Published: 2 December 2021


Gathering knowledge from adverse reaction reports: December 2021

Published: 2 December 2021
Prescriber Update 42(4): 57–59
December 2021

Adverse reaction reporting is an important component of medicine safety monitoring. Case reports can highlight significant safety issues concerning therapeutic products and their use.

The table below presents a selection of recent informative cases from the Centre for Adverse Reactions Monitoring (CARM) database.

Case detailsa,b Reaction description and data sheet informationb,c
CARM ID: 141199
Age: 16
Gender: Female
Medicine(s): Tramadol, sertraline
Reaction(s): Seizure
A patient taking tramadol and sertraline experienced seizures.
The Arrow-Tramadol data sheet states that tramadol can induce convulsions and increase the potential for selective serotonin re-uptake inhibitors (eg, sertraline) and other seizure threshold lowering agents to cause convulsions. The Setrona data sheet states that the risk of serotonin syndrome with SSRIs is increased with concomitant use of serotonergic medicines, including tramadol. Co-administration of sertraline with other medicines that enhance the effects of serotonergic neurotransmission, such as tramadol should be undertaken with caution and avoided whenever possible.
CARM ID: 141227
Age: 13
Stevens-Johnson syndrome
Three weeks after starting treatment with terbinafine, the patient developed a rash and mouth ulcers. He also had deranged liver function tests. Stevens-Johnson syndrome was suspected.
Stevens-Johnson Syndrome is listed as a very rare adverse reaction in the Deolate data sheet. Treatment must be discontinued if a skin rash develops.
CARM ID: 141350
Toxicity to various agents
A patient taking a daily dose of 500 mcg of digoxin developed signs of toxicity, including blurred vision, bradycardia, visual hallucinations, confusion and unsteadiness. His digoxin level was measured at 8.6 nmol/L.
The therapeutic serum digoxin concentration range is 0.8 to 2 ng/mL (1 to 2.6 nmol/L). The Lanoxin data sheet states that digoxin toxicity is more commonly associated with serum digoxin concentration greater than 2 ng/mL. However, serum digoxin concentration should be interpreted in the clinical context. Toxicity may occur with lower digoxin serum concentrations. In deciding whether a patient's symptoms are due to digoxin, the clinical state together with the serum potassium level and thyroid function are important factors. For elderly patients, high serum digoxin levels and associated toxicity can occur quite readily, unless doses lower than those in non-elderly patients are used.
CARM ID: 141825
Arthralgia, muscular weakness, tendonitis, dyspnoea, disturbance in attention
The patient experienced ongoing symptoms several months after stopping ciprofloxacin.
The Cipflox data sheet states that fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially persistent adverse reactions involving different body systems that have occurred together in the same patient. These include, but are not limited to, serious adverse reactions involving the nervous system and the musculoskeletal system. Tendinitis and tendon rupture (predominantly Achilles tendon) sometimes bilateral, may occur with ciprofloxacin, even within the first 48 hours of treatment. Cases occurring up to several months after completion of ciprofloxacin therapy have been reported. Advise patients that if any sign of tendonitis occurs (eg, painful swelling, inflammation), they should rest the affected extremity, avoid inappropriate physical activity and seek medical advice. The antibiotic treatment should be discontinued.
CARM ID: 135982
Death, colitis, megacolon, sepsis
A patient taking clozapine experienced constipation and was prescribed laxatives. Some months later, the patient was found unresponsive in bed and he subsequently passed away. The post-mortem identified megacolon with evidence of colitis, possibly leading to sepsis.
The Clopine and Clozaril data sheets state that careful monitoring for constipation is required during treatment with clozapine and patients should be questioned about their bowel habits. Onset of constipation must be identified early and managed effectively to prevent complications. Clozapine has been associated with varying degrees of impairment of intestinal peristalsis, ranging from constipation to intestinal obstruction, faecal impaction, paralytic ileus, megacolon and intestinal infarction/ischaemia.


  1. Only the medicines suspected to have caused the reaction are listed in the table.
  2. The reactions listed in the ‘Case details’ column are coded according to the Medical Dictionary for Regulatory Activities (MedDRA), an internationally used set of standardised terms relating to medical conditions, medicines and medical devices. The reactions listed in the ‘Reaction description’ column are based on what was reported to CARM, and do not always match the MedDRA term.
  3. If the suspect medicine’s brand name is not described in the report to CARM, only the data sheet for the funded medicine is included in the table.

Information about suspected adverse reactions reported to CARM is available on the Medsafe website using the Suspected Medicines Adverse Reaction Search (SMARS).

By selecting the ingredient of a medicine, you can find out:

  • the number of reports and suspected adverse reactions for that ingredient. The suspected reactions are grouped by body system or organs (Summary report)
  • single case reports, listing the medicines involved that contain the ingredient and the suspected adverse reactions (Detail report).
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