What are the side effects of Paxlovid (nirmatrelvir and ritonavir)?

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Side Effects of Paxlovid (Nirmatrelvir and Ritonavir)

Paxlovid commonly causes dysgeusia (altered taste sensation) and diarrhea, with no significant increase in adverse effects leading to drug discontinuation compared to placebo. 1

Common Side Effects

The most frequently reported side effects of Paxlovid include:

  • Altered sense of taste (dysgeusia) - often described as metallic or bitter taste 2
  • Diarrhea 1, 2
  • Headache 2, 3
  • Vomiting 2
  • Abdominal pain 2
  • Nausea 2
  • High blood pressure 2
  • Feeling generally unwell 2

Serious Side Effects

While less common, Paxlovid may cause serious side effects that require immediate medical attention:

1. Allergic Reactions

  • Stop taking Paxlovid and seek medical help immediately if you experience: 2
    • Skin rash, hives, blisters, or peeling skin
    • Painful sores or ulcers in mouth, nose, throat, or genital area
    • Swelling of mouth, lips, tongue, or face
    • Trouble swallowing or breathing
    • Throat tightness
    • Hoarseness

2. Liver Problems

  • Contact your healthcare provider right away if you develop: 2
    • Loss of appetite
    • Yellowing of skin and eyes
    • Dark-colored urine
    • Pale colored stools
    • Itchy skin
    • Abdominal pain

Neurological Side Effects

Recent analysis of FDA adverse event data shows that Paxlovid is associated with a higher number of neurological adverse events compared to other COVID-19 medications, with a strong signal value (ROR = 2.27) 3. The most common neurological side effects include:

  • Dysgeusia (altered taste)
  • Ageusia (loss of taste)
  • Headache
  • Anosmia (loss of smell)

These neurological side effects appear to be more common in female patients and typically occur within the first 30 days of treatment 3.

Drug Interactions - A Major Concern

The ritonavir component of Paxlovid is a potent inhibitor of CYP3A enzymes, which can lead to significant drug-drug interactions 1, 2, 4. This is one of the most important considerations when prescribing Paxlovid:

  • Ritonavir affects metabolism and clearance of many medications during treatment and possibly for several days after treatment completion 1
  • Approximately 60% of available medications have oxidative metabolism involving CYP3A4, making interactions common 5
  • Of the top 100 most prescribed medications in the US for high-risk COVID-19 patients, 30 have potential interactions with Paxlovid 6

Medications contraindicated with Paxlovid include: 2

  • Cardiovascular drugs (amiodarone, flecainide, propafenone, quinidine, etc.)
  • Psychiatric medications (lurasidone, triazolam, etc.)
  • Pain medications
  • Certain statins (lovastatin, simvastatin)
  • Ergot derivatives
  • Various other medications

Special Considerations

Renal Impairment

  • For moderate renal impairment (eGFR 30-59 mL/min): Reduce dose to 150 mg nirmatrelvir with 100 mg ritonavir twice daily 1, 2
  • For severe renal impairment (including hemodialysis): Special dosing schedule required 2

Immunosuppressive Drugs

When coadministered with Paxlovid, immunosuppressive drugs require significant dosage adjustments: 4

  • Tacrolimus: Should be discontinued or given as microdose on day 1
  • Cyclosporine: Reduce to 20% of initial dosage during antiviral treatment
  • mTOR inhibitors: Require dosage adjustments
  • Mycophenolic acid and corticosteroids: Less affected

Effectiveness vs. Side Effects

Despite these side effects, Paxlovid has demonstrated significant benefits in reducing:

  • Hospitalization risk by 39% (absolute risk reduction of 0.9 percentage points) 7
  • Death risk by 61% (absolute risk reduction of 0.2 percentage points) 7

These benefits are particularly pronounced in patients aged 65+ years 7, making the side effect profile generally acceptable given the mortality and morbidity benefits.

Key Practical Points

  1. Always check for drug interactions before prescribing (use resources like the Liverpool COVID-19 drug interaction tool) 1
  2. Take Paxlovid with or without food at approximately the same time each day 2
  3. Complete the full 5-day treatment course 2
  4. If a dose is missed within 8 hours, take it as soon as possible; if more than 8 hours have passed, skip the missed dose 2
  5. Do not double the dose to make up for a missed dose 2

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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