For full safety profile, please consult the SmPC
Adverse Events
Adverse events1
Adverse reactions are classified into the following categories in order of frequency:
- 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); 000)
- Not known (cannot be estimated from the available data)
System organ class
Undesirable side effects
Frequency
Immune system disorders
Hypersensitivity
Not known
Endocrine disorders
Hyperthyroidism
Common
Psychiatric disorders
Insomnia
Very common
Nervousness
Common
Agitation
Not known
Nervous system disorders
Headache
Very common
Pseudotumor cerebri particularly in children
Rare
Tremors
Not known
Cardiac disorders
Palpitations
Very common
Tachycardia
Common
Cardiac arrhythmias, anginal pain
Not known
Vascular disorders
Flushing
Circulatory collapse in low birth weight preterm neonates
Circulatory collapse in low birth weight preterm neonates
Not known
Gastrointestinal disorders
Diarrhoea, vomiting and nausea
Not known
Skin and subcutaneous
disorders
Angioedema, rash, uticaria,
sweating
Not known
Musculoskeletal and connective tissue disorders
Muscle weakness and cramps, osteoporosis at suppressive doses of levothyroxine, especially in postmenopausal women, manly when treated for a long period
Not known
Reproductive system and breast disorders
Menstrual irregularities
Not known
General disorder and administration site conditions
Heat intolerance, fever
Not known
Investigations
Weight loss
Not known
Adverse reactions should be reported.
Reporting forms and information can be found at
https://www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play
or Apple App Store.
Adverse reactions should also be reported to
Serb SAS via email at medinfo.uk1@serb.eu
Reporting forms and information can be found at
https://www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play
or Apple App Store.
Adverse reactions should also be reported to
Serb SAS via email at medinfo.uk1@serb.eu
References:
- Levothyroxine SERB 200 mcg/ml solution for injection/infusion Summary of Product Characteristics (SmPC)