Can Singulair (montelukast) cause back pain?

Back Pain and Montelukast (Singulair)

Montelukast (Singulair) is not known to cause back pain as a common side effect, and there is no substantial evidence linking it to back pain specifically. Based on the FDA drug label and available evidence, back pain is not listed among the common side effects of this medication.

Side Effect Profile of Montelukast

• The FDA drug label for Singulair lists common side effects including increased bleeding tendency, allergic reactions, drowsiness, pins and needles/numbness, seizures, palpitations, nose bleeds, diarrhea, indigestion, inflammation of the pancreas, nausea, vomiting, hepatitis, and bruising 1
• More concerning side effects include behavior and mood-related changes such as agitation, depression, anxiety, hallucinations, irritability, and suicidal thoughts 1
• A 2022 study found that neuropsychiatric reactions were common with montelukast use, particularly sleep disturbances (15.1%), agitation (10.4%), and hyperactivity (6.8%) 2
• Pain was reported in 9.4% of patients in one study, but this was not specifically identified as back pain 2

Montelukast's Mechanism and Indications

• Montelukast is a selective leukotriene receptor antagonist (LTRA) that inhibits the cysteinyl leukotriene 1 (CysLT1) receptor 3
• It is FDA-approved for:
  • Asthma management in adults and children
  • Prevention of exercise-induced bronchoconstriction
  • Treatment of seasonal and perennial allergic rhinitis 1
• Montelukast is typically taken once daily at a dose of 10mg for adults and adolescents 15 years and older 1

Back Pain Considerations

• Back pain is not listed as a common side effect in the FDA drug label for montelukast 1
• Interestingly, in studies of other medications (such as bempedoic acid), back pain has been reported as a common adverse effect, showing that back pain is typically monitored and reported when present 4
• While one research study found montelukast could attenuate neuropathic pain in an animal model by inhibiting inflammatory pathways 5, this does not suggest it causes back pain but rather might potentially help with certain types of pain

Management Recommendations

• If a patient taking montelukast experiences back pain:
  • Consider other more common causes of back pain, as it is unlikely to be related to montelukast 4
  • For back pain management, NSAIDs have demonstrated effectiveness for pain relief in patients with back pain for periods ranging from 2 to 12 weeks (Category A2 evidence) 4
  • Opioid therapy may be considered for severe back pain that is unresponsive to other treatments 4
• Continue montelukast if it is effectively managing the patient's asthma or allergic rhinitis, as there is insufficient evidence to suggest it causes back pain 4
• Monitor for the more common and concerning side effects of montelukast, particularly neuropsychiatric symptoms 1, 2

Clinical Pearls

• Back pain is extremely common in the general population and often coincidental with medication use rather than caused by it 4
• When evaluating potential medication side effects, always consider the established side effect profile from FDA labeling and high-quality clinical studies 1
• Montelukast remains an effective treatment option for asthma and allergic rhinitis with a generally favorable safety profile when used appropriately 6, 7