Rimantadine
/api/v1/drug/rimantadineMechanism of action
Sourced from openFDAThe mechanism of action of rimantadine is not fully understood. Rimantadine appears to exert its inhibitory effect early in the viral replicative cycle, possibly inhibiting the uncoating of the virus.
Indications
Sourced from openFDA- Rimantadine hydrochloride tablet is indicated for the prophylaxis and treatment of illness caused by various strains of influenza A virus in adults (17 years and older). Rimantadine hydrochloride tablet is indicated for prophylaxis against influenza A virus in children (1 year to 16 years of age).ICD-10: J11.1
Contraindications
Sourced from openFDA- Rimantadine hydrochloride tablet is contraindicated in patients with known hypersensitivity to drugs of the adamantane class, including rimantadine and amantadine.contraindicated
Dosage & administration
Sourced from openFDAFor Prophylaxis in Adults and Children Adults (17 years and older) The recommended adult dose of rimantadine hydrochloride is 100 mg twice a day. Study durations ranged from 11 days to 6 weeks in adult and elderly patients. In patients with severe hepatic dysfunction, severe renal impairment (CrCl 5 to 29 mL/min) or renal failure (CrCl ≤ 10 mL/min) and in elderly nursing home patients, a dose reduction to 100 mg daily is recommended. Because of the potential for accumulation of rimantadine metabolites during multiple dosing, patients with hepatic or renal impairment should be monitored for adverse effects. Children (1 year to 16 years of age) Study duration ranged from 5 weeks to 6 weeks in pediatric subjects. In children 1 year to 9 years of age, rimantadine hydrochloride should be administered once a day, at a dose of 5 mg/kg but not exceeding 150 mg. For children 10 years of age or older, use the adult dose. (see Directions for Compounding of an Oral Suspension from Rimantadine Hydrochloride Tablets to prepare an oral suspension for administration to children and patients with difficulty swallowing tablets). Children (Birth to 11 months) The safety and efficacy of rimantadine hydrochloride for prophylaxis of influenza in pediatric patients younger than 1 year of age have not been established. For Treatment in Adults Adults (17 years and older) The recommended adult dose of rimantadine hydrochloride is 100 mg twice a day for 7 days.
Adverse reactions
Sourced from openFDAIn 1,027 patients treated with rimantadine hydrochloride in controlled clinical trials at the recommended dose of 200 mg daily, the most frequently reported adverse events involved the gastrointestinal and nervous systems. Incidence >1%: Adverse events reported most frequently (1 % to 3%) at the recommended dose in controlled clinical trials are shown in the table below. Rimantadine (n=1,027) Control (n=986) Nervous System Insomnia 2.1% 0.9% Dizziness 1.9% 1.1% Headache 1.4% 1.3% Nervousness 1.3% 0.6% Fatigue 1.0% 0.9% Gastrointestinal System Nausea 2.8% 1.6% Vomiting 1.7% 0.6% Anorexia 1.6% 0.8% Dry mouth 1.5% 0.6% Abdominal Pain 1.4% 0.8% Body as a Whole Asthenia 1.4% 0.5% Less frequent adverse events (0.3 to 1%) at the recommended dose in controlled clinical trials were: Gastrointestinal System: diarrhea, dyspepsia; Nervous System: impairment of concentration, ataxia, somnolence, agitation, depression; Skin and Appendages: rash; Hearing and Vestibular: tinnitus; Respiratory: dyspnea. Additional adverse events (less than 0.3%) reported at recommended doses in controlled clinical trials were: Nervous System: gait abnormality, euphoria, hyperkinesia, tremor, hallucination, confusion, convulsions; Respiratory: bronchospasm, cough; Cardiovascular: pallor, palpitation, hypertension, cerebrovascular disorder, cardiac failure, pedal edema, heart block, tachycardia, syncope; Reproduction: non-puerperal lactation; Special Senses: taste loss/change, parosmia.
Use in specific populations
Sourced from openFDAPregnancy Teratogenic Effects : There are no adequate and well-controlled studies in pregnant women. Rimantadine is reported to cross the placenta in mice. Rimantadine has been shown to be embryotoxic in rats when given at a dose of 200 mg/kg/d (11 times the MRHD based on mg/m 2 ). At this dose the embryotoxic effect consisted of increased fetal resorption in rats; this dose also produced a variety of maternal effects including ataxia, tremors, convulsions and significantly reduced weight gain. No embryotoxicity was observed when rabbits were given doses up to 50 mg/kg/d (approximately 0.1 times the MRHD based on AUC), but evidence of a developmental abnormality in the form of a change in the ratio of fetuses with 12 or 13 ribs were noted. This ratio is normally about 50:50 in a litter but was 80:20 after rimantadine treatment. However, in a repeat embryofetal toxicity study in rabbits at doses up to 50 mg/kg/d (approximately 0.1 times the MRHD based on AUC), this abnormality was not observed. Nonteratogenic Effects: Rimantadine was administered to pregnant rats in a peri- and postnatal reproduction toxicity study at doses of 30 mg/kg/d, 60 mg/kg/d and 120 mg/kg/d (1.7, 3.4 and 6.8 times the MRHD based on mg/m 2 ).
Pharmacokinetics
Sourced from openFDA- Metabolism
- Although the pharmacokinetic profile of rimantadine hydrochloride has been described, no pharmacodynamic data establishing a correlation between plasma concentration and its antiviral effect are available. Rimantadine hydrochloride is absorbed after oral administration.
Overdosage
Sourced from openFDAAs with any overdose, supportive therapy should be administered as indicated. Overdoses of a related drug, amantadine, have been reported with adverse reactions consisting of agitation, hallucinations, cardiac arrhythmia and death. The administration of intravenous physostigmine (a cholinergic agent) at doses of 1 to 2 mg in adults (Ref. 7) and 0.5 mg in children (Ref. 8) repeated as needed as long as the dose did not exceed 2 mg/hour has been reported anecdotally to be beneficial in patients with central nervous system effects from overdoses of amantadine.
Approval history
Sourced from openFDA- Aug 30, 2002ANDAANDA076132Impax Labs
FAERS reports
- 1Drug Ineffective415%
- 2Malaise312%
- 3Convulsion27.7%
- 4Drug Resistance27.7%
- 5Febrile Neutropenia27.7%
- 6Hyperhidrosis27.7%
- 7Hyperkalaemia27.7%
- 8Myocardial Infarction27.7%
- 9Pneumocystis Jiroveci Pneumonia27.7%
- 10Pneumonia27.7%
- 11Staphylococcal Bacteraemia27.7%
- 12Abdominal Discomfort13.8%
- 13Abdominal Distension13.8%
- 14Abdominal Pain13.8%
- 15Abortion Spontaneous13.8%
Literature
Recent PubMed references pinned to Rimantadine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Environmental occurrence of amantadine and rimantadine in aquaculture pond sediments: application of a newly developed LC-MS/MS method.Environmental monitoring and assessment · 2026 · Zhou X, Cui S, Wang X, et al.PMID 41879860DOI 10.1007/s10661-026-15223-2
- Metabolic profiling to evaluate the impact of amantadine and rimantadine on the secondary metabolism of a model organism.Scientific reports · 2023 · Kostina-Bednarz M, Płonka J, Barchanska H, et al.PMID 37798340DOI 10.1038/s41598-023-43540-w
- [Determination of amantadine, rimantadine and dimethylamantadine residues in poultry by ultra-performance liquid chromatography-tandem mass spectrometry].Wei sheng yan jiu = Journal of hygiene research · 2023 · Ma J, Chen Y, Zhang M, et al.PMID 37062693DOI 10.19813/j.cnki.weishengyanjiu.2023.02.018
- Amantadine and Rimantadine Inhibit Hepatitis A Virus Replication through the Induction of Autophagy.Journal of virology · 2022 · Sasaki-Tanaka R, Shibata T, Moriyama M, et al.PMID 36040176DOI 10.1128/jvi.00646-22
- Repurposing potential of rimantadine hydrochloride and development of a promising platinum(II)-rimantadine metallodrug for the treatment of Chikungunya virus infection.Acta tropica · 2022 · Santos IA, Pereira AKDS, Guevara-Vega M, et al.PMID 34979144DOI 10.1016/j.actatropica.2021.106300
- Amantadine has potential for the treatment of COVID-19 because it inhibits known and novel ion channels encoded by SARS-CoV-2.Communications biology · 2021 · Toft-Bertelsen TL, Jeppesen MG, Tzortzini E, et al.PMID 34853399DOI 10.1038/s42003-021-02866-9
- Efficacy of Ion-Channel Inhibitors Amantadine, Memantine and Rimantadine for the Treatment of SARS-CoV-2 In Vitro.Viruses · 2021 · Zhou Y, Gammeltoft KA, Galli A, et al.PMID 34696509DOI 10.3390/v13102082
- Development of a molecularly imprinted microspheres-based microplate fluorescence method for detection of amantadine and rimantadine in chicken.Food additives & contaminants. Part A, Chemistry, analysis, control, exposure & risk assessment · 2021 · Zhang T, Zhang L, Liu JX, et al.PMID 33989121DOI 10.1080/19440049.2021.1914868
Clinical trials
The 4 most recently updated of 4 ClinicalTrials.gov registrations naming Rimantadine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Prophylactic Efficacy of Relenza Against Influenza A and BCompleted · Observational · 171,705 enrolled · GlaxoSmithKlineNCT01156701updated 2017-05-30
- A Pharmacokinetic Study on Co-administration of Tamiflu (Oseltamivir) and Rimantadine in Healthy VolunteersCompleted · Phase 1 · Interventional · 24 enrolled · Hoffmann-La RocheNCT01172847updated 2016-08-19
- Hepatitis C Rimantadine and Antiviral Combination TherapyCompleted · Observational · 10 enrolled · The Leeds Teaching Hospitals NHS TrustNCT01413490updated 2015-03-31
- Chart Review of Antivirals for Influenza in InfantsCompleted · Observational · 200 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)NCT00311701updated 2011-05-13
Frequently asked questions
- How does Rimantadine work?
- The mechanism of action of rimantadine is not fully understood. Rimantadine appears to exert its inhibitory effect early in the viral replicative cycle, possibly inhibiting the uncoating of the virus.
- What is Rimantadine used for?
- According to FDA labeling, Rimantadine carries indications including: Rimantadine hydrochloride tablet is indicated for the prophylaxis and treatment of illness caused by various strains of influenza A virus in adults (17 years and older). Rimantadine hydrochloride tablet is indicated for prophylaxis against influenza A virus in children (1 year to 16 years of age).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Rimantadine?
- Rimantadine is classified as Cyclic amines, Influenza A M2 Protein Inhibitor, Ion Channel Interactions, M2 Protein Inhibitors, Cellular Synthetic Activity Alteration.
- What are the brand names for Rimantadine?
- Rimantadine is marketed under brand names including Flumadine.
- What are the contraindications for Rimantadine?
- Rimantadine labeling lists contraindications including: Rimantadine hydrochloride tablet is contraindicated in patients with known hypersensitivity to drugs of the adamantane class, including rimantadine and amantadine.. Always consult the full prescribing information and a clinician.
rimantadine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.