cough.When administered orally, Aspiration, Pneumonia aspiration. | |
| Gastrointestinal disorders | Abdominal pain Nausea; Vomiting | Gastrointestinal signs and symptoms are widely reported, it is not always possible to differentiate between pre-existing medical conditions and procedural complications. Events reported include: Intestinal ischemia, Constipation and in severe cases gastrointestinal blockage; Gastrointestinal inflammation, ulceration or perforation; Abdominal discomfort, abdominal distension; Diarrhoea; Colitis ulcerative may be aggravated; Retching; Flatulence; Swollen tongue |
| Skin and subcutaneous tissue disorders | Skin reactions are varied and most likely to be associated with allergic reactions. Reports include: Erythema, Dermatitis Contact, Excessive granulation tissue, Hyperhidrosis, Periorbital oedema, Pruritus, Rash, Swelling face, Urticaria | |
| Renal and urinary disorders | Dysuria | |
| General disorders and administration site conditions | Malaise, Pain, Swelling, Asthenia, Pyrexia, Face oedema | |
| Investigations | Electrocardiogram abnormal | |
| Injury and poisoning | Intravasation by barium sulfate, associated with pre-existing bowel disease or diverticulitis, has been reported rarely, Barium impaction. | |
More rarely and depending on the route of administration, i.e. oral or rectal, the following procedural complications have been reported:
Infections (e.g. peritonitis) subsequent to existing or new gastrointestinal perforation. Complications include adhesions and granuloma.
Subsequent to existing or procedural gastrointestinal trauma, intravasation of barium sulfate with rare subsequent venous emboli formation, including the hepatic portal vein, vena cava and pulmonary embolism that may be fatal in approx 50% of cases.
Following oral administration, aspiration, with pulmonary complications, may occur and may be fatal in rare cases.
Very rare cases of death associated with barium sulfate administration have been reported in the literature. The majority of the deaths relate to procedural complications usually caused by failure to follow generally accepted radiological practice. Some cases had a history indicating that barium sulfate administration was highly unlikely to be a primary or even secondary causative factor in patient fatality.
The type of adverse reactions is similar in children and adults.
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