Published: 4 March 2021


Gathering knowledge from adverse reaction reports: March 2021

Published: 4 March 2021
Prescriber Update 42(1): 8
March 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: 138173
Age: 81
Gender: Female
Medicine(s): Sodium valproate
Reaction(s): Encephalopathy, hyperammonaemia
The patient presented to hospital with confusion, difficulty conversing, lethargy, nausea and loss of balance. Laboratory tests showed elevated ammonia levels. The patient was diagnosed with hyperammonaemic encephalopathy, secondary to sodium valproate.
The Epilim data sheet states that hyperammonaemia can occur in patients during treatment with sodium valproate/valproic acid. In patients who develop unexplained lethargy and vomiting or changes in mental status, further investigations and hyperammonaemic encephalopathy should be considered. In these patients, EEG and ammonia level should be checked and, if ammonia is increased, valproate therapy should be discontinued.
CARM ID: 138298
Age: 29
Gender: Female
Medicine(s): Sertraline
Reaction(s):Libido decreased, anorgasmia
The patient experienced decreased libido and anorgasmia during treatment with sertraline. The treatment was discontinued but the symptoms have persisted.
The Arrow Sertraline data sheet states that selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction. There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.

See also the Consumer Information Leaflet, Medicines for depression or other mental disorders and difficulties with sex (sexual dysfunction).
CARM ID: 138341
Age: 80
Gender: Female
Medicine(s): Codeine
Reaction(s): Anaphylactic reaction
Within 15 minutes of codeine administration, the patient experienced itchiness in her hands, which then progressed to lip swelling and facial oedema, flushed skin, a drop in blood pressure and reduced responsiveness. Treatment for anaphylaxis was administered and the reaction eased.
Allergic reactions are listed in the Codeine PSM data sheet, including rash, urticaria, pruritis, difficulty breathing, increased sweating, redness of flushed face and angioedema.
CARM ID: 138590
Age: 40
Gender: Female
Medicine(s): Phenylephrine, amitriptyline
Reaction(s): Dry mouth, dry skin, palpitations, tachycardia
The patient took her prescribed amitriptyline dose, and soon after took a Sudafed PE (phenylephrine) tablet for sinus congestion. The patient presented to hospital with palpitations, dry mouth, behavioural changes and increased blood pressure. A drug interaction between amitriptyline and epinephrine was suspected.
The Arrow-Amitriptyline data sheet states that amitriptyline may potentiate the cardiovascular effects of adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine, and phenylpropanolamine (eg, as contained in local and general anaesthetics and nasal decongestants).
CARM ID: 138832
Age: 49
Gender: Male
Medicine(s): Vildagliptin
Reaction(s): Pancreatitis
A patient taking vildagliptin was admitted to hospital with pancreatitis.
The Galvus data sheet states that acute pancreatitis has been reported in patients treated with vildagliptin (frequency unknown). Inform patients of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain. Discontinue treatment if pancreatitis is suspected.
CARM ID: 138877
Age: 31
Gender: Female
Medicine(s): Varenicline
Reaction(s): Seizure
A patient with a history of seizures felt unwell soon after taking the first dose of varenicline. She had three seizures the next day.
The Varenicline Pfizer data sheet states that there have been reports of seizures in patients with or without a history of seizures, treated with varenicline. Varenicline should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
CARM ID: 139060
Age: 15
Gender: Male
Medicine(s): Isotretinoin
Reaction(s): Proteinuria
The patient developed proteinuria soon after starting treatment with isotretinoin. Although isotretinoin was immediately discontinued, the proteinuria worsened before resolving four weeks after stopping treatment.
Proteinuria is listed as a rare adverse reaction in the Oratane data sheet.


  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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